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ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology. ImmunoGen’s lead product candidate, mirvetuximab soravtansine, is being advanced to a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen’s ADC technology is used in Roche's marketed product, Kadcyla, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about ImmunoGen can be found at www.immunogen.com.
Reporting to the Associate Director, Clinical Operations, the Sr. CRA will be responsible for in-house support of the conduct and management of clinical studies and development program, and for ensuring global studies are conducted in accordance with SOPs and ICH-GCP guidelines. This is a blended in-house Sr. CRA role with potential to take on some activities typically handled by the Clinical Trial Manager. The Sr. CRA may be the primary contact between the Sponsor and trial sites.
Support Clinical Trial Managers in all trial-related activities from start-up through database lock and study close-out
Support and/or interface with external functions/groups including service vendors (e.g. clinical laboratories) and clinical site personnel
Provide input in the development of trial related documents including but not limited to protocols, case report forms, informed consents, monitoring plans, site reference materials, pharmacy manuals, laboratory manuals, training materials and initiation slide presentations
Assist in identifying suitably qualified trial sites
Support CRO in development and implementation of site enrollment and recruitment strategies
Make initial contacts, establish relationships with selected trial sites in order to ensure study targets for recruitment, quality and cost are implemented
Assist with procurement of clinical study supplies and supervise shipment of supplies to sites as required
Manage site regulatory authority applications and approval documentation in coordination with regulatory affairs
Review monitoring reports for trends and/or compliance issues, and manage resolution of site specific issues with CROs; proactively ensure study team is aware of all monitoring metrics and critical issues
Maintain study-specific tracking tools
Ensure proper set-up and maintenance of the Trial Master File
Conduct Sponsor Visits to study sites and co-monitoring as required
May provide study-specific direction and train/mentor CRAs
Review screening and enrollment activities for ongoing studies and provide updates in clinical study team meetings; attend project meetings and teleconferences, prepare and distribute agenda/minutes.
Assist in the preparation for site audits and inspections
Maintain good communication between study site, Sponsor and CRO.
Who You Are
Bachelor’s Degree in Life Sciences or Healthcare
5+ years of clinical research experience (CRO, Pharmaceutical, Biotechnology and/or healthcare setting)
3+ years of site management and field monitoring experience
Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
Experience as a Lead CRA preferred
Proficient in Microsoft Word, Excel, PowerPoint; e-CRF and IVRS, project management tools
Travel required approximately 25% for co-monitoring and training as needed
Experience in Phase I - III in various therapeutic areas (Oncology preferred)
Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
Excellent written, verbal, and presentation skills
Thorough knowledge of ICH-GCP, applicable regulations and monitoring practices
Flexible, highly motivated and proactive, able to work independently; organized; team player
ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche'...s Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.