|
|
 |
|
|
|
Clinical Research Associate
Closing Date: August 31, 2010
| Company: | Ferring Pharmaceuticals, Inc.
Parsippany, NJ |
| Job Location: |
Parsippany - Morris County
|
| Employment Type: | Full Time |
| Department: | FIPCUS (Clinical R&D) |
| Benefits: | Medical Coverage, Dental Coverage, Prescription Drug Coverage, Fertility Drug Benefit, Life Insurance, Accidental Death & Dismemberment, Insurance, Short Term Disability Insurance, Long-term Disability Insurance, Health Care Flexible Spending, Account, Dependent Care Flexible Spending Account, Employee Assistance Program, 401(K) Program, Vacation Program, Personal Days, and Holidays |
Description: | SUMMARY:
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 sites 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.
QUALIFICATION REQUIREMENTS:
Education
Requires a Bachelor's degree or equivalent preferably in a science related field.
Experience
Prior work experience in the health care system preferred. Minimum of 2 -3 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.
Supervision Necessary
Requires occasional supervision while working toward specific goals within predetermined deadlines. Meets regularly with supervisor to communicate study progress and to schedule study sites visits. Refers critical questions to supervisor.
Effect of Errors
Errors in communicating protocol information to study sites, or incomplete critical documents are detected in the normal quality assurance process, but errors may result in significant loss of time, additional travel expense, general loss of efficiency and impair data quality.
Contact With Others
Spends over half of time in direct contact with investigators, study site personnel and department personnel providing and seeking information. Must be able to plan and make presentations, clearly articulate protocol information verbally and in writing and conduct himself/herself in a professional manner so as to present a professional image of FPI.
Mental/Visual/Physical Demand
Requires normal ability to concentrate on relatively heavy flow of paper and information. May travels up to 10% of the time on occasions.
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.
|
|
|
|
|
