Clinical Research Coordinator

Westchester Medical Center • Valhalla, NY

300d

About The Position

The Research Coordinator administers and coordinates research studies and associated activities under the direction of the Office of Research and Grants Administration. The Research Coordinator will assist in managing a portfolio of General Surgery and Neurosurgery protocols and be the primary coordinator of 6-10 sponsored clinical trials from study initiation to closure of the study. This position will manage regulatory, protocol training, data collection, data storage, and patient communications.

Requirements

• A minimum of two to three years of experience in academic research or pharmaceutical industry setting preferred.
• Previous experience with clinical trials required.
• A 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.
• Knowledge of EMR system.
• 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.
• 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.

Nice To Haves

• Previous experience with clinical trials preferred.
• Experienced in working on Investigational/Non-Investigational drug/device studies, Post marketing studies, Investigator Initiated studies and Health Economic studies.

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 PI's 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 coordinates the review and approval processes for research study protocols in accord with established policies and procedures.
• Ensure the smooth and efficient day to day operations of research and data collection activities.
• Act as primary administrative point of contact for internal research staff (nurses, data manager, and pharmacist) and as the 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 to include recruitment and administration of research support as appropriate to the initiative.
• Supervise and coordinate the provision of support services to investigators and researchers.
• Monitor the 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 process 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.
• Act as a liaison between the sponsor, investigator and the IRB.
• Ensure adequate protocol training is provided to the study team throughout the duration of the study.
• Discuss study protocols with patients and verify the informed consent documentation.
• Provide patient with written communication of their participation.
• 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.
• Ensure that non-serious and serious adverse events are properly documented and reported.
• 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.
• 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.
• Responsible for promptly reporting/submitting Adverse Events, Serious Adverse Events to the sponsor, FDA and to the IRB per federal regulations.
• Must keep track of subject screening logs, recruited subject's logs, and study visit logs for accurate accountability of study drug, study materials, billing and site budget management.
• Maintain appropriate and accurate source documents to track the reported data/results.
• 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 monitor's arrival.
• Travel to attend investigators meetings as needed.
• Other duties as assigned.

Benefits

• Health Insurance
• Dental
• Vision
• Retirement Savings Plan
• Flexible Savings Account
• Paid Time Off
• Holidays
• Tuition Reimbursement

What This Job Offers

• Career Level: Entry Level
• Industry: Hospitals
• Education Level: Bachelor's degree