Clinical Research Coordinator- Neuropharmacology

Dent Neurologic Group LLP•Amherst, NY

11d•Onsite

About The Position

The Clinical Research Coordinator plans, organizes, and implements human-subject research for the Dent Neurosciences Research Center (DNRC) according to study protocols. DNRC is a not-for-profit affiliate of DENT focused on outcomes research and education, developing comprehensive, clinically relevant, and cost-effective solutions to neurological problems in the community. The role supports study recruitment, subject screening and education, protocol procedures, data collection, study medication management, regulatory compliance, and laboratory activities. The coordinator works with investigators, patients, study staff, sponsors, and medical departments. The position is fully on-site in Amherst, New York, Monday through Friday, 8:00 a.m. to 4:30 p.m., for 40 hours per week. It may involve moderate physical activity, occasional movement of supplies or equipment, driving between offices, and periodic travel within the United States for investigator meetings and conferences.

Requirements

Bachelor's degree or equivalent training is preferred.
Prior clinical research experience is preferred but not required.
Personnel drawing blood must be credentialed under the Dent phlebotomy protocol.
Personnel handling, packaging, or shipping hazardous goods must become IATA certified.
All personnel must receive CITI, GCP, and NIH training.
Strong interpersonal and communication skills.
Excellent organizational skills.
Problem-solving skills.
Computer skills.
Ability to manage multiple projects at different stages.
Laboratory skills, particularly pipetting.
Ability to communicate verbally, by telephone, and in writing, including giving or receiving information and instructing others.

Nice To Haves

Prior clinical research experience.
Bachelor's degree or equivalent training.
CPR certification.

Responsibilities

Screen potential study subjects for protocol eligibility using inclusion and exclusion criteria.
Explain study requirements, medications, potential side effects, medical care, testing procedures, and study findings to subjects; refer questions to the investigator when appropriate.
Interpret patient medical records and review laboratory or diagnostic tests, referring to the investigator when appropriate.
Identify potential study candidates through appointment lists, medical records, and general advertising.
Perform and document delegated study procedures, including interviews, vital signs, ECGs, psychometric testing, and other protocol tasks.
Update study database programs, including patient randomization, correspondence, and hotline reports, where appropriate.
Collect and document research data; create and maintain case report forms, summary sheets, and data-labeling systems.
Communicate with sponsor study monitors about data collection and study progress.
Coordinate with medical departments to collect data such as MRI films, CT scans, and radiographs.
Arrange study-subject visits, staff schedules, appointments, and study locations.
Manage the dispensing and return of study medication in accordance with FDA guidelines.
Organize paperwork for volunteer payments, including applicable tax forms and participation and eligibility documents.
Ship, receive, and inventory study supplies, including drugs; store supplies, drugs, and biologic fluids according to protocol requirements and maintain calibration and temperature requirements.
Assist with updating standard operating procedures and archive study documents according to contracts and SOPs.
Maintain a database of potential and former study volunteers, including health status and contact information.
Perform diagnostic testing such as ECGs and draw blood when trained or certified.
Maintain regulatory documents for human-subject compliance, including IRB communications, and prepare continuing review documents for IRB submission.
Process patient samples, communicate about and maintain supply inventory when applicable, and conduct and maintain laboratory quality controls weekly to monthly depending on scheduling and staffing.