Preference will be given to nursing / medical background, but will consider science/biology background for experienced CRC. Fulltime as well as Contracting will be considered, just specify in your response. Relocation assistance available for the right candidate. Internal Medicine, Endocrinology, and Nephrology experience is strongly desirable. New nursing schools graduates (LPN/RN) who want to pursue a career in the Clinical Research are encouraged to apply. Foreign Medical Graduates will be considered. Part time hours is an option for local candidates
This will be filled at 2 levels, one as inexperienced CRC and one as an entry level CRC.
The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of the 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.
Primary Responsibilities "not exclusive"
Team Player is a must.
Critical/Clinical thinking & skills.
Detail oriented and
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.
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 organization and departmental processes
Helping others to achieve results
Performing other duties as assigned
- Nursing/Medical Background is highly desirable
- For the Experienced level, at least 3 years of clinical research experience is desirable.
- Experience is required for ;part time considerations.