POSITIONS AVAILABLE

Job Title: Clinical Research Coordinator

Position Summary:

The Clinical Research Coordinator (CRC) is responsible for the ethical and accurate coordination and administration of clinical trials under the direction of the Site Manager, the Principal Investigator and the Medical Director.  The CRC will perform diverse administrative and clinical duties requiring analysis, sound judgement, and a high level of knowledge of study specific protocols.

Duties and Responsibilities:

• Maintain familiarity with FDA regulations for clinical research
• Administratively and clinically manage approximately six to ten clinical trials
• Adhere to company Standard Operating Procedures, Good Clinical Practice and study protocols
• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
• Obtain Informed Consent from study participants and verify documentation
• Screen potential study participants for inclusion/exclusion criteria
• Schedule and conduct study visits per protocol requirements, including but not limited to the following:
  • Dispense study medication in a professional and accountable manner
  • Collect, process, and ship blood/urine specimens
  • Perform ECGs, obtain vital signs
  • Administer questionnaires/diaries

• Complete source documentation and maintain timely completion of case report forms
• Ensure prompt reporting of events to sponsor and IRB
• Assess participant’s condition and report any significant variations from baseline measurements to Principal Investigator
• Submit timely patient reimbursement requests to financial team for patient’s participation in protocol
• Ensure the filing and maintenance of all regulatory documents
• Schedule and prepare for monitoring visits
• Maintain communication with Principal Investigator, Sub Investigators, Assistants, sponsors, IRB

Education and Experience:

• Bachelor’s degree preferred
• Associates degree in nursing or related field required
• Two years in a related healthcare position

Qualifications and Requirements:

• Pleasant, outgoing, and mature.  Good communication and time management skills.  Attention to detail.  Self-disciplined and motivated.  Diligent and persistent.
• High level of integrity and accountability
• Ability to function effectively and positively in a team environment
• Must have the ability to establish and maintain good working rapport with study patients, physicians, investigators, referring physicians, research staff and clinic
• Must exhibit accurate, complete, legible and timely use of communication methods
• Familiar with medical terminology
• BCLS training required
• ACLS training required
• Recommended to sit for Certified Clinical Research Coordinator certification after two years’ experience