Clinical Research Coordinator

HealthAlliance of the Hudson Valley; New York (NY); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading health organization in New York is seeking a Clinical Research Coordinator to manage and coordinate clinical trials. You will work closely with principal investigators and ensure compliance with regulations while safeguarding patient welfare. Ideal candidates have a relevant bachelor's degree and experience in clinical research. This full-time role offers a supportive environment for professional growth.

Qualifications

• Two to three years of experience in academic research or pharmaceutical industry setting preferred.
• Previous experience with clinical trials required.
• Knowledge of the International Air Transport Association (IATA) regulations necessary.

Responsibilities

• Manage all aspects of study progress from start-up to close-out activities.
• Work with PIs to accomplish goals for assigned studies.
• Ensure scientific integrity of data and protect patient rights.

Skills

Experience with clinical trials

Knowledge of Good Clinical Practices

Excellent verbal and written communication skills

Attention to detail

Ability to analyze information

Education

Bachelor’s degree in a relevant field

Tools

EMR system

Job description

Clinical Research Coordinator

Westchester Medical Center Health Network

Join to apply for the Clinical Research Coordinator role at Westchester Medical Center Health Network.

Job Summary: The Research Coordinator administers and coordinates research studies and associated activities under the direction of the Director, Department of Cardiology along with the Principal Investigators (PIs) and will receive support from the centralized Office of Research and Grants Administration. The Research Coordinator will assist in managing the portfolio of Cardiology protocols and be the primary coordinator of 6‑10 sponsored clinical trials from study initiation to closure of the study.

Responsibilities

• Manage all aspects of study progress from start‑up to close‑out activities in accordance with FDA, GCP, ICH guidelines, local regulations and corporate policies.
• Work in conjunction with PIs to accomplish goals and research initiatives for assigned studies.
• Routine meetings with investigators to review study progress, protocol changes evaluation, and reporting of AEs/SAEs.
• Ensure scientific integrity of data and protect the rights, safety, and well‑being of patients enrolled in clinical trials.
• Assist PIs with planning and coordinate the review and approval processes for research study protocols in accord with established policies and procedures.
• Ensure smooth and efficient day‑to‑day operations of research and data collection activities; act as primary administrative point of contact for internal research staff and operational liaison for other research organizations, funding agencies and regulatory bodies.
• Assist in training PIs and other research staff on the use of the e‑research technology acquired by the NYRI.
• Plan and coordinate staffing of research studies including recruitment and administration of research support as appropriate to the initiative.
• Supervise and coordinate the provision of support services to investigators and researchers.
• Monitor progress of research activities; develop and maintain records of research activities and, with the PIs, prepare periodic and ad hoc reports as required by funding agencies and other regulatory bodies.
• Implement quality control processes throughout the conduct of trials.
• Ensure that all serious and non‑serious adverse events are properly documented and reported appropriately.
• Prepare for study start‑up activities and collaborate with the sponsor to coordinate on‑site qualification, study initiation, interim monitoring and close‑out monitoring site visits as necessary to ensure study requirements are being fulfilled.
• Act as liaison between the sponsor, investigator and the IRB.
• Ensure adequate protocol training is provided to the study team throughout the duration of the study so that they are knowledgeable about specific procedures of the protocol related to their delegated tasks.
• Discuss study protocols with patients and verify the informed consent documentation.
• Provide patient with written communication of their participation (e.g., 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.
• Schedule all patient research visits and procedures consistent with protocol requirements.
• Conduct the study follow‑up visits per protocol along with the investigators.
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy.
• 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.
• Responsible for preparing and submitting new research proposals, amendments, annual progress reports, DSMB reports, final study reports and other study related documents to IRB.
• Maintain and update regulatory binders on a regular basis for all the studies.
• Promptly report/submit adverse events, serious adverse events to sponsor, FDA and to the IRB per federal regulations and within defined time frame.
• Enrollment of subjects: keep track of subject screening logs, recruited subject logs, and study visit logs for accurate accountability of study drug, study materials, billing and site budget management.
• Supervise study related procedures at all levels to maintain the integrity of research studies and to avoid misconduct.
• Schedule monitor visits and set up for monitoring visits prior to monitors arrival.
• Travel to attend investigator meetings as needed.
• Other duties as assigned.

Qualifications / Requirements

• Experience: Two to three years of experience in academic research or pharmaceutical industry setting preferred; previous experience with clinical trials required.
• Bachelor’s degree in a relevant field required.
• 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.
• Experience with Investigational/Non‑Investigational drug/device studies, post‑marketing studies, investigator‑initiated studies, and health economic studies.
• 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 EMR system.
• Able to function effectively in a team setting.
• Demonstrate consistent professional conduct and meticulous attention to detail.
• Excellent verbal and written communication skills and interpersonal skills with patients, staff, and other health care professionals.
• No license or certification required.

Seniority level: Entry level

Employment type: Full‑time

Job function: Research, Analyst, and Information Technology

Industries: Hospitals and Health Care