Job Summary: The Research Coordinator for Critical Care administers and coordinates research studies and associated activities under the direction of the Director, Department of Medicine, 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 research protocols and be the primary coordinator of 6-10 sponsored clinical trials from study initiation to closure of the study.  This position will manage protocol training, data collection, data storage, and patient communications. 

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
• Assists PIs with planning and coordinates the review and approval processes for research study protocols in accord with established policies and procedures.
• Ensures the smooth and efficient day to day operations of research and data collection activities; acts 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.
• Assists in training PIs and other research staff on the use of the e-research technology acquired by the NYRI.
• Plans and coordinates staffing of research studies to include recruitment and administration of research support as appropriate to the initiative.
• Supervises and coordinates the provision of support services to investigators and researchers
• Monitors the progress of research activities; develops and maintains records of research activities and, with the PIs, prepares periodic and ad hoc reports as required by funding agencies and other regulatory bodies.
• Implements quality control process throughout the conduct of trials.
• Ensures 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.
• Acts 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 so that they are knowledgeable about specific procedures of the protocol related to their delegated tasks. Informed of/trained on pertinent changes during study.
• 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.
• 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, then file results in the patient study binder
• Submit patient reimbursement requests at the conclusion of patient’s participation in protocol
• Regulatory Affairs: 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 and within defined time frame.
• Enrollment of Subjects: 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 are credible and accurate. 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.

Qualifications/Requirements:

Experience: Two to three years of experience in academic research or pharmaceutical industry setting preferred, and previous experience with clinical trials, required.

Education:  A Bachelor’s degree in a relevant field, required.

Licenses / Certifications:  N/A

Other:  N/A

Special Requirements:

• Experienced in working on 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 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 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.