Clinical Affairs Specialist

A Clinical Affairs Consultant job is available near Pittsburgh (Monroeville, PA). This is a 9 month contract opportunity with potential for more. This is a first shift role, but flexibility in work-hours and readiness to travel will be critical. Ability to function as a Clinical Studies Manager or Consultant will be key. The pay rate is open.


Ensure all clinical studies (multiple projects) are assigned appropriately, budgets are met, and timelines managed so that deliverables are completed per the project plan
Partner with R&D, Regulatory, Quality, Marketing, and Legal, to drive successful execution of plans/projects
Ensure (oversee/support) timely and accurate completion of trial master files, monitoring reports, regulatory binder, etc.
Act as the Clinical Trial Manager, under the guidance of your manager, for designated clinical studies


Bachelor's or Master's degree in a healthcare or science discipline
3-5 years' experience with clinical studies (CRO, medical device, pharmaceutical, healthcare, etc.)
2-3 years' experience as a (CRA) Clinical Research Associate - monitoring clinical studies
Strong knowledge of GCP, ISO standards, FDA/EU regulations, and ICH guidelines
Experience with EDC and CTMS systems is strongly preferred


Extremely good commucator: Interpersonal Relationships; Written; Spoken; Organizational
Excellent history of documenation, record-keeping, accuracy, attention-to-detail
Strong PC skills: Sharepoint and Excel are preferred

If you are interested in this role, please APPLY NOW and send a resume to
If you have questions, you can call Scott Shuman at 585.613.3028.

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Reference number US_EN_2_101083_333854