Dana-Farber Cancer Institute
Boston
Located in Boston, Dana Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, 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.
GENERAL SUMMARY:
This position will work within the clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program’s physicians and research nursing staff, are responsible for the design, implementation and evaluation of their program’s clinical research activities, related regulatory oversight, and direct supervision of their program’s clinical research staff.
PRIMARY DUTIES AND RESPONSIBILITIES:
Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Oversees processing of protocols through DFCI Institutional Review Board (and other institutions’ IRBs) when appropriate. Oversees regulatory process for related studies. Collaborates with the Office for Human Research Studies (OHRS)l, the Quality Assurance for Clinical Trials (QACT), and the Clinical Trials Office (CTO) to fulfill federal requirements governing human clinical trials. Completes all annual review requirements.
Collaborates with the DFCI QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control.
Oversees study enrollments and appropriate protocol treatment and follow-up care for patients in clinical trials.
Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff has completed mandatory training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff.
Assists the principal investigator in preparing manuscripts for publication.
Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs.
Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol.
Assumes responsibilities for data management. Maintains schedules and procedures necessary for timely and complete data collection.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Bachelors Degree preferred. Minimum of 3-5 years of related experience preferred. Must have the ability to function independently, with little supervision.
full time
Monday - Friday
8:30 - 5:00
Full-Time
