Clinical Research Coordinator, HSS Center for Regenerative Medicine

About the role

Integrated in the Center for Regenerative Medicine (CRM), the Clinical Research Coordinator will work closely with Sports Medicine physicians (Principal Investigators) and will directly report to the AVP, Clinical Operations Officer and Chief Pharmacy Officer.

Responsibilities

• Screening and enrolling patients following inclusion/exclusion criteria
• Collecting biospecimens both in the office setting and the OR
• Data management activities while assuring compliance with protocols and ICH GCPs
• Assisting with protocol development
• Submitting new and continuing review to the IRB
• Coordinating clinical and lab activities to integrate all protocol activities
• Maintaining regulatory binders, liaising with communications and preparation of documents for the FDA
• Participating in all aspects of research management and quality assurance of data for the Principal Investigator
• Overseeing and conducting the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training)
• Managing data collection specific to research studies including performance of measurements for applicable studies, collection of clinical data from patients directly, and managing performance of all other duties as put forth in the protocol
• Collaborating with multidisciplinary teams involved in the successful initiation and conduct of clinical research studies and clinical trials (clinical research administration, legal, finance, compliance, etc.)
• Spearheading efforts to meet patient enrollment targets related to independent research studies
• Developing and implementing various recruitment strategies and providing regular enrollment updates to the Principal Investigator
• Ensuring subject research visits and follow-ups are scheduled within the protocol specified time frame and that all required assessments and procedures are performed per the protocol
• Coordinating with both the research subject (by phone, email, or mail per compliance) and with physician office staff and ancillary departments
• Managing and executing IRB submissions for initial approvals, re-approvals, amendments, etc.
• Ensuring timeliness and accuracy of submissions and no lapses in approvals for the study
• Coordinating with Principal Investigator, ancillary department, central research administration, and compliance office to ensure that clinical research and related activities are performed in accordance with federal and HSS regulations and sponsoring agency policies and procedures
• Performing advanced data queries when needed
• Providing timely reports to the Institutional Review Board, Principal Investigator, Research Director, National Institutes of Health and/or sponsor for each research project
• Participating in the development of new protocols, prospective databases and new initiatives (may include independent design of databases and tools to facilitate data collection as required for specific projects, e.g. calendars, schedules, tracking logs)
• Collaborating with the research team and research administration to ensure that research subjects are treated in accordance with all mandated requirements
• Ensuring that standards regarding subject registration, protocol specific tests, and required documentation are adhered to
• Reporting deviations as appropriate and resolving issues when possible; escalating issues to supervisor as needed
• Assisting in collecting, transporting, processing, and storing biospecimens obtained from research patients to the lab
• Maintaining and enhancing professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of clinical research and regenerative medicine

Qualifications

• Bachelor's degree required; Master's preferred
• ACRP, SOCRA, or similar certification preferred
• 3-5 years' experience in clinical research
• Deep knowledge of FDA regulations for clinical trials
• Strong organizational and problem-solving skills
• Attention to detail
• Excellent written and communication skills
• Proficient use of computers and software
• Familiar with electronic data capture platforms such as RedCap and EMRs platforms (Epic)

Skills

• Proficiency in Microsoft Excel, Outlook, PowerPoint, and Word
• Excellent verbal and written communication skills
• Excellent organizational, problem-solving, customer service, and interpersonal skills
• Ability to multitask
• Knowledge of Good Clinical Practice for the handling of specimens and blood
• Knowledge of Human Subjects research regulations and HIPAA compliance
• Knowledge of FDA regulations for clinical trials
• Knowledge of Orthopedic and/or Rheumatologic terminology is preferred