Clinical Research Coordinator - United States
Bio Clinica (company)
The Clinical Research Coordinator I is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the philosophy and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned research projects. The CRC follows study-specific protocol guidelines and communicates and interacts with Investigators, clinic staff, sponsoring agencies, and others to effectively perform clinical research and to coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies and SOPs, as well as all applicable local, state, and federal regulations. Professionals in this role actively participate in outstanding customer service and accept responsibility for developing and maintaining mutually respectful relationships.
- Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP, and protocol guidelines.
- Identify potential problems or inconsistencies and take action as appropriate.
- Articulate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator, and other members of the study team.
- Collect initial subject health and demographic information by interviewing subjects and by accessing other appropriate sources.
- Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator.
- Ensure a flow of communication including telephone conferences between subject, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor.
- Perform clinical tasks including, but not limited to; vital signs, height and weight, ECG, phlebotomy, and specimen packaging.
- Maintain timely internal source documentation as well as sponsor-required information.
- Dispense and maintain accurate records of investigational and study product.
- Educate subject and family members regarding specific studies and clinical drug trials in general.
- Complete all monitor and sponsor queries in a timely manner.
- Provide educational in-services for third party vendors providing protocol specific care to subjects.
- Maintain reasonably regular, punctual attendance consistent with company policy, the ADA, FMLA, and other federal, state, and local standards.
- Provide appropriate community resource referrals to subjects, caretakers, and family members at conclusion of subject’s participation in study, as appropriate.
- Maintain compliance with all company policies and procedures.
- Detail Oriented
- Strong critical thinking skills
- Strong ability to multi-task
- Strong computer skills
- Ability to support and demonstrate the mission and goals of the company
- Ability to communicate clearly and effectively (written and oral)
- Excellent interpersonal and customer service skills
- Bachelor’s degree in a health-related field required.
- At least one year experience in clinical research or a relevant clinical role.
- Knowledge of medical terminology and clinical practices.
- BLS Healthcare Provider required.
- LPN, RN, or other medical licensure or certification preferred.