Clinical Research Coordinator

JOB 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

• Send “All Users” email upon enrollment activation or enrollment closure
• Participate in recruitment planning meetings prior to study start
• Provide weekly updates to Active Studies Report
• Communicate all advertising needs to recruitment team
• Maintain weekly communication with recruitment team in order to maximize recruitment in all
• enrolling trials
• Communicate the need for study or company flyers

Secondary Responsibilities

• Maintains Quality Service and Departmental Standards by
• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Assisting in establishing and enforcing departmental standards
• Contributes to team effort by
• Working with internal staff to resolve issues
• Exploring new opportunities to add value to the organization and departmental processes
• Helping others at the site to achieve site goals
• Performing other duties as assigned
• Support the organization’s mission and goals
• Maintains Technical and Industry Knowledge by
• Attending and participating in applicable company-sponsored training
• Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings

Minimum Qualifications:

• At least 2 years of experience as a CRC in clinical research or relevant clinical role
• CCRC or CCRP certification preferred

Additional skill set:

• Strong motivational skills and abilities – promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain a professional and positive attitude
• Detail Oriented
• Strong critical thinking skills
• Strong ability to multi-task