p>Initiates and continues regular contact with patients; encourages visit reminders and compliance to research; ensuring contact with patients and their families is courteous, effective, professional and cooperative, Maintains accurate, timely, and audit-ready source documentation in accordance with GCP and ALCOA principles,
Documents and reports informed consent, adverse events, serious adverse events, protocol deviations, and safety concerns in accordance with Sponsor, IRB, FDA, and institutional requirements,
Supports sponsor monitoring visits, internal audits, and regulatory inspections,
Collaborates with the Principal Investigators to oversee the conduct of assigned studies and participates in research program development and planning,
Prepares, submits, and archives IRB applications, amendments, continuing reviews, deviations, study closure documentations, and other regulatory and essential documents,
Utilizes electronic data capture systems, clinical trial management systems, and electronic medical records to maintain accurate study documentation and data integrity,
Assists investigators with data compilation, abstracts, manuscripts, presentations, and publication- related activities,
Processes, tracks, stores, and ships biological specimens per protocol and institutional requirements,
Develops and maintains budgets, financial tracking logs, invoices, patient stipends, and other finance related documents,
Attends and maintains appropriate trainings including but not limited to, Good Clinical Practice and Ethics/IRB,
Collaborates with various personnel and staff to execute research activities and provides general or protocol specific in-service/trainings, as applicable,
Acts as a liaison for the Clinical Research Office to all assigned service lines/ therapeutic areas,
Collaborates with the Clinical Research Office to support, coordinate, and advance departmental initiatives,
Conducts all other duties and responsibilities as assigned,
At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees physical, emotional, social, and financial health.
Functions as a Study Coordinator on Investigator-Initiated projects, registries, and clinical trials,
Maintains thorough knowledge of research studies including, but not limited to, study rationale & objectives, study subjects, and schedule of events,
Supports participant recruitment, screening, enrollment, and retention efforts to meet study accrual goals,
Facilitates end-to-end clinical trial operations across all study visits, pre-activation setups, participant follow-ups, and study close-out procedures.