The Clinical Research Coordinator, under the guidance of the department manager, and each clinical trial's Principal Investigator, is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines and ICH guidelines as applicable. Facilitates multidisciplinary internally- and externally-sponsored research. Including patient contact for enrollment, treatment and follow-up activities.
DUTIES AND RESPONSIBILITIES:
A Clinical Research Coordinator's responsibilities include, but are not limited to, the following:
- Always represents company in a professional manner (verbal, written and in appearance) when interacting with sponsors, subjects, outside vendors and fellow employees.
- Reviews study protocol and Investigator's Brochure.
- Attends the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits by Monitors or Sponsor representatives.
- Establishes study regulatory document binder to maintain complete and accurate records of all Sponsor, site, CRO, IRB/IEC correspondence and regulatory documents pertaining to the study.
- Performs quality checks on source documents specific to the study.
- Reviews approved regulatory documents from the IRB/IEC.
- Arranges for procedures performed by external vendors that are necessary to the conduct of the study.
- Attends in-house protocol meeting to review study-related procedures, staffing and visit flow.
- Schedules medical coverage for physicals, dosing, etc.
- Coordinates the trial from phone screening to randomization to study completion.
- Uses experience to schedule study procedures so they are efficient and timely for all involved while maintaining study integrity.
- Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose.
- Maintains and documents communication with Sponsor or Sponsor representative(s) throughout the clinical trial.
- Responsible for giving subject instructions at check-in and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
- Ensures randomization procedures are completed per study requirement.
- Obtains and documents adverse event data on appropriate forms.
- Assures quality and completeness of source documents and Case Report Forms (CRFs) collected during the course of the study.
- Enters data into CRFs using 100% source documentation verification.
- Files interval (interim), annual reports, and/or final reports to the IRB/IEC, IND safety reports and other pertinent information throughout conduct of study.
- Assists with monitoring visits on site and available during visits for correction, questions, etc.
- After close-out visit has been conducted, prepares study documents for archiving, according to timelines.
- Reviews and signs final study reports.
- Responsible for completing all necessary training for the position, including DOPs and SOPs.
- Helps train new Coordinators, Assistant Clinical Research Coordinators, and Research Associates by serving as a mentor.
SCHEDULED HOURS PER WEEK:
Full Time-40 hours
EDUCATION AND EXPERIENCE:
Bachelor's Degree (preferably in the field of Life Sciences or Health) with clinical research experience.
2+ years of clinical research experience
Proven track record in successful subject enrollment
ACRP or SOCRA certification
Indeed - 7 months ago