CLINICAL TRIAL ASSOCIATE
The successful candidate will assist with daily clinical trial execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
- Responsible for study laboratory sample management, including tracking and vendor management support
- Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
- Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
- Responsible for quality control of the eTMF including maintenance and oversight
- Coordinate and manage version control of clinical documents.
- Prepare distribution of copies of finalized protocol and study documents. Assemble investigator and pharmacy manuals
- Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
- Assist in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
- Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
- Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
- BS/BA degree or equivalent and at least year experience in clinical operations in Sponsor company with 1+ years strongly preferred
- Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required
- Experience with eTMF; ability to directly apply essential document knowledge to file documents
- Strong communication, organizational and interpersonal/team skills
- Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
- Participate in inter-departmental workgroups to create or enhance processes
- Strong customer service orientation
- Strong attention to quality/detail
- This position is based on-site at the Company’s headquarters located in Cambridge, MA
Jounce Therapeutics is an immuno-oncology company dedicated to transforming the treatment of cancer. The company is discovering and developing novel cancer immunotherapies designed to harness the immune system to attack tumors and provide long-lasting benefits to patients. Jounce integrates translational science insights including identification of related biomarkers designed to match the right immunotherapy to the right patients. The company is advancing programs that leverage contributions from its world-class founders as well as knowledge acquired from Jounce’s Translational Science Platform to create a sustainable “discovery to human proof-of-concept” product engine with the potential to drive significantly more durable responses to treatment. Founded by world leaders in tumor immunology, cancer biology and clinical and translational medicine, Jounce Therapeutics was launched in 2013 with funding from leading life sciences investor, Third Rock Ventures. In July, 2013 Jounce entered into a strategic partnership with Celgene Corporation to Develop Next-generation Immuno-oncology Therapies for patients with cancer.