Senior Clinical Research Associate

 

Overview:

Antigenics is a biotechnology company developing technologies and first-in class products to treat cancers and infectious diseases, primarily based on harnessing the body’s immune system. Our most advanced product is Oncophage, a patient-specific cancer vaccine being evaluated in late-stage clinical trials for multiple cancer indications including kidney cancer, metastatic melanoma and brain cancer. Our portfolio also includes: (1) QS-21, the most widely studied potent adjuvant currently under investigation; (2) AG-707 in Phase 1, a therapeutic vaccine for the treatment of genital herpes which affects 21 million people worldwide each year; (3) Aroplatin, a liposomal chemotherapeutic in Phase 1 for the treatment of non-Hodgkin’s lymphoma.

 

Responsibilities:

The responsibility of the Senior Clinical Research Associate is to take a leadership role in overseeing the design, implementation and monitoring of clinical trials to insure the quality and integrity of data and safe and proper management of study parameters. In coordination with team members, exercise a leadership role for project activities related to monitoring functions by interfacing with clinical investigators and other site personnel in order to carry out this responsibility. Ability to work independently without constant monitoring and make judgments and decisions within project assignments. Performs Clinical Research Associate responsibilities relative to on-site and in-house monitoring, and study termination. 1. In conjunction with project team members from other departments, participate in the study development and startup process including: a) Reviewing protocols. b) Designing and/or reviewing CRFs. c) Developing annotated CRFs. d) Developing monitors' reference manuals and regulatory binders. e) Organizing investigator meetings. f) Identifying, qualifying and managing CROs and other vendors when necessary. g) Working with Project Manager on monitoring strategy. h) Developing project specific CRA training. i) Ensure receipt of signed investigator contract prior to shipment of study supplies, if applicable. j) Making presentations at investigator meetings. 2. Participate in protocol development, generation of standard informed consent and other related study documents and forms, as needed. 3. Site Selection: Assist with the identification of and interaction with potential investigators; assess and intervene to ensure adequacy of clinical research staff/facilities with regard to company SOPs, site SOPs (if applicable), and global and regulatory requirements; identify issues and problems for resolution and either resolve them independently or bring them to the attention of the Project Manager. 4. Study Initiation: Plan and conduct site initiation visits. Develop monitoring strategy and review for approval with immediate supervisor. Ensure correction and completion of regulatory documents; review investigator responsibilities; coordinate shipment of study-related materials. Assist in the preparation for and attend investigator meetings. Identify and follow up on outstanding issues to ensure site performance. Document visit findings. 5. Site Monitoring with aprox 30% travel required 6. In-House Monitoring and Study support including: Maintain regular telephone contact and written correspondence with site. Maintain study-specific tracking files and databases. Keep Study Team and project manager fully apprised of site and study status. Resolve DCFs via site contact. 7. Support Study Termination where applicable: 8. Serve as Project Manager or Lead CRA, as directed. Maintain contact with outside vendors and oversees study progress, timelines and deliverables. 9. Assist in CRA training programs, in conjunction with Clinical Research Training management, and serve as a mentor for CRAs and Clinical Assistants. 10. Contribute to final clinical/statistical reports, including writing clinical sections, where appropriate. Assist with preparation of INDs, investigator brochures, annual reports, integrated medical reports and other regulatory submissions 11. In lead CRA capacity, review CRA trip reports and correspondence, and is responsible for ensuring these reports are complete and accurate. 12. In lead CRA capacity may serve as CRO or vendor liaison, as directed by Project Manager. 13. Perform administrative duties including serving on clinical committees. 14. Maintain awareness of overall development in the field of clinical research, as well as knowledge of assigned therapeutic areas, by reading related literature, attending professional meetings, etc. 15. Perform other tasks as assigned by supervisor. Ability to work on complex problems requiring in depth analysis of situations and/or data. Requires excellent judgment skills in identifying, defining and implement practices and policies and critical evaluation of methods and techniques.

 

Education:

Minimum requirements include a RN, BSN, BS/MS, or BA degree or equivalent in a scientific or health care field and 3 years clinical research experience including 2 year minimum of CRA experience encompassing all the activities of a CRA, or a 2 year degree in biological sciences plus 4-5 years diverse experience in clinical monitoring. Sound knowledge of medical terminology.

 

Experience:

Sound knowledge of medical terminology. Thorough knowledge of FDA regulations, GCP/ICH guidelines, drug development process and clinical monitoring procedures. Excellent verbal and written communications skills. Excellent interpersonal and organizational skills. Ability to work independently and within a matrix team environment is required. Demonstrated ability to provide leadership to junior staff. Computer literacy preferred. Travel requirement for position incumbents up to 50%. Performance of this position requires aprox 30% travel and flexibility in actual percentage of travel and activities assigned.