CLINICAL TRIALS STUDY COORDINATOR

Job Description

Job Description

We are seeking a Full Time on-site Clinical Trials Study Coordinator.

Summary :

The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the vision and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned trials. The CRC follows study specific protocol guideline and communicates and interacts with Investigators, clinic staff, CROs and Sponsors to effectively perform clinical research and coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, state and federal regulations.

Primary Responsibilities :

• 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 Lead, Manager, Principal or Sub-Investigator, and other members of the study team.
• Collect initial subject health and demographic information by interviewing subjects and 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 and recruitment team, Sponsor and / or CRO, Monitor(s) and Auditors, if applicable.
• Perform clinical tasks including, but not limited to : vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging.
• Maintain timely internal source documentation as well as sponsor-required information.
• Maintain timely EDC data entry and query resolution.
• Maintain timely CTMS data entry of patient visits and study information.
• Complete Verification of subjects before consenting.
• Report hospital census data, if applicable.
• 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.
• Perform Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed.

Recruitment Responsibilities :

Secondary Responsibilities :

Maintains Quality Service and Departmental Standards by

Contributes to team effort by

Maintains Technical and Industry Knowledge by

Skills And Qualifications :

CCRC or CCRP certification preferred

Experience :

At least 2 years of experience as a CRC in clinical research or relevant clinical role

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.