Kelly Science and Clinical FSP is currently seeking a Clinical Research Associate for a long-term engagement in the US with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
This role is hybrid in Irvine, CA onsite Monday, Wednesday and every other Friday Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.
Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.
Key Job Activities: Clinical Study Site Management Tasks
- Verify safety and well being of study subjects are maintained for assigned study sites.
- Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
- Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
- Accountable for study site performance, and providing high quality data according to overall project timeline.
- Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
- Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
- Responsible for supporting patient recruitment and retention activities.
- Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
- Assists with internal communication of important clinical data and events.
- Support organization of Investigator and other study training meetings, if required.
- Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
- Understand business value of clinical projects and balances overall business objectives and functional needs.
- May be involved in other tasks to support Clinical Operations and Operating Company as needed.
- Support the implementation of new clinical systems/processes.
- Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
Administrative Tasks
- Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- May be asked to provide additional support to Clinical Operations staff, as needed.
Education - A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
Experience - Typically requires Bachelors degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.
- Previous clinical research experience required.
- Previous medical device monitoring or equivalent experience required.
- Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
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