Senior Clinical Research Coordinator
5 days ago
Sr. Clinical Research Coordinator
Job Summary:
We are seeking a highly experienced Sr. Clinical Research Coordinator to join our team at Actalent. The successful candidate will be responsible for managing and overseeing the day-to-day operations in the administration of clinical trial activities at the site-level.
Key Responsibilities:
- Interface with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.
- Develop and maintain standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
- Contribute to the training of clinical trial staff and ensure compliance with the operational requirements of the clinical trial.
- Act as the primary point of contact for participants, keeping them informed on the study progress and facilitating involvement of other study team members as needed.
- Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s).
- Solicit and record information regarding safety events and prepare safety event documentation for review by the Principal Investigator.
- Collect, document, and report accurate and timely data in both Sponsor and Walgreens databases.
- Support the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.
- Communicate and collaborate specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
Requirements:
- 5-10 years of experience coordinating Clinical Research trials.
- Phlebotomy proficiency.
- Knowledge of regulatory affairs.
- Excellent patient/customer service skills.
What We Offer:
- A contract position with a duration of 12 months.
- Possibility for extension or more.
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.
We are an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
If you would like to request a reasonable accommodation, please email us for other accommodation options.
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