Clinical Research Specialist 3020005

A large pharmaceutical company is looking for a Clinical Research Specialist - II (Associate).

 Responsibilities:

§  The incumbent assists with the design and conduct of clinical studies with emphasis on the protocol/TA specific aspects of the protocol.

§  Performs medical monitoring of study data, ensuring appropriate input from clinical research physician and senior clinical research specialist staff. Responsible for the creation, review, and management of SAE case reports.

§  Supports Clinical Sciences and other functional areas in the development of clinical study deliverables.

§  The incumbent will pursue relevant training opportunities and additional project assignments with the goal of assuming increasing autonomy in the execution of responsibilities.

§  The individual will work in the CRS Safety Group processing and reviewing serious adverse experiences in a clinical study setting.

 Qualifications:

§  Must understand scientific process and have familiarity with medical and statistical concepts.

§  Must have strong analytic skills and ability to make data driven decisions.

§  Desire to work independently and ability to seek guidance as needed.

§  Must have good communication (verbal and written) and computer/database management skills.

§  Experience as a member/contributor to cross functional teams.

§  Previous Serious Adverse Experience Review and Processing in a Clinical trial setting preferred.

§  Organized and detail oriented.

§  Previous experience working with electronic data capture (EDC) systems a plus.   

§  Bachelors or higher Major relevant to Clinical Sciences i.e. Nursing, Biology.

§  Someone with a medically related background; preferably an RN.