Exp. with data review, AE,or writing patient narratives? Clinical Research Sci in Collegeville, PA!

Experience with data review, adverse events or writing patient narratives? Kelly Scientific Resources has a great opportunity for a short term contract at a major pharmaceutical company in Collegeville, PA.


DESCRIPTION:
'Participate in preparation of routine clinical documents, i.e., protocols, ICFs, CSRs, CRFs, etc.

'Prepares complex documents with moderate supervision and routine documents independently as directed by supervisor i.e., CPAR, CDP, IND documents, etc.

'Evaluates and selects potential investigative sites with minimal to moderate supervision.

'Organizes and presents complex aspects of protocol design at investigator and internal meetings.

'Coordinates and monitors activities at clinical investigational sites with minimal supervision by medical monitors and/or project monitors.

'May participate in training/mentoring new hires.

'Monitors safety with minimal to moderate supervision via any of the following: telephone contacts, adverse event reports, case report form/safety report reviews, contacts with CRAs, CRA monitoring trip reports, or direct site visits.

'Participates in data review and discrepancy resolution, may coordinate activities of junior staff.

'Participates in team meetings/presentations with increasing levels of independence.

'Serves as protocol lead as well as a member of a broad range of CR&D related and ad-hoc committees, as needed.

'May represent organizational unit at research-wide meetings and on committees, including Global Clinical Project Teams and Interdepartmental Project Teams.

'Serves as a clinical science resource for the team(s), and for peers and/or subordinates.

Required/Desired Skills:
*Must have a BS or equivalent plus 5 years related clinical experience or a MS degree or equivalent in Life Science plus 4 years related clinical experience.

*Must have experience with the following: clinical data review/analysis/interpretation (not data management), AE/SAE reconciliation, writing patient narratives. MS Office ' including Excel ' experience is required.


Kelly Scientific Resources is one of the many divisions under Kelly Services. Kelly Scientific Resources (KSR) provides staffing services on temporary and full time project based positions. KSR works on positions in industries such as Biomedical, Clinical Research and Pharmaceutical. Kelly Services is a fortune 500 company and an equal opportunity employer.


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