Senior / Clinical Research Associate Resume Sample
Leonardo Swift
1200 Doyle Land,
Los Angeles,
CA
+1 (555) 854 6768
Work Experience
Senior / Clinical Research Associate
08/2015
-
PRESENT
New York, NY
- No relocation/ local candidates only
- Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
- Serve as key contact to assigned clinical sites throughout the study process
- Is accountable for achieving and reporting on agreed clinical milestones
- Supports study team in the interactions with Ethics Committees and Competent Authorities
- Providing site and Edwards personnel training including reparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
- Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
- BS/BA (or equivalent) in one of the life sciences
Senior.clinical Research Associate
10/2012
-
06/2015
Phoenix, AZ
- Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Position filled at level commensurate with experience
- No relocation available- local area candidates only
- Trains site staff on the EDC system and verifies site computer system
- Subject Safety- Perform safety reviews/SAE reconciliations; monitor the informed consent process; ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in Novella SOPs by using approved Novella/sponsor templates and reports
- Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items
- Assists with, and attends, Investigator Meetings for assigned studies
- Ensures all study deliverables are completed per Novella and study timelines
Senior Clinical Research Associate Western
01/2007
-
06/2012
Los Angeles, CA
- Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs
- Serves as mentor for junior CRAs and those new to the company and/or study
- BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) or equivalent amount of education
- Computer literacy and knowledge of electronic data capture required
- Create master tracker(s) to house information generated from various reports such as
- Provides ongoing assessment of resource needs and in allocating resources in alignment with AbbVie’s research goals, priorities and specific study timelines
- Subject Safety - Perform safety reviews/SAE reconciliations; monitor the informed consent process; ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues - as appropriate
Education
University of Phoenix - Springfield Campus
2003 - 2007
Science's Degree in Health Care
Professional Skills
- Demonstrated clinical trial monitoring skills
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
- Excellent English, French and Dutch language skills
- Excellent standard of verbal and written communication skills in English
- At least 18 months of on-site monitoring experience, ideally including experience monitoring clinical trials in Australia or New Zealand
- At least 12 months of on-site monitoring experience, ideally including experience monitoring clinical trials in Australia or New Zealand
- On-site monitoring experience, ideally including experience monitoring clinical trials in Australia or New Zealand
How to write Senior / Clinical Research Associate Resume
Senior / Clinical Research Associate role is responsible for research, clinical, training, health, database, oncology, reporting, assembly, travel, events.
To write great resume for senior / clinical research associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior / Clinical Research Associate Resume
The section contact information is important in your senior / clinical research associate 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 Senior / Clinical Research Associate Resume
The section work experience is an essential part of your senior / clinical research associate 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 senior / clinical research associate responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior / clinical research associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior / Clinical Research Associate resume experience can include:
- Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience
- Independent monitoring experience in clinical development phase II-IV
- On-site monitoring experience
- At least two years of on-site monitoring experience
- On-site monitoring experience
- Experience and high level of competency as a Clinical Research Associate
Education on a Senior / Clinical Research Associate Resume
Make sure to make education a priority on your senior / clinical research associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior / clinical research associate 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 Senior / Clinical Research Associate Resume
When listing skills on your senior / clinical research associate 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 senior / clinical research associate skills:
- Experience in Trauma, brain injury and big surgeries required for candidates with ICU experience
- Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology
- Experience in monitoring and/or coordinating clinical trials required
- On-site monitoring experience in Oncology
- Monitoring experience in interventional studies with a CRO, pharmaceutical or biotech company
- Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and GCP/ICH guidelines
List of Typical Skills For a Senior / Clinical Research Associate Resume
1
Skills For Senior.clinical Research Associate Resume
- Drive an automobile and have a valid driver’s license
- Solid regulatory and ethics knowledge in South Africa
- Experience as a CRA from a Pharmaceutical, Biotech, or CRO company
- Experience with pre-study visits and start-up activities
- Attending Co-Monitoring Visits with CRO team
- Act as a mentor for new clinical staff for clinical staff including conducting co-monitoring and training visits
2
Skills For UK Senior Clinical Research Associate Resume
- Track and provide study-specific information and updates to internal and external teams utilizing databases, spreadsheet and other tools
- Review of Monitoring Reports and monthly metric reports from CRO
- Uses Scientific/Technical/ Functional Expertise
- Fluency in English language (written and verbal) is required as well as Hebrew
- In-depth knowledge of ICH-GCP, EU and FDA requirements
- The ability to work independently in a home based environment, with minimal supervision
- Interact with all levels of staff to coordinate/execute study activities
- At least 18 months of on-site monitoring experience within a pharmaceutical company or CRO, ideally including experience monitoring clinical trials in Australia or New Zealand
- A suitable home office set-up and the ability to work well with minimal day to day supervision
3
Skills For Senior Clinical Research Associate Western Resume
- Fluency in English language (written and verbal) is required
- Willingness and ability to travel across South Africa (and Africa if on non-commercial work)
- CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA
- Fluency in English and Finnish, both written and spoken
- Determine protocol and regulatory compliance on the sites
- Maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
4
Skills For Senior Clinical Research Associate UBC Resume
- Conducts periodic site file audits to ensure compliance with GCPs and
- Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
- Perform pre-study (evaluation) visits at sites in Sweden and Norway
- Act as a key site contact on a country level for start-up related activities and provide oversight for projects
- Prepare regulatory compliance review packages as needed
- Support the coordination of feasibility activities in accordance with guidelines
- Manage specific study responsibilities as assigned by the Director/Sr. Director of Clinical Operations Department
5
Skills For Senior Clinical Research Associate, Oncology Resume
- Provide clinical study updates/information to internal departments/teams
- Work closely with Clinical Trial Manager to ensure adequate and appropriate supplies of Investigational Product (IP) are available
- Assist in the development, assembly and distribution of template informed consent, study documents, manuals and tools
- Maintains and manages internal clinical trial files and documents on electronic study files
- Perform pre-study (evaluation) visits at sites in Finland
6
Skills For Senior Clinical Research Associate Ontario Territory Resume
- Support the coordination of feasibility activities in accordance with guidelines: Serve as the local expert regarding site capacity and expertise and work with key local personnel to gather knowledge base and recommend additional sites
- Ensure an efficient, effective plan is in place for site contact and follow up
- Experience of contracts negotiation would also be an advantage
- Develop site lists to ensure the site list is reflective of the defined site profile
- Be responsible for collection and delivery of associated documents from investigators and site personnel
- Ensure current investigator and site staff contact details are appropriately maintained in PPD systems
7
Skills For Senior Clinical Research Associate Quebec & Eastern Territory Resume
- Provide local regulatory strategy and advice
- Act as a key contact on a country level for all submission related activities and provide oversight for projects in start up
- Coordinate, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines
- Prepare regulatory compliance review packages
- Prepares Written Communications
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