Clinical Research Coordinator- Neuropharmacology

Dent Neurologic Group LLP•Town of Amherst, NY

12d•$22 - $28•Onsite

About The Position

The Clinical Research Coordinator plans, organizes, and implements human-subject research for the Dent Neurosciences Research Center according to research protocols. The DNRC is a not-for-profit affiliate of DENT focused on outcomes research and education, and develops clinically relevant, cost-effective solutions to neurological problems in the community. The coordinator screens and informs potential study subjects, performs and documents delegated protocol procedures, collects and manages research data, coordinates study visits and supplies, and supports regulatory compliance and laboratory activities. The position is fully on-site in Amherst, New York, with a Monday–Friday schedule of eight hours per day, 8:00 a.m.–4:30 p.m. (40 hours per week). The role involves occasional movement of supplies or equipment, travel 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 Dent's phlebotomy protocol.
Personnel handling, packaging, or shipping hazardous goods must obtain IATA certification.
Personnel must complete CITI, GCP, and NIH training.
Strong interpersonal and communication skills, including verbal, telephone, and written communication.
Excellent organizational skills.
Problem-solving skills.
Computer skills.
Ability to manage multiple projects at different stages.
Laboratory skills, particularly pipetting.
Moderate physical activity, including occasional movement of study supplies or equipment.
Ability to travel between offices and periodically travel throughout the United States for investigator meetings and conferences.

Nice To Haves

CPR certification is preferred.
Bachelor's degree or equivalent training is preferred.
Prior clinical research experience is preferred but not required.

Responsibilities

Screen potential study subjects for protocol entry using inclusion and exclusion criteria.
Explain study requirements, medications, potential side effects, medical care, testing procedures, and study findings to subjects, referring questions to the investigator when appropriate.
Interpret patient medical records and review laboratory or diagnostic tests, referring to the investigator when appropriate.
Identify study candidates through appointment lists, medical records, and general advertisements.
Perform and document delegated study procedures, including interviews, vital signs, ECGs, psychometric testing, and other protocol tasks.
Update study computer databases, 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.
Implement systems for dispensing and returning study medication in accordance with FDA guidelines; prepare volunteer payment paperwork where applicable.
Ship, receive, and maintain inventory of study supplies, including drugs.
Store study supplies, drugs, and biologic fluids according to protocol requirements, including calibration and temperature requirements.
Assist with updating standard operating procedures and archive study documents in accordance with contracts and SOPs.
Maintain a database of potential and former study volunteers, including health 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, maintain supply inventory as applicable, and conduct laboratory quality controls weekly to monthly depending on scheduling and staffing.