Job Description

Clinical Research Coordinator

Job Duties:

Principal Duties and Responsibilities (The statements below are intended to describe the essential duties of the person or persons assigned to this job. They are not intended to be an exhaustive list of all job duties and responsibilities.)

• Responsible and accountable for assisting in the implementation of a research protocol, including; working with physicians and the research team to identify and recruit eligible research subjects.
• Verifies subject eligibility according to protocol-specific criteria. Obtain all necessary approvals and informed consent forms.
• Interfaces with study sponsor, monitor, and personnel.
• Assists Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Coordinates preparation of protocol applications for submission to the IRB, sponsor, regulatory authority, etc. Corresponds with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
• Organizes strategies for recruiting study participants, screens study participants for eligibility on the telephone, in the clinic and other settings as required.
• Follows individual study protocols. Completes informed consent procedures as assigned.
• Completes follow up with study participants in prescribed settings as required.
• Complies with all institutional policies and government regulations pertaining to
human subjects protections.
• Maintains regulatory binders, case report forms, source documents, and other study documents.
• Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB).
• Updates protocol and amendment changes.
• Corresponds with IRB and sponsors in a timely manner.
• Assess subject participation on a continuous basis in light of ethical considerations.
• Act as a liaison between the subject and other members of the team regarding the research protocol.
• Responsible for study data entry and completion of case report forms.
• Maintains accurate records of study activity and follow-up.
• Completes record abstraction of source documents, conducts required study measurements and completes study Case Report Forms in accordance with best practice methods.
• Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries.
• Medication accountability
• Perform vitals / Ability to perform phlebotomy or interest in learning the skill.
• May require the collection or processing of study specimens, delivery to appropriate labs or packaging and shipping to appropriate facilities.
• Organizes study procedures and schedules study participants for study visits.
• Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
• Performs work in conformance with established office policies and procedures and all federal and provincial regulations.
• Assists with ensuring subjects are compensated in a timely manner.
• Designs and maintains materials and databases such as excel that aid in the accurate conduct of the study.
• On-call/weekends may be required.
• Prepare summary reports and ongoing project evaluations for investigators.
• Attends applicable courses and meetings offered by Clinical Research Program.
• Works with study staff to prepare for monitoring and audits of the independent
monitor, sponsor and Food and Drug Administration (FDA).
• Works closely with others in the Clinical Research Program.
• Perform other duties as required.

Qualifications:
• Post-graduate degree in nursing, laboratory sciences, psychology, biology or chemistry is preferred.
• Prefer if Good Clinical Practice (GCP) training is completed, but is not necessary.
• Ability to travel to offsite locations (have a valid passport).
• Team player who would enjoy working with an energetic and diverse group of researchers on the both the scientific and clinical aspect but can work independently as well.
• Superb interpersonal skills for interaction with patients, nurses, physicians and sponsoring organization representatives.
• Excellent English communication skills (oral and written). Computer proficiency, including; ability to access, enter, and interpret computerized data/information.
• Excellent interpersonal skills; to be socially perceptive in accepting and relaying confidential information, communicating policies and procedures, and interact effectively with a variety of people.
• Organizational skills; to set priorities and efficiently complete assigned work. Attention to detail is a must.
• Courtesy, sensitivity, and clarity in communications with research subjects and family members is essential.