In-House Clinical Research Associate
- Woodcliff Lake, NJ
Global Pharmaceutical company based in Northern New Jersey
Company: Global Pharmaceutical
Title: IN-HOUSE CLINICAL RESEARCH ASSOCIATE
Location: Woodcliff Lake, NJ
W-2 Contract / Full-Time Status
12 Month Duration (w/strong possibility of renewal or convert into direct hire)
MUST have Prior In-house monitoring experience within PHARMA (Not just CRO/Med Device). Must have some Pharmaceutical employment background to apply
• Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments.
• Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.).
Participate in development of protocol, case report form, CRF guidelines and other study documents.
• Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Eisai SOPs and data issues.
• Reviews and approves monitoring reports and ensures tracking of ongoing site issues.
• Onsite Monitoring may also be required
• Minimum of college degree in a relevant discipline.
• Bachelor's degree in relevant scientific discipline preferred.
• Oncology Experience Highly Preferred
• MUST have experience with data review and patient profile review.
CANDIDATES MUST HAVE MIN 3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma. Also, want to see experience in phase 3 global study trials in multifunctional areas
* 3-5 Years In-house Clinical Monitoring Experience
* Previous Pharmaceutical employment background required
All your information will be kept confidential according to EEO guidelines.