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.

RESPONSIBILITIES:

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

REQUIRED/PREFERRED:

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

OTHER/SOFT SKILLS:

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 scott.shuman@adeccona.com.
If you have questions, you can call Scott Shuman at 585.613.3028.

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Reference number US_EN_2_101083_333854