senior clinical research associate contractor resume example with 10+ years of experience
JessicaClaire
, , 100 Montgomery St. 10th Floor(555) 432-1000, resumesample@example.com
Summary
Accomplished Clinical Research Associate with 18 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Skills
Database locking
Patient recruitment
Completing regulatory documents
Coordinating site operations
Developing study tools
Meeting reporting
Investigator meetings
Trial methodologies
Subject tracking tools
Drug development
Project monitoring
Trial study center set up
Report writing
Pre-study visits
Protocol adherence
Educational activities
Medication dispensing
Trial management
Good Clinical Practices
Study protocols
Schedule coordination
Medicaid statutes and regulations
Site management
Experience
07/2021 to 01/2023Senior Clinical Research Associate (Contractor)Johnson & Johnson | Alpharetta, GA,
Monitored collection, accuracy and integrity of regulatory documents in site binder
Contributed to departmental quality control program by setting project schedules and supporting monitoring with members team
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files
Obtained site approvals and gathered all documentation prior to beginning studies to meet rigorous regulatory standards
Worked closely with data management and site teams to resolve discrepancies
Maintained site monitoring schedules and served as principal point of contact with sites
Provided clinicians with information on how to properly conduct trials
Documented and reported clinical study progress and discussed potential opportunities and risks with respective project team members
Checked drug storage procedures for compliance with protocols and SOP requirements
Reviewed participant eligibility and documentation of consent
Mentored team members to deliver successful studies
Conducted initiation, monitoring and closeout visits
Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures (SOPs), good clinical practices (GCPs) and local requirements
Liaised with vendors for protocol adherence and checked clinical supplies at investigational sites
03/2013 to 12/2017Clinical Research CoordinatorNes Associates | City, STATE,
Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols
Screened patient records, databases and physician referrals to identify prospective candidates for research studies
Collected, evaluated and modeled collected data
Maintained compliance with protocols covering patient care and clinical trial operations
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
Gathered, processed and shipped lab specimens
Followed informed consent processes and maintained records
Collected data and followed research protocols, operations manuals and case report form requirements
Coordinated clinical trials focused on disorders such as Diskynesia, and Parkinson Disease
Monitored unit budget to ensure financial objectives were met
Supervised students when administering medications to ensure patient safety
Improved delivery of patient care through reviewing and implementing improvements to clinical approaches
Confirmed accurate completion of forms and reports for admission, transfer and/or discharge of each resident
01/2008 to 03/2012Clinical Research Assistant/Medical AssistantFlorida Medical Center -Dr Gershenbaum | City, STATE,
Recruiting subject, Screening and scheduling subjects, Getting voluntary subject consent, Teaching subjects about protocol expectations for them, Performing study/protocol procedures in a detailed, accurate mJessicaer, Maintaining study files, Tracking and maintaining the study budget and payments, including invoicing the sponsor for completed work, Tracking subjects, avoiding lost-to-follow-up, Documenting an adverse event, including: describing the event, severity and frequency, treatment, resolution, Processing and shipping lab work, ECG, Venipuncture, IV
Assisted with research protocol development
Demonstrated advanced knowledge of federal regulatory compliance guidelines
Ensured adherence to FDA guidelines
Educated patients regarding all facets of clinical study participation
Education and Training
Expected in 05/2000 to to Bachelor of Science | Health Care Administration And PlanningTennessee State University, Nashville, GPA:
Tennessee State University
May 2000
Bachelor of Science (Health Care Administration and Planning)
GPA 3.25
Cum Laude
Certifications
LabCorp:Good Clinical Practice, ICH, Clinical Subject Research
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