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Clinical Research Coordinator
1 month ago
We are seeking a highly skilled and motivated Clinical Research Coordinator to join our team at Flourish Research. As a Clinical Research Coordinator, you will play a critical role in the success of our clinical trials by coordinating various activities and performing duties related to the start-up, conduct, and close-out phases of clinical pharmaceutical and device research protocols.
Key Responsibilities:- Coordinate patient visits and procedures according to protocol requirements and timelines.
- Document patient assessments, observations, test results, and other study-related information per federal regulations, protocol requirements, and Good Clinical Practices (GCPs).
- Obtain patient informed consent according to federal regulations, GCPs, and Institutional Review Board (IRB) requirements.
- Recruit qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor's timeline while following regulations and rules governing medical ethics, IRB, GCP, and ICH guidelines.
- Complete all required training in a timely manner.
- Schedule and conduct patient visits according to protocol requirements and timelines.
- Maintain accurate and complete written source documentation of patient visits and protocol-related activities.
- Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets generated by the sponsor.
- Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with Flourish Research, between Flourish and sponsors, and between Flourish and other entities, as well as HIPAA regulations.
- Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
- Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to supervisor, Principal Investigator, and/or Sub-Investigator.
- Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study.
- Maintain ongoing communication with Clinical Team Manager, Principal Investigator, Sub-Investigators, and other persons assisting with the trial and documenting these communications according to protocol requirements and Flourish policies.
- Attend required training courses/conferences to stay abreast of current and changing federal regulations and Flourish policies.
- Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
- Attend Investigator Meetings and/or other trainings as directed.
- Perform all study-related duties in a time- and cost-effective manner in adherence with Flourish policies.
- Perform all duties in a safe and prudent manner.
- Perform other duties as assigned.
- Represent Flourish Research in a professional and courteous manner (verbal, written, and in appearance) when interacting with Flourish staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician's offices.
- Additional duties as assigned by management.
- Fluency in Haitian Creole is a requirement for this position.
- Bachelor's degree preferred; however, is not required.
- Preferably a minimum of 2 years' experience as a CRC, plus 1-3+ years' minimum experience within the field of clinical research or biological research.
- Given this is a start-up site, the CRC is fully responsible for consenting patients, taking vitals, performing ECGs, and other trial-related duties.
- The ability to perform phlebotomy and conduct laboratory processing procedures is required.
- $55,000 - $65,000 a year. This position is paid hourly.
- Paid Time Off
- 8 Paid holidays, Including 2 Floating Holidays
- 401K plan: 4% Match
- Employee Review and Performance Program
- Tuition Reimbursement Policy
- Employee Referral Bonus
- Supplemental Parental Leave
- Be part of a mission-driven organization dedicated to advancing clinical research.
- Opportunity to lead and grow a start-up site with significant impact.
- Collaborative and supportive work environment.
Please submit your application via LinkedIn or send a resume and salary requirements to: executivesearch@highlandperformancesolutions.com
