Clinical Research Coordinator

General Summary:

The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Principal Investigator. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.

Essential Job Responsibilities:

• Maintains proper skills to comply with the protocol, federal regulatory requirements, internal SOP’s.
• Administratively and clinically manage clinical trials.
• Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
• Performs continuous reviews of the inclusion and exclusion criteria for each participant during the screening period.
• Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
• Builds strong relationships with Investigators and provides ongoing communication about trial status and participants.
• Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
• Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor.
• Addresses all queries or data clarifications within 48 hours of receipt.
• Adhere to Research SOP’s.
• Adhere to Good Clinical Practices and the study protocols.
• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
• Discuss study protocols with patients and verify the informed consent documentation.
• Provide patient with written communication of their participation (i.e. copy of the signed informed consent).
• Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient.
• Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study.
• Dispense study medication in a professional and accountable manner following protocol requirements.
• Collect, process, and ship blood/urine specimens at scheduled patient visits.
• Perform ECG and obtain vital signs of patients.
• Schedule all patient research visits and procedures consistent with protocol requirements.
• Administer questionnaires/diaries per protocol.
• Screen all laboratory results when received and follow protocol procedure regarding abnormal results.
• Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder.
• Submit patient reimbursement requests at the conclusion of patient’s participation in protocol.
• Ensure the filing and maintenance of all regulatory documents.
• Schedule monitor visits and set up for monitoring visits prior to monitor’s arrival.
• Other duties as assigned.

Education & Experience:

• Minimum three years of experience as a Clinical Research Coordinator required.
• Preferred Associates Degree in Nursing or RN.

Qualifications & Requirements:

• Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations.
• Able to effectively present information and respond to questions from physicians, staff and patients.
• Knowledge of Good Clinical Practices and the regulations necessary for the protection of human subjects and the conduct of clinical research required. Knowledge of the International Air Transport Association (IATA) regulations for the transportation of Dangerous Goods also necessary.
• Knowledge of EMR systems and familiarity with MS Office programs.
• Able to function effectively in a team setting.
• Needs to demonstrate consistent professional conduct and meticulous attention to detail.
• Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals.
• Limited travel may be required for visits with study sponsors.
• Current CPR certificate.

Equipment Operated:

Standard equipment and supplies including thermometer and syringes. May involve use of assistive devices such as walkers, wheelchairs, ventilators, pulse oximetry units, and oxygen tanks. Requires use of computer.

Work Environment:

Medical exam/treatment rooms and medical offices. Controlled lighting, acoustics, air quality, and temperature settings. Environmental hazards may be unpredictable including exposure to communicable diseases and biohazards.

Mental/Physical Requirements:

Involves standing, walking, bending, grasping, manipulating, and squatting. Occasional need to lift patient during transfer/turn process with or without assistance. Stress can be triggered by workload and complex cases.

Pay is dependent upon experience.

Pay: $26.00 - $32.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Work Location: In person