Clinical Research Associate
Location: Parsippany New Jersey
Description: Ferring Pharmaceuticals, Inc. is at the momment seeking for Clinical Research Associate right now, this job will be placed in New Jersey. For complete informations about this job opportunity kindly see the descriptions. Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets innovative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years Ferring has expanded beyond its traditional European base, with over 3,700 employees worldwide, it operates subsidiaries in over 45 countries and makes its products available in more than 70 countries.
Ferring US development organization of Ferring Pharmaceuticals, Ferring International Pharmascience Center U.S. Inc (FIPCUS), develops new groundbreaking medicine that can enhance the quality of life for people. To sustain this effort, we reward talent with influence. In return, we expect our employees to be people of ambition.
The CRA participates in the conduct of single and multi-center clinical research studies by contributing to investigator meetings, recruiting investigators, monitoring study sites, maintaining critical documentation, participation in report preparation including protocols final integrated reports and providing general oversight for one or more studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Participates in planning of study implementation with department managers. Participate in protocol development and case-report form design as assigned.
- If a remote data capture application is utilized during the study, become fully familiar with the application, so that data is efficiently and in compliance with SOPs captured at the Investigator sites.
- Reviews protocols to become familiar with details of single and multi-center research studies. Communicates with study personnel to confirm and clarify protocol guidelines.
- Uses internal investigator lists and externally published sources to contact potential investigators and key opinion leaders. Reviews basic protocol information with investigators and solicits information necessary to perform initial evaluation of site’s eligibility for study.
- Assist in vendor identification, assessment and management
- Prepares and presents protocol and general study related presentations at investigator meetings to ensure that investigators are adequately informed of protocol requirements, standard operating procedures and monitoring procedures.
- Travels to study sites to monitor and co-monitor progress of studies. Collects, reviews and corrects case report forms in accordance with study specific timelines. Travel is about 10%.
- Monitors progress of patient enrollments and other benchmarks to assess ongoing progress and adherence to study protocol by the investigator sites.
- Prepares program and study status reports for CRM and therapeutic team.
- Maintains study files by reviewing and archiving critical documents such as IRB approvals, FDA 1572 and adverse experience forms as well as all study related correspondence.
- Monitors study master file at clinical research organization
- Performs other technical and administrative duties as reasonably assigned by the CRM.
Education
Requires a Bachelor's degree required, preferably in a science related field.
Experience
Prior work experience in the health care system preferred. Minimum of 2 years experience. Must have experience with site initiation, regular monitoring and site close-out visits.
Initiative, Judgment, and Complexity
Works within departmental standard operating procedures, Good Clinical Practices and FDA guidelines to ensure proper implementation of research studies. Works under direction of CRM to plan workload and schedule site visits, but exercises some judgment in scheduling and planning workload involving multiple projects to meet required deadlines. Generally works on several tasks concurrently. Exercises some general procedural precedents. Refers unusual and critical decisions to supervisor. Must have good written and verbal skills to effectively communicate with investigators, sponsors and other departmental personnel about protocol related topics. Must be able to effectively plan and make presentations to investigators and study site personnel.
Mental/Visual/Physical Demand
Requires normal ability to concentrate on relatively heavy flow of paper and information. May travel up to 10% of the time on occasion.
The above is intended to describe the essential job functions and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Ferring Pharmaceuticals, Inc..
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This job starts available on: Tue, 21 Aug 2012 21:51:58 GMT
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