Medical Trial Specialist - Biotech

Job Description:
Medical Trial Specialist
Basic Qualification:

BA/BS in Biological Sciences, RN, ( or Pharm D with limited industry experience).

5 years experience in life science or medically related field including 2 to 3 years Clinical Development/Industry experience (eg CRA, CTS equivalent).

Sr. Medical Trial Specialist
BA/BS in Biological Sciences, RN, ( or Pharm D with some clinical research experience).

6 years experience in life science or medically related field including 3 to 5 years Clinical Development/Industry experience (eg CRA, CTS equivalent).

Basic Business Skills:
-Good organizational and planning skills
-Strong interpersonal skills and communication skills (both written and oral).
-Ability to work effectively in a team/matrix environment
-Demonstrated ability to write and present clearly using scientific and clinical issues terminology.
-Ability to understand technical, scientific and medical information
-Ability to problem-solve
-Ability to deal with time demands, incomplete information or unexpected events
-Advanced computer skills

Clinical Research Skills
-Robust skills in business reasoning as applied to the support of late phase or marketed products through medical studies
-Familiarity with appropriate Good Clinical Practices (GCP) and FDA regulations and guidelines
-Familiar with advanced concepts of clinical research including late phase studies Experience with development of prospective site-selection criteria.
-Familiar with budgeting & contracting processes
-Experience with administration of site budgets and grants with supervision
-Experience in interactions with outside vendors, e.g., CROs and contract labs
-Experience with reviewing adequacy of site-proposed informed consents (ICs) for compliance with relevant regulations
-Experience in independent preparation of clinical sections of IND, BLA, or NDA.
Job Summary:
Under minimal supervision of the Senior Manager or Manager, Medical Research Management, the Medical Trial Specialist II will coordinate the activities associated with the evaluation, initiation and management of Medical Research clinical trials.

Specific job duties
Protocol Documents
1. Contribute to the preparation of protocols and amendments
2. Assist in and co-ordinate the design, format and content of CRFs, study guides and subject instructions
3. Draft and assist in the preparation the sample informed consent
4. Track and confirm that essential documents are received and maintained
5. Support the preparation of clinical reports & manuscripts when needed

Study Conduct
1. Support the feasibility assessment of new clinical protocols
2. Coordinate and assist in the activities associated with site start-up and management
3. Coordinate and assist in the arrangements for investigational product
4. Assist in the identification and recruitment of investigators
5. Manage the overall Investigational product accountability and reconciliation process
6. On the study level, coordinate and manage the Investigational product accountability and reconciliation
7. Ensure that that CRF data queries are resolved
8. Track study-related trend.Please e-mail your resume for immediate consideration to phoward at our office onsite at Amgen: or phoward

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Job Experience:
call for details, Clinical Research,Good Clinical Practices (GCP),

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