In House CRA Role

Midwest City  ‐ Onsite
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Keywords

Description

Clinical Research Associate (SR CRA and CRA 11)

12 month contract with possibility of extension

Location: Remote-Midwest/Northeast (Traveling 3 days a week)

Rate: $60- $70 an hour (W2 or C2C)

My Client, is looking for a Senior CRA or Senior Remote Monitoring Manager to join them ASAP on an initial 12 Month Contract.
The Senior CRA will work with the Clinical Research Specialist to satisfy applicable regulatory standards and company requirements for worldwide Clinical Studies.
This position bridges the responsibilities of the Clinical Research Coordinator and the Clinical Research Specialist, and focuses on study management activities, oversight of CRO's, etc.

Description of Duties:
- Assists with successful conduct of assigned studies consistent with R&D and Marketing plans.
- Includes interfacing with representatives from key functional groups including Field Clinical Operations, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups.
- Assists in preparation of study materials and training of investigators, center staff and field staff.
- Writes the monitoring plan. Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
- Reviews clinical data/information and oversees data correction.

- Assists clinical research specialists in providing interim and final reports and presentations.
- Provides input to study budgets and project plans.
- Assists clinical research specialists by providing sections of Investigational Plan or protocol as needed.

Key skills:
- Associates Degree minimum, with 4-6 years clinical research experience as a CRA or
- Bachelors (Four year) degree with 3-5 years clinical research experience as a CRA

- Medical Device Experience

- Cardiovascular Experience

- Experience managing multiple sites and intra-project initiatives
- Study start up experience
- IDE study experience
- Ability to travel 60%
- CRO/vendor management a plus
- Expertise with GCPs and regulatory compliance guidelines for clinical trials.

Please send me your most up to date Resume if you would like to be considered for the role.
Start date
06/2014
From
Real Staffing
Published at
04.06.2014
Project ID:
720467
Contract type
Freelance
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