Clinical Trail Specialist- Bio Tech

Job Description:
Clinical Trial Specialist
Typically 4 years experience in life sciences or medically related field, including at least 2 years experience in Clinical Development (e.g., CRA, CTS equivalent).

BA/BS in biological sciences or related field, or RN (or Pharm D with some industry experience)
Sr CTS
Typically 6 years experience in life sciences or medically related field, including at least 3 years experience in Clinical Development (e.g., CRA, CTS equivalent). Therapeutic experience in nephrology, endocrinology, or cardiology is preferred. Strong interpersonal skills and communication skills (both oral and written) along with good organizational and planning skills. Ability to deal with time demands, incomplete information or unexpected events and work effectively in a team/matrix environment. Experience in interactions with outside vendors e.g., CROs and contract labs. Other skills include advanced computer skills, experience with administration of site budgets and grants with supervision and experience with reviewing adequacy of site-proposed informed consents for compliance with relevant regulations.
Job Summary:
Under direct supervision of Senior Clinical Research Manager or Clinical Research Manager, coordinate the activities associated with the evaluation, initiation and management of Clinical Development clinical trials.

Assist in the design, format and content of CRFs. study guides and subject instructions. Coordinate the preparation of Monitor Workshops and Investigator Meetings. Track CRO and third party vendor activities. Contribute to the preparation of clinical protocols and amendments. Assist in the identification of investigators. Coordinate the activities associated with site start-up and management including the preparation of and support for administration of study budgets. Monitor progress of studies identifying delays and initiate corrective actions when necessary. Track study-related trends. Support the preparation of Clinical Study Reports, annual IND Safety Reports, and clinical sections of BLA/NDA. Please e-mail your resume for immediate consideration to phoward at our office onsite at Amgen: or phoward@

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call for details, MS Word, MS Excel

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