About this role
About the Role The Zakim Center for Integrative Therapies and Healthy Living is recruiting a Clinical Research Coordinator II (CRC II). The CRC II is a critical member of the research team who will support oncology exercise and nutrition interventions for patients and survivors, manage data, and assist with regulatory and trial start-up activities under the PI and Associate Director of Research Operations.
What You'll Do
- Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities
- Data reporting and management, collection of source documents, development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries
- Prepare or complete regulatory reports and IRB submissions as needed
- Maintain and organize study participant/subject trial binders and regulatory binders, enter study data on an ongoing basis
- Ensure all study-related samples are collected, properly prepared, and shipped according to protocol requirements and IATA/DOT regulations
- Collaborate with Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments as required
- Organize and prepare for internal and external auditing and study monitoring visits
- Coordinate and manage clinical trials throughout the life cycle, including communication with sponsors and regulatory authorities
- Close-out of clinical trials, contribute to research articles, audit preparation, and communication with regulatory agencies
- Interact with study participants as directed by protocol and/or study team
- May be responsible for tissue sample collection per trial requirements
What We're Looking For
- Excellent organization and communications skills
- Strong interpersonal skills with ability to interact with all levels of staff and external contacts
- Detail oriented
- Effective time management and ability to prioritize workload
- Discretion and adherence to hospital confidentiality guidelines
- Computer skills including Microsoft Office
Compensation & Benefits
- Salary: $56,000.00 - $63,700.00 per year USD