Contract In-House Clinical Trial Manager / Monitor

We have 5 new positions for contract in house Clinical Research Associates (Clinical Scientists) located in Blue Bell or Upper Gwynned campus in Pennsylvania needed for immediate start with a large, well-respected pharmaceutical company!

These are full time contract opportunities with at least 6 months with opportunity for extension beyond.

-Candidates MUST have authored a Clinical Study Report (CSR).
-Candidates Must have authored a clinical protocol or have experience reviewing the following types of medical writing clinical research documents (not pre-clinical):
-Safety update reports to the FDA (SUR or PSUR)

-Annual IND reports

-Knowledge of multiple Clinical and Regulatory databases, guidance, SOP's, CBER/CDER, GCP's, GMP's, ICH guidelines, and policies

-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 trials.


Education requirements:

-Minimum Nursing degree or Bachelor's degree in the health or sciences (with 1 year related experience in a clinical related field).

Key Words: Clin*, Pennsylvania, Philadelphia, monitor, clinical research, clinical trial, protocol, Medfocus, pharma*
REQUIREMENTS
Please see above.