Clinical Research Coordinator II -… at Dana-Farber… · Boston…

Summary: Dana-Farber Cancer Institute is a leader in groundbreaking cancer research and patient care. The Clinical Research Coordinator II will support the research team in the conduct of clinical trials, ensuring compliance with regulatory requirements and managing patient clinical information. Responsibilities: - Oversight of the clinical trials regulatory process at the DFCI Satellite(s) and site activation activities - Communication and coordination with the lead study team at the Longwood campus for study start-up, ongoing study team meetings, and project management of all site study activities - Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s) - Prepare and/or complete regulatory related reports and IRB submissions as it pertains to the satellite’s studies. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis - Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion - Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations - Responsible for organizing and preparing for both internal and external auditing and study monitoring visits - Coordination and management of all clinical trials at the Satellite site(s), including communication with Sponsors and regulatory authorities - Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved - Interact with study participants as directed/required by the protocol and/or study team - May be responsible for tissue sample work - Travel between DFCI satellite locations to support all above research activities when cross coverage is needed - Maintain working knowledge of current regulations, regulatory guidance and or local policies - May be responsible for preparing and presenting study status regulatory status for satellite site clinical team members at monthly research meetings Required Qualifications: - Bachelor's degree - 1 to 3 years of related experience - Excellent organization and communications skills - Strong interpersonal skills with the ability to effectively interact with all levels of staff and external contacts - Detail oriented with the ability to follow-through - Ability to effectively manage time and prioritize workload - Practice discretion and adhere to hospital confidentiality guidelines at all times - Computer skills including the use of Microsoft Office Preferred Qualifications: - Experience working in a medical or scientific research setting or comparable technology oriented business environment Required Skills: Clinical Practice (GCP), Clinical Research Coordination, Clinical Trials Regulatory Process, Data Management, Case Report Forms (CRF) Completion, Adverse Event Reporting, IRB Submissions, Regulatory Compliance, IATA/DOT Shipping Regulations, Microsoft Office