Job Title: Sr. Clinical Research Coordinator
Job Description:
- 5-10 years of experience coordinating Clinical Research trials.
- Working to help enroll patients in clinical trials via pharmacy locations (5 days on-site).
- Must have phlebotomy proficiency.
- Must have knowledge of regulatory affairs—able to work independently as the primary/sole Clinical Research professional onsite.
- Excellent patient/customer service skills.
- Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants).
- Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.
- Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
- Contributes to the training of clinical trial staff and is accountable for compliance with the operational requirements of the clinical trial.
- Functions as participants' primary point of contact, keeping them informed on the study progress, and facilitates involvement of other study team members, as needed (e.g., notifying Principal Investigator of safety events).
- Manages participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s).
- Solicits and records information regarding safety events and prepares safety event documentation for review by the Principal Investigator.
- Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases.
- Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
Hard Skills: Clinical Research Coordinator, Phlebotomy, Vaccine
Job Type: This is a contract position with a duration of 12 Month(s) with the possibility for extension or more.
Please email your resume and 2-3 professional references to Claire: czbieraj@actalentservices.com for more information.
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