Located in Boston, Dana Farber Cancer Institute brings together world-renowned clinicians, innovative researchers, and dedicated professionals as allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
This position will work within the Center for Neuro-Oncology clinical research program and supports the Neuro-Oncology research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT).
PRIMARY DUTIES AND RESPONSIBILITIES:
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.
Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
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 clinical trials, 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.
Performs basic technical procedures as directed. Collects medical data from paper and electronic sources, both internal and external. Maintains timely follow-up of protocol patients. Maintains on-going communications with DFCI staff for data collection needs. Accesses demographic and clinical information from the clinical systems. Prepares and submits protocol application packets, amendments to protocols, continuing review forms and adverse event reports to IRB and Sponsor. Prepares summary data reports for manuscripts and presentations. Understands basic principles of human research subject protection. Works independently under general supervision.May handle specimens, including collection, appropriate packing and shipping of specimens in accordance with all safety regulations. May administer Quality of Life surveys and interviews. Participates in Quality Control and Quality Improvement initiatives.
PATIENT CONTACT: Will have contact with Adult patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients.
WORKING CONDITIONS: External and internal applicants, as well as position incumbents who become disabled as defined under the Americans With Disabilities Act, must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case-by-case basis.
CRC’s must be able to lift and carry boxes, otherwise normal office environment.
DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
Bachelor’s Degree preferred.
0-2 years of related experience preferred.
Requires close to moderate supervision. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
Excellent organization and communications skills required.
Strong interpersonal skills – ability to effectively interact with all levels of staff and externals contacts.
Must be detail oriented and have the ability to follow-through.
Ability to effectively manage time and prioritize workload.
Must practice discretion and adhere to hospital confidentiality guidelines at all times.
Must have computer skills including the use of Microsoft Office.
This position is full-time, Monday through Friday, 40 hours per week.
Dana-Farber Cancer Institute is an Affirmation Action/Equal Opportunity Employer, committed to diversity and inclusion in our workforce.
Dana-Farber Cancer Institute - 10 months ago