Medical Device Clinical Research Project Manager Jobs

St. Francis Hospital, The Heart Center is New York State's only specialty designated cardiac center. A member of Catholic Health, St. Francis is consistently recognized by U.S. News & World Report as a national leader for Cardiology & Heart Surgery, as well as for Gastroenterology & GI Surgery. Additionally, U.S. News rates St. Francis as high performing in Geriatrics, Neurology & Neurosurgery, Orthopedics, and Pulmonology. Nursing care at St. Francis is also nationally recognized, with multiple Magnet designations, as well as the AMSN PRISM Awards and Beacon Awards. St. Francis has regularly out-scored other hospitals on Long Island.

The Research Coordinator is responsible for coordinating and managing clinical research studies involving pharmaceuticals, medical devices, registries, and observational trials. Working collaboratively with investigators, research nurses, physicians, sponsors, and hospital departments, this role supports all phases of clinical research, including study start-up, subject screening and enrollment, data collection, regulatory compliance, study monitoring, and project coordination. The Research Coordinator ensures accurate and timely collection of research data while maintaining the highest standards of patient confidentiality, data integrity, and regulatory compliance.

• Read, interpret, and analyze clinical trial protocols to understand study rationale, design, objectives, eligibility criteria, and study requirements.
• Collect, review, and abstract pertinent clinical information from medical records while maintaining strict patient confidentiality and compliance with HIPAA and institutional policies.
• Review and analyze source documentation for accuracy and completeness and enter study data into case report forms (CRFs) and electronic data capture (EDC) systems as directed by the Research RN or department leadership.
• Retrieve and organize research-related documentation, including medical records, angiographic films, CDs, radiology images, echocardiograms, electrocardiograms (EKGs), and procedural reports for study files and submission to sponsors or core laboratories.
• Assist with the initiation and activation of new pharmaceutical and medical device clinical trials by attending study start-up meetings, summarizing protocols, and preparing documentation for sponsors and institutional review committees.
• Screen internal databases and medical records to identify potential research participants through review of diagnostic testing, imaging studies, invasive and non-invasive procedures, and clinical reports.
• Collaborate with Research RNs, investigators, and physicians to coordinate patient selection and facilitate subject enrollment.
• Develop protocol-specific source documents, data collection tools, workflow processes, and subject enrollment procedures to support study implementation and data quality.
• Coordinate sponsor monitoring visits, audits, and regulatory inspections by preparing requested documentation and working with research staff to ensure timely completion.
• Maintain study tracking systems using Microsoft Word, Excel, Outlook, and research databases to monitor subject enrollment, follow-up visits, protocol deadlines, study milestones, and financial information.
• Coordinate retrospective and prospective observational studies and research registries by collecting data from medical records and entering information into electronic databases or sponsor-specific case report forms.
• Provide cross-departmental coordination to ensure protocol requirements are met, including collaboration with laboratory, imaging, pharmacy, and clinical departments for specimen processing, testing, and shipment.
• Coordinate and manage clinical research studies within the hospital, serving as lead coordinator or project manager as assigned.
• Assist with education and training of physicians and hospital staff on research protocols and study-specific procedures.
• Serve as a resource and mentor to junior research staff by providing guidance on clinical trial processes, protocol implementation, and research documentation.
• Complete all required institutional, regulatory, and sponsor training.
• Perform additional duties and special projects as assigned by department management.

• Bachelor's degree in Science or a related field required.
• Master's degree in Science or a related field preferred.
• Medical degree (MD) may be considered in lieu of the above education requirements.

• Knowledge of clinical research methodology, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Ability to interpret and implement complex clinical trial protocols.
• Strong analytical, organizational, and project management skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple studies and competing priorities while meeting deadlines.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook) and electronic research databases.
• Strong attention to detail with demonstrated accuracy in data collection and documentation.
• Ability to work collaboratively with physicians, research staff, sponsors, and multidisciplinary hospital departments.
• Ability to maintain confidentiality and exercise sound professional judgment.

This range serves as a good faith estimate and actual pay will encompass a number of factors, including a candidate's qualifications, skills, competencies, and experience and position location. The salary range or rate listed does not include any bonuses/incentive, differential pay or other forms of compensation that may be applicable to this job and it does not include the value of benefits.

At Catholic Health, we believe in a people-first approach. In addition to the estimated base pay provided, Catholic Health offers generous benefits packages, generous tuition assistance, a defined benefit pension plan, and a culture that supports professional and educational growth.