Coordinator in Training

Position Summary

The Clinical Research Coordinator (CRC) in Training works directly under a Clinical Research Coordinator and is responsible for the ethical and accurate coordination and administration of clinical trials under the direction of the Clinical Research Coordinator, Site Manager, the Principal Investigator and the Medical Director. The CRC in Training will perform diverse administrative and clinical duties requiring analysis, sound judgement, and a high level of knowledge of study specific protocols. A coordinator new to research should be considered a Research Coordinator in Training up to their first two years of experience.

Duties and Responsibilities

• Obtain familiarity with FDA regulations for clinical research
• Administratively and clinically manage protocols under supervision of CRC
• 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
• 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 preferred
• 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.
• Ability to function effectively and positively in a team environment
• High level of integrity and accountability
• 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
• BLS training required
• Recommended to sit for Certified Clinical Research Coordinator certification after two years' experience