Spec, Clinical Development-S&I - San Juan Capistrano, CA
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POST DATE 8/25/2016
END DATE 10/10/2016
San Juan Capistrano, CA
JOB DESCRIPTIONThe Journey Begins with you.
There's quite a distance between wondering and knowing. And for patients waiting for answers to important health questions, it's a road they want to travel as quickly as possible.
At Quest Diagnostics Incorporated, we understand urgency. But more than speed, we focus our energies on accuracy. Currently, we seek a Spec, Clinical Development-S&I - San Juan Capistrano, CA.
Schedule: Monday Friday, 8am 5pm, Day shift, Quest Temporary
*Salary dependent upon experience*
REQ # 3763801
A Clinical Development Coordinator will work with Quest Medical and Laboratory Directors and their staff, Clinical Development management and staff, external scientific and clinical administrative staff and external vendors to support S & I clinical development research efforts. The Clinical Development Coordinator is responsible for oversight of all operational aspects of clinical studies including; clinical study initiation activities, site selection and training efforts, study documentation, study site monitoring, query resolution, data monitoring and data flow, study site payment activities, study close down. This person will report to Clinical Development Management.
1. Develop study initiation and management plans with Clinical Development Management.
2. Assist with assessing site/investigator interest and feasibility, site selection, initiation/training, provisioning of study materials to study sites, site monitoring and resolution of study-related problems.
3. Track study progress, adherence to protocol, data submission, deviations and discrepancies.
4. Communicate with sites on a regular basis, send updates on current status of study enrollment and follow study-related queries until resolved.
5. Work with Biorepository staff to ensure efficient and accurate study sample management and relay information on sample transfer to/from analysis lab personnel.
6. Provide sample handling expertise and guidance during project design and operation.
7. Build, populate and maintain study document folders.
8. Proactively look for and communicate potential program risks to Clinical Development Management and provide possible mitigation strategies.
9. Work with data management to design CRFs and resolve data discrepancies.
10. Work as a research services manager for select sites and external vendors. Monitors routing and status of contracts and agreements.
11. Collaborate and coordinate activities with other Coordinators to ensure continuity of study management.
12. Collaborate effectively with all internal and external Clinical Development partners and customers.
13. Coordinate payments to study sites and vendors and subject reimbursements.
14. Perform remote or on-site monitoring visits.
15. Assist with and oversee efforts provided by third party vendors such as CROs.
16. Co-manage a study status database with other Coordinators.
17. Assess resource demands and report needs to Clinical Development Management to assure timely achievement of program deliverables.
18. Perform other duties as assigned.
Clinical Development Coordinator S&I
Job Code: XXXXXX
April 11, 2014
1. Demonstrate effective written and verbal communication skills.
2. Ability to set priorities and address high priority tasks as appropriate.
3. Demonstrate strong problem solving skills, adapt current job skills and learn novel approaches to solve problems
4. Able to drive innovation by embracing diversity and change.
5. Possess outstanding organizational skills and the ability to work on multiple projects at one time.
6. Proficient in the use of Microsoft Office.
7. Possess a fundamental knowledge of clinical and scientific research.
Bachelor s Degree preferably in health, life sciences with three or more years experience working in the capacity of a clinical research study coordinator or a minimum of five years of clinical research experience or five years experience in a similar capacity.
Working knowledge of Good Clinical Practices (GCP s) and International Conference on Harmonization (ICH) guidelines and/or Clinical Laboratory Improvement Amendments (CLIA).
How To Apply
Please Log In or Register to Upload a Resume and complete the online Application. Because of the large number of applicants to job openings, Quest Diagnostics will only contact candidates to be interviewed
Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patient comes first and that values do matter. We work to earn our customers trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. Our workforce is diverse and talented and believes in our vision: "Empowering Better Health with Diagnostic Insights."
[All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.]
Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity.