Clinical Research Associate
Artech Information System LLC
Apply to this jobArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Medical Affairs - Global Oncology
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, Client SOPs and data issues. Reviews and approves monitoring reports and ensures tracking of ongoing site issues.
Minimum of college degree in a relevant discipline.
Bachelor's degree in relevant scientific discipline preferred.
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. MUST HAVE experience in reviewing patient data and patient profiles.
**Oncology Experience Highly Preferred
BS
Best Regards,
Akriti Gupta
(973) 967-3409
Morristown, NJ 07960
Summary
Manage clinical trial operations, oversee site activities, review patient data, ensure regulatory compliance.
Job title
Clinical Research Associate
Experience level
3-5 years
Industry
healthcare
Location requirements
Woodcliff Lake, NJ, US; on-site preferred
Salary
Not specified
Visa sponsorship
H-1B sponsor history
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Woodcliff Lake, NJ, USA