Clinical Research Coordinator - United States
Want to know company name or location? Company managed [?]
- The Clinical Research Coordinator (CRC) 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.
- Applicants that don’t meet 100% of the above qualifications but who have a combination of related education and applicable experience may be considered upon approval.