Job Title: Clinical Research Specialist

Job Location: Upper Gwynned, PA

Job Description:
The Clinical Research Specialist’s will support the MRL clinical monitors who oversee the conduct of Phase II/III clinical trials. Responsibilities include, but are not limited to: assist in medical data review, order study related supplies, screen and tabulate clinical data (excel spreadsheets), and write clinical study documents / reports. As needed, the incumbent may be required to create and maintain computer databases and spreadsheets, process adverse experience and site monitoring reports, reconciliation or to assist with any other aspect of the management and conduct of the assigned clinical trials.
With the exception of actions requiring medical judgment, the incumbents provide support to assure that program objectives are achieved.

* Must have authored a Clinical Study Report (CSR).
* Must have authored a clinical protocol.
* Must have some medical writing of clinical research documents (not pre-clinical i.e. laboratory documents). For example Safety update reports to the FDA (SUIR or PSUR); Annual IND reports.
* Knowledgeable of multiple Clinical and Regulatory databases, guidance, SOPs, CBER/CDER, GCP’s, GMPs, ICH guidelines, and policies in addition to clinical practices such as Phase I Phase II, Phase III, and Phase IV clinical trials, study protocols, on-site monitoring practices, study initiation and close-out practices, and audit trails.
* Track patient enrollment, monitor visit reports, and monitoring visits.
* Update, review, and track study and regulatory databases for trials.
* Submit, process, and track BLA PLAs, NUNs, INU’s, and other regulatory and clinical documentation.
* Prepare and review monthly biologic reports for the US Regulatory Affairs, Vaccines Department.
* Study report writing.
* Site (liaison) monitoring experience.
* Study Start start-up experience.

Person of Contact:
Jennifer Samara
Phone: 1-800-844-2276
Email: jsamara@acrocorp.com