Regulatory Coordinator Resume Sample
Edythe Feest
19731 Wintheiser Groves,
Los Angeles,
CA
+1 (555) 292 4413
Work Experience
Senior Regulatory Coordinator
06/2016
-
PRESENT
Chicago, IL
- Review and analyze financial reports, trends, registration information and other relevant data to ensure compliance with FINRA, SEC and other applicable rules and regulations, including RSA client exchanges’ rules
- With moderate supervision from management, identify assigned firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansion of business
- Review examination findings prior to issuing the final examination report to assigned firms’ senior management
- Along with examination staff and examination and surveillance management personnel, evaluate firms’ responses to examination reports for satisfactory corrective action and help determine whether further action is required. Respond to firms in writing when responses are inadequate in order to request additional information
- Review and analyze financial reports, trends, registration information and other relevant data to ensure compliance with FINRA, SECA and other applicable rules and regulations, including RSA client exchanges’ rules
- With limited supervision, identify assigned firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business
- Review examination findings prior to issuing the final examination report to firms’ senior management
Regulatory Coordinator
04/2012
-
12/2015
Phoenix, AZ
- Assist in providing classroom training on technical matters for the Division’s staff, or other FINRA training programs; train less experienced regulatory coordinators
- Creates regulatory binders according to standard procedures/instructions
- Assists the Regulatory staff with projects as needed
- BDG experience in Operations or Quality Assurance
- Revise sponsor’s model informed consent form to comply with institutional requirements and obtain sponsor approval prior to submission to IRB
- Develop and maintain knowledge of institutional protocol submission procedures and requirements
- Maintain a processing and tracking system for all protocol related paperwork
- Collect and develop criteria information for protocol submission
- Coordinate the preparation and submission of new studies to appropriate committees, including DSMC, C/PRMC, COH IRB, WIRB, CIRB and other committees as necessary, including drafting and/or editing of informed consent document
Temporary Assistant Regulatory Coordinator
04/2007
-
03/2012
San Francisco, CA
- Along with examination staff and examination and surveillance management personnel, evaluate firms’ responses to examination reports for satisfactory corrective action and help determine whether further regulatory action is required. Respond to firms in writing when responses are inadequate in order to request additional information
- Working under minimal supervision, identify member firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business. Identify and recommend resolution to problem situations
- Working under moderate supervision, identify member firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business. Identify and recommend resolution to problem situations
- Identify member firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business. Identify and recommend resolution to problem situations
- Excellent communication and interpersonal skills. Musty represent department positively in person, by phone, and via written communication
- Oversees all aspects of regulatory compliance as it pertains to the essential components of
- Identify member firms’ potential financial or operational difficulties, as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business
- Work to ensure regulatory programs serve departmental goals and FINRA’s mission in an efficient and effective manner
Education
Thomas University
2002 - 2006
Bachelor's Degree in Business
Professional Skills
- Strong attention to detail, analytical skills, and the ability to interpret new laws and regulations
- Strong computer skills with knowledge of various software programs including Microsoft products
- Analyze, evaluate multiple solutions and solve complex problems using well developed critical and analytical thinking skills
- Three (3) years experience in a role requiring critical thinking and problem solving, managing complex projects that overlap between several clinical areas
- Excellent at interpreting technical documents including testing protocol, test reports etc
- Strong interest to learn about the technical elements of product development including manufacturing, machinery, chemistry, regulatory
- Communicate effectively both verbally and in writing. Ability to negotiate/mediate in a collaborative setting
How to write Regulatory Coordinator Resume
Regulatory Coordinator role is responsible for software, organizational, interpersonal, microsoft, analysis, database, computer, web, analytical, powerpoint.
To write great resume for regulatory coordinator job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Coordinator Resume
The section contact information is important in your regulatory coordinator resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Coordinator Resume
The section work experience is an essential part of your regulatory coordinator resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory coordinator responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory coordinator position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Coordinator resume experience can include:
- Demonstrated administrative experience with skill to coordinate complex activities and to use independent judgment to organize and prioritize tasks
- Demonstrates strong organizational skills and high level of attention to detail
- Strong interpersonal skills and ability to interface with institutional faculty, administrators, industry sponsors and regulatory agencies
- Communicates effectively verbally and in writing
- Learn new skills quickly and on-the-fly
- Understand the timing and implications of other team members’ startup requirements to ensure accurate and effectively timed submissions
Education on a Regulatory Coordinator Resume
Make sure to make education a priority on your regulatory coordinator resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory coordinator experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Coordinator Resume
When listing skills on your regulatory coordinator resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory coordinator skills:
- Effective written, verbal communication skills including presentation skills
- Excellent English oral and written communication skills, demonstrating a passion for quality and attention to detail
- Experience preparing and assembling FDA submissions. Experience working with electronic submission platforms, eCTD and submission planning is desired
- Demonstrated experience producing clinical regulatory documents, including proposals, consents, adverse event reports and close out documents
- RER – Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines
- CPIA certification and prior experience working as an IACUC Coordinator desirable
List of Typical Experience For a Regulatory Coordinator Resume
1
Experience For Senior Regulatory Coordinator Resume
- Interact with others by effectively communicating, both orally and in writing
- Meet deadlines while balancing multiple projects and departmental priorities
- Experience working in a collaboratively in a team environment
- Experience working in a collaboratively team environment
- Five (5) years of work experience in health care or compliance field
2
Experience For Research Regulatory Coordinator Resume
- Support in updating system with changes and providing assistance in consulting, interpretation and training on system updates
- Performs close out activities that include completing form documents for SPARS and posting documents in archival system or manually filing on site
- Represent ConocoPhillips on CAPP working groups and committees and influence new and emerging regulations
- Performs digital and paper file management and archiving using appropriate software systems and defined processes
- Ensures site is utilizing the current regulatory documents including the informed consent forms, protocols, forms, and investigator brochures
- Maintains the SAE Table noting all SAEs reported to sponsor, including initial and follow-ups, as well as those reported to the IRB
- Collect documents for Product Information File (PIF) including raw material information, stability reports, manufacturing process information, etc
- Tracks on an ongoing basis studies and study activities using a searchable database
- Compile data and documents, assist the Manager in designing reports and creating weekly email updates for the research community, state, or federal agencies
3
Experience For Regulatory Coordinator, Immuno Resume
- Adaptable to programmatic changes, providing fit for purpose options whilst maintaining compliance
- Familiarity with oncology clinical trials, EMR/patient data, federal funding reporting requirements, physician-initiated and pharma trials
- The opportunity to make a difference by protecting investors and maintaining market integrity through your work
- FDA, GCP, and NIH requirements relating to research involving human subjects
- Provide back up to Regulatory Coordinator III in providing updates to Disease Teams on protocol status
- (All SCL jobs) Regular attendance to perform work on site during regularly
- Resiliency and flexibility to work within a rapidly changing environment
- Expertise in relationship building with both internal and external customers (regulatory surveyors)
4
Experience For Cancer Clinical Trials Regulatory Coordinator Resume
- Meets with monitors from pharmaceutical companies and represents the Stony Brook Cancer Center Clinical Trials Office during these meetings
- Ensures compliance with all federal and local agencies including the FDA and local IRB
- Guides, advises, and educates asset and operational teams on all aspects of permitting rules and regulations
- Establishes and maintains professional working relationships with regulators, peers and internal stakeholders
- Provide feedback and guidance on emerging regulation and work with teams to develop and implement strategies to comply with new regulation
- Monitor regulatory changes, understand impacts of changing regulation on CPC operations and develop/issue internal communications on regulatory change
5
Experience For Clinical Regulatory Coordinator / Specialist Resume
- Provide guidance on requirements for regulatory licensing and approvals
- Maintains and disseminates accurate listings of active and potential studies to participating investigators
- Attends conferences regarding clinical trials and disseminates information to clinical staff
- Maintains the regulatory portion of the CRO database. This includes IRB approval dates, revision dates, protocol status, and adverse event tracking
- Establishes and maintains professional working relationships with regulators
- Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments
- Provide clear and concise professional communication in response to reviewing bodies and regulatory agencies
6
Experience For Internal Audit Regulatory Coordinator Internal Audit GF Resume
- Use judgment to interpret and apply federal and local regulations regarding clinical research
- Participates in development of Standard Operating Procedures and Work Instruction documents
- Completes necessary compliance and systems training to perform assigned tasks
- For the Clinical Monitoring/Site Management Plan (CMP/SMP)
- Thrive in a fast-paced, constantly changing environment
- Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
- Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
- Tracks documents pending site regulatory signatures
- Maintains updated physician credentials for network participants and other critical documentation ensuring compliance
7
Experience For Regulatory Coordinator Senior Resume
- Assist in review of materials prepared by other departments for filing with the regulator
- Monitor NYS Register for Public Service Department rule making activity
- Assist with monitoring regulatory proceedings in NYS
- Participates in the weekly research meeting
- Coordinates and collaborates with in-house and outside investigators and participating centers in multi-center studies to achieve research goals
- Provides support (including administrative/clerical) and information to staff, and external sources related to current research projects
- Participates in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested
- Reviews and adheres to department policies and procedures to maintain proficiency in operating guidelines
8
Experience For Audit & Regulatory Coordinator Resume
- Contribute to the development of the Regulatory Program and Center for Clinical Research as a high performing team
- Follow up communication with manufacturer on outstanding items
- File sharing with consultant and internal counterparts as needed
- Provide support for the Chair and Vice-Chairs as it relates to meeting preparation and application reviews
- Prepares and submits State and Federal well Applications for Permit to Drill (APD) and all subsequent reporting actions
- Ensures compliance with applicable Federal, Tribal, State and Local rules and regulations and internal company policies pertaining to assigned production areas
- Writes and edits technical documents and is knowledgeable of medical terminology, grammar, spelling, and punctuation
9
Experience For Compliance Regulatory Coordinator Resume
- Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials
- Meets with monitors from pharmaceutical companies and represents the medical center during these meetings
- Serves as a liaison with investigators and administrators on award-related verification of compliance related matters, including fCOI and RCR
- Able to perform computer-assisted research utilizing software and the Internet
- Assure that all site documents, including SOPs and study regulatory files are maintained in audit-ready condition
- Responsible for maintenance of study specific training documentation
- Supports the internal customer with regards to the safe use and handling of AkzoNobel products
10
Experience For HR Regulatory Coordinator Resume
- Computer competency including knowledge and proficiency in Microsoft Office Suite
- Flexibility/Adaptability in working in team environment
- Word processing software (e.g., Microsoft Word)
- E-mail/calendar/scheduling software (e.g., Microsoft Outlook)
- Desired backgrounds include healthcare licensing
- Team Player Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement
List of Typical Skills For a Regulatory Coordinator Resume
1
Skills For Senior Regulatory Coordinator Resume
- An expertise in risk analysis and proactive risk identification. Possess strong analytical skills
- Competency in risk analysis and proactive risk identification. Possess strong analytical skills
- Able to incorporate a strong customer service philosophy and effectively communicate to the office, committee and the research community
- A good level of understanding and experience of IT implementation and service management lifecycle, terminology and concepts
- Experience: Three (3) years healthcare or clinical research experience
- Understanding and experience with the following – Endangered Species Act, 404 Permitting with Army Corp of Engineers, NEPA, BLM Onshore Orders
2
Skills For Research Regulatory Coordinator Resume
- Understanding and experience with the following – Endangered Species Act, 404 Permitting with Army Corps of Engineers, NEPA, BLM Onshore Orders
- Experience in preparing animal study protocols and working with live vertebrate animals
- Strong understanding of drilling and completion operations
- Strong interest in the cosmetic industry, its products, packaging and manufacturing practices
- Knowledge of MS Office applications, database systems, and Internet. Experience using quantitative data analysis software helpful (e.g., SPSS, SAS, Minitab)
- 5+ or more in the regulatory labeling and management experience
3
Skills For Regulatory Coordinator, Immuno Resume
- Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
- Experience in handling confidential and sensitive material
- Experience using central and local IRBs
- Strong understanding of regulatory requirements and processes in British Columbia and Alberta
- Strong research, analytical, and problem-solving abilities
- Experience leading projects, stakeholders, and personnel
- Experience supporting emergency response activities and incident follow-up
- Experience working in regulatory affairs
- Research Regulations- Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
4
Skills For Cancer Clinical Trials Regulatory Coordinator Resume
- 6 mos-2 years Previous experience in a health care industry working in similar capacity required
- Experience working in DSM and SAP
- Experience of working with cross functional and global teams
- Experience of managing projects and ideally programs
- Plan and schedule tasks and projects and to maintain control of own and other’s work flow by prioritizing projects
- Industry regulatory experience
5
Skills For Clinical Regulatory Coordinator / Specialist Resume
- Four to six years of securities, compliance or financial regulatory experience
- Experience in Phase I Clinical Trials
- One year experience in human subject’s research, clinical trials, or regulatory knowledge
- Research Regulations Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
- Related research experience or research specific training
6
Skills For Internal Audit Regulatory Coordinator Internal Audit GF Resume
- Regulatory submission and/or clinical trials experience
- No previous QRA experience needed
- Experience in research or regulatory administration or other relevant area
- Prioritize, problem-solve and work under pressure in a deadline-driven environment
- Demonstrated ability to write informed consent documents
- Direct experience in upstream oil and gas
- Experience in the oil and gas industry
- Motivated self-starter with demonstrated leadership ability
7
Skills For Regulatory Coordinator Senior Resume
- Direct regulatory experience
- Relevant administrative experience required
- Relevant industrial, government or university experience
- Two (2) years previous experience with survey activities
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Direct related regulatory experience
- 6 mos-2 years Demonstrated ability to locate documents within an electronic health record system required
8
Skills For Audit & Regulatory Coordinator Resume
- Have a strong attention to detail and be highly organised
- Desired previous experience in a similar position
- Ensures the quantity and quality of data meets specific project objectives. Maintains validity and verifies accuracy of data
- Excellent analytical mind and solution oriented
- Experience in executing multiple projects simultaneously
9
Skills For Compliance Regulatory Coordinator Resume
- Experience working with sponsor monitor representatives
- Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations for research administration
- Drilling, completion, recompletion, plugging, well testing, injection well applications, annual testing, annual regulatory reports
- Challenging work environment in that there is continuous learning and constantly changing landscape
- Depending on position within the institution, reviews and has general understanding of the research protocols in order to ensure site compliance
- Ongoing training and education of federal policy and regulations that impact human subjects research and quality assurance requirements
- Willing and able to travel 15- 20% of the time
- Understanding of federal regulations for the use of vertebrate animals in research
10
Skills For HR Regulatory Coordinator Resume
- Working knowledge of BLM Well Information System (WIS) and AFMSS
- Evaluating and managing documentation regarding the protocol
- Taking minutes for two monthly meetings
- Preparing product registration documents as needed
- Meeting agenda construction
- Performs formatting, printing and scanning cover letters, preparing shipping materials according to company requirements and submitting the package to FDA
- Basic knowledge of oil and gas land requirements including surface and mineral agreements, spacing orders, drilling/pooling units, and leases
- Assist quality manager in collecting and analyzing quality documentation for each project including stability and compatibility study, functionality testing….
- Prepares for all monitoring visits by ensuring that all documents are filed and organized as well as resolving all previous outstanding regulatory issues
List of Typical Responsibilities For a Regulatory Coordinator Resume
1
Responsibilities For Senior Regulatory Coordinator Resume
- Work closely alongside regulatory technologists in order to ensure they put in place PIFs and any other documentation that’s required for International compliance and registration
- Have a proven understanding and knowledge of the International and EU Cosmetics Regulations
- Working with the Company’s international distributors to provide information and data that is needed to ensure compliance in other territories
- Write requisitions and send requisitions over to purchasing when shipping and picking inventory gets low on supplies
- Continually keep current on regulations regarding limits on chemical packaging assuring the repack department stays within the allowed limits
- Supports preparatory study activities by designing site workflow and study training programs
- Pursues additional research education opportunities by attending Research Administration Training Series
2
Responsibilities For Research Regulatory Coordinator Resume
- Count supplies each night for shipping and send an email to Neck Rd and shelly Rd to have supplies brought over each morning
- Participates in shared on-call responsibilities for enrolling study patients in the ED
- Share information, transferring knowledge and expertise to global team members
- Prepares for and participates in audits made by sponsors or federal agencies during course and at the close of the study
- Enter all errors in Bump Logs and send to the shipping manager
- Directs truck drivers regarding shipments and inquiries
- Oversee shippers ensuring they are current on knowledge of regulations
- Assist receivers during busy or down times
3
Responsibilities For Regulatory Coordinator, Immuno Resume
- Utilizes current knowledge of GCP guidelines including protection of human subjects and regulations relevant to the performance and conduct of clinical trials
- Have a Cosmetics relevant education
- Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc
- Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third party auditors
- Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC QACT, Industry Sponsors, and third party auditors
- Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare
- Coordinating/facilitating the communication between businesses, audit teams and regulatory examiners in response to regulatory examiners’ questions on businesses responses or CAPs
- Processes regulatory document signature request through electronic signature platform
4
Responsibilities For Cancer Clinical Trials Regulatory Coordinator Resume
- Provide site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- Establishes and maintains a document management system for regulatory paper and electronic files
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
- Triages site requests for regulatory support and identifies correct pathway for issue resolution
- Attends network meetings, conference calls and monthly staff meetings as appropriate
- Assist with responses to regulatory requests
- Assist with tariff analysis and subsequent updates
- Support continuous process improvement activities through engagement of management and staff, and
- Assists with the maintaining, implementation, verification and validation of the Company’s Food Safety Plan to ensure compliance to the Food Safety Modernization Act’s regulations applicable to food manufacturers.Provides back-up support for other Preventive Controls Qualified Individuals
5
Responsibilities For Clinical Regulatory Coordinator / Specialist Resume
- Assists with the Company’s Corrective and Preventive Action Program.Includes assisting with root cause investigation, corrective/preventive action implementation and verification of the implemented action(s)
- Participates in company-wide regulatory, third-party and customer audits designated for the evaluation of Blue Diamond’s Preventive Controls, Food Safety, Food Security and Food Quality systems
- Assists with the Company’s pasteurization program to ensure adherence to the Almond Industry Pasteurization Rule; provides support to pasteurization validation studies
- Assists with the implementing, maintaining, verifying and validating of the Company’s SQF System; includes HACCP, Food Safety, Food Security and Food Quality programs
- Handle and administer narcotics and investigational drugs as needed
- Preparation and submission of protocol amendments, continuations, adverse events, and document addendums
6
Responsibilities For Internal Audit Regulatory Coordinator Internal Audit GF Resume
- Assistance with FDA and NCI submissions in collaboration with other City of Hope departments and Regulatory Affairs Offices
- Coordinates research projects and activities. Oversees day-to-day clinical research to guarantee the effective follow-through of study protocols and identified goals
- Collaborates with the project PIs to identify research project goals, assess protocol for clarity and subject safety, review inclusion/exclusion criteria, and then designs a system to accomplish these goals within study time frame and budget constraints
- Meets often with PIs, managers, and other research personnel to update overall study progress and make modifications as needed
- Designs documents, devices, tools, and educational programs and systems to ensure proper patient capture and facilitate accurate data collection
- Obtains informed consent, medical history and demographics; documents and maintains historical data, status reports, progress notes, and subject logs
- Performs other necessary research support functions as assigned by PI, manager, clinical research coordinator, or division chief
- A demonstrable ability to work well under pressure in a fast-paced environment and meet targets
- Facilitates and coordinates all aspects of IRB submissions. This includes evaluating protocol changes and incorporating those changes into the informed consent form in language understandable to the participant as required by the specific revisions made to the research protocol
7
Responsibilities For Regulatory Coordinator Senior Resume
- Diligently follow-up on quality information needed from suppliers (starting date/ finish date etc..)
- Propose suggestions for changes and improvements to existing/new processes and how to implement them
- Present an aggregate view of testing results to development team on a monthly basis
- Develop meeting agendas for quality touchbase with suppliers
- Learn the product development process with the intent to support day-to-day quality assurance/ quality control management
- Facilitate organization of supplier audits (social and GMP) with third party companies as needed
8
Responsibilities For Audit & Regulatory Coordinator Resume
- Facilitate organization of quality control with third party companies as needed
- Manage consumer testing with third party laboratories: send test product to labs, collaborate with marketing team to build questionnaire and determine testing specifications (questionnaire, panel selection criteria), communicate with the laboratories as needed
- Collaborate closely with suppliers and cross functional teams to ensure key dates are followed and milestones met
- Investigate internal/external quality issues, propose, initiate and follow-up corrective actions
- Review online ratings & reviews from sephora.com, report and investigate critical quality concerns / adverse experiences / functional problems to identify root cause and propose corrective action
- Track and organize quality retains
- Update standard development forms with all the information related to quality
- Assist supervisor with any other quality assurance activities, as needed
9
Responsibilities For Compliance Regulatory Coordinator Resume
- Passion and excitement for the beauty category, awareness of competitive landscape
- Flexible and agile with constant changes and time restraints
- Team oriented and able to work successfully with any personality type
- Independently recognizes, tracks and reports increased risks to participants on clinical studies
- Prepares, submits and maintains IRB, FDA, NCI, NIH, and/or other regulatory documents and research correspondence for all investigator-initiated, cooperative group and industry sponsored clinical studies
10
Responsibilities For HR Regulatory Coordinator Resume
- Recommends and implements changes in process and policy issues and provides guidance on meeting regulatory requirements
- Coordinates with investigator or study sponsor to ensure all regulatory activities are appropriately maintained and completed
- Contributes to developing educational materials on regulatory processes and requirements for the community and other research professionals regarding studies and related research issues
- Coordinates with physicians to provide information on available or competing research protocols and assist in their development and submission of investigator initiated clinical studies to appropriate regulatory review committees (CCIC, IRB, FDA)
- Develops and maintains regulatory databases to ensure appropriate regulatory procedures are tracked and monitored
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