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Clinical Research Coordinator - United States  

Bio Clinica (company)


Posted on : 08 June 2017

Project Description

Job Description 
  • 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. 

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 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.  

Required Skills          
  • 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   

Required Experience 
  • 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.