Research Coordinator

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2007 sales were nearly $2.5 billion. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis.  For more information, please see www.merial.com

 

Job Description:

The incumbent is responsible for providing clinical coordination and administrative support for assigned PR&D Projects. This includes a critical quality control function. With the exception of those actions requiring clinical judgments, s/he should be capable of handling assignments independently and providing required actions to assure that the objectives of a program are met according to established timetables. The incumbent will facilitate the product development process from program inception through proof of concept and clinical trials to registration and post-market claims. The incumbent is responsible for maintaining a continuing liaison with personnel within PR&D Clinical Operations, other areas of R&D and other divisions on various aspects of the developmental clinical programs.

1. Assists Clinical Leader and/or Veterinary Scientist with administration of research, GLP and GCP studies (i.e. clinical supplies shipment, storage and disposal; data capture, data storage; study administration and status reports, draft protocols and reports, generation of quality plans, archiving, etc.). May assist the Veterinary Scientist and/or Monitor with monitoring of GCP or exploratory/research studies.
2. Maintains data verification skills and awareness of GLPs,GCPs and other requirements(including drafting and renewal of APS protocols) to the high standards expected by Merial. Participates in staff training programs to raise awareness of GLPs & GCPs.
3. Interacts with Functional Planners and other Clinical personnel to identify critical activities and ensure that target dates are met. Participates as a member of Clinical Task Forces and/or other specialized teams.
4. Assists with Quality Control and Clinical Data Management of research, GLP and GCP studies (i.e. reviews protocols, raw data, data capture forms, tabulated results, and study reports for accuracy and compliance with Merial R&D procedures, regulatory requirements, GLPs and GCPs). Assists with the resolution of Quality Assurance audits of the same. May be responsible for quality control review of clinical trial data and documents not requiring audit by Quality Assurance, or for performing basic data management tasks, as needed.
5. Works closely with the Regulatory Affairs and R&D staff from various functions in evaluating and implementing Standard Operating Procedures to assure that compliance with governmental regulations and corporate standards is maintained.
6. Assists in writing/preparing summary documents as well as compilation and QC of dossiers for regulatory submissions, as requested. Prepares and maintains study files in the Communication Center.
7. Prepares paperwork and coordinates shipment of clinical supplies/reference standards/chemical entities to trial sites. Assists Regulatory Affairs in preparing Notice of Drug Shipment forms and regulatory submissions.

 

EEO/AA/M/F/D/V

 

Qualifications:

The incumbent should possess a B.S. or M.S. degree in a biological or animal science or the equivalent. In addition, a minimum of three (M.S.) or six (B.S.) years experience in a clinical environment is required and should include an understanding of the principles of GCP, GLP and other relevant guidelines. Experience with clinical research coordination and/or clinical monitoring is highly desirable. Proficiency in word processing (Microsoft Word), spreadsheet (Excel) and other PC software is highly desirable. Good oral and written communication skills as well as good organizational skills are essential.