Clinical Trials Associate
at Company:
Antigenics, Inc.
in Job Category:
Clinical
posted on 10/7/08 12:00am
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Company
Antigenics, Inc.
Contact Name:
Tracy Mazza
Email:
TMazza@Antigenics.com
Website:
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Clinical Trials Associate
Responsibilities:
Under the close supervision of the Senior Project Manager, and/or Project Manager or CRA, coordinate in-house monitoring activities as related to the conduct of clinical trials. Will provide technical services for the collection, review, maintenance and tracking of regulatory documents from clinical sites. Support and assist Clinical Operations team (Project Managers, Clinical Research Associates) to ensure adherence to Good Clinical Practices internally and at investigative sites. Will develop an understanding of clinical trial research through exposure to research protocols, development process, Company Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCPs). 1. May be assigned to coordinate specific activities and assist with the following activities: In-house Monitoring a) Maintenance of Central Clinical Study Files - Track receipt; review regulatory documents; perform and document periodic file audits; follow-up with investigative sites to resolve deficiencies. b) Assist with the resolution of specific site problems as appropriate. c) Maintain telephone contact with sites and CRAs. Field phone inquiries from investigative sites and provide backup support to CRAs when they are traveling. Answer questions about patient enrollment issues, case report form completion, drug shipments, etc., keeping the CRA assigned to the site well informed of all site interactions. Document and enter into clinical administrative database relevant telephone contacts according to department procedures. d) Maintain correspondence with site and enter into clinical administrative database. e) Participate in the entry of data into clinical administrative database for clinical projects. f) Other study-related tasks, as appropriate. 2. Perform administrative and clerical duties, as directed: a) Filing, photocopying, ordering and maintaining supplies for regulatory document coordination activities and project team, as needed b) Generate and distribute agenda and minutes for protocol meetings c) Draft and prepare documents for mass mailing d) Generate special reports such as patient counts, regulatory document status, etc. e) May assist with departmental presentations (internal and external) f) Generate and/or update and help maintain project specific in-house documentation g) May assist in inter-departmental meetings 3. Maintain awareness of developments in the field of clinical research by reading relevant literature, attending clinical team meetings, etc. As appropriate, attend periodic training sessions to increase and maintain knowledge of FDA regulations, drug development process and regulatory documents requirements. Responsibilities include addressing study and site management and documentation issues of moderate complexity under direct supervision, utilizing analysis and judgment to effect solutions to meet goals and objectives.
Qualifications:
Knowledge of medical terminology preferred. Excellent verbal and written communication skills, ability to work independently, prioritize, actively seek input, problem solve and work within a matrix team environment required. Computer literacy preferred. Performance of this position requires flexibility in in-house study responsibilities that are actually assigned. Minimum requirements include a 4-year degree in a scientific or health care discipline with greater than 1 year of health care or research related experience or a 2 year degree in the scientific or health care field plus 2 years experience in clinical trials research. (Individuals with a 4-year degree in an unrelated discipline may also be considered.)
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