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University of Southern California Clinical Research Associate - Medical Monitor in San Diego, California

Clinical Research Associate - Medical MonitorApplyUSC Alzheimer's Therapeutic Research InstituteSan Diego, California

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.

Incumbent will provideoversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operation Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements(s). Duties will include but are not limited to:

  • Supports study design, generation of study protocol, CRF, informed consent, and other study material.

  • Supportsmedical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluatesand assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events duringcourseof study.

  • Pefroms MedDRA coding

  • Attends and/or presents at investigator, internal and external project team meetings.

  • Assesses and evaluates protocol deviations and recommends on actions to be taken.

  • Contributes to discussions with investigators, opinion leaders, internal and external clients.

  • Interacts with site clinical monitors to provide medical support

  • Provides benefit/risk evaluations and drug safety expertise for drugs

  • Contributes to and reviews Safety Management Plans,Medical Monitoring Plans, Pharmacovigilance Plans, Risk Management Plans including design and conduct of safety studies.

  • Evaluates spontaneous reports and literature cases.

  • Communicates with reportingsite investigatorsand site staff regarding medical and safety issues.

Location: San Diego, CA

Salary is dependent on education and experience.

COMPLETED POSITION QUESTIONNAIRE REQUIRED FOR POSTING.

Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education

Minimum Experience: 3 years

Minimum Field of Expertise: Directly related professional experience in area of program specialization.

REQ20072274 Posted Date: 03/15/2019 - Thru date - 2019-07-31

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