Clinical Project Scientist
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Clinical Project Scientist working with our client based in San Diego, CA.
The Clinical Program Scientist CPS brings scientific, operational, and project management expertise to protocol development, study planning / execution, and data evaluation.
Job Responsibilities (other duties may be assigned):
Develop/Write Phase I/II Clinical Trial Protocols with team. Manage/coordinate all aspects of clinical trial, including operations and contracting.
Lead and/or manage protocol development, including coordination of protocol-related reviews and writing of protocol.
Coordinate writing of IB, CSR and other clinical documents.
Support scientific discussions with consultants.
Serve as the primary contact person for study management.
Lead phase I/II working group meetings and clinical team meetings as needed, including preparation of agenda, minutes, and action items.
Support regulatory and EC/IRB submissions and work with regulatory team to consolidate clinical response to regulatory or EC/IRB questions.
Coordinate data visualization/DMC activities.
Provide study updates to team members and management.
Be point person for vendor contract negotiation, execution.
Work with team to: Manage study timelines, oversee study budgets and review recruitment plan. Track study progress, coordinate trouble shooting and issue resolution. Develop ICF and CRFs, select vendors, review vendor budgets, scope of work and training manuals.
Provide input and feedback for:
Country do-ability/site feasibility evaluation and country/site selection.
Mitigation and contingency plans.
Trial plans, monitoring guidelines, data management plan, and other clinical trial documents.
Work with clinical leader/medical monitor to:
Develop content and plan for investigator meetings, including protocol/compound training.
Review incoming study data for trends and issues, review protocol deviations, provide retraining to sites and monitors, work with data managers and vendors to reconcile data discrepancies.
Review statistical analysis plan, review data listings and tables, contribute to data mining strategy, interpret study results, and review clinical study report.
Candidate must have a track record of Clinical Studies experience (very important).
At least MS or equivalent in a Biomedical Science required.
Excellent technical writing and communication skills are critically important.
Strong organizational skills, thoroughness, and attention to detail.
Strong team orientation, strong people skills.
For immediate consideration, click the Apply Now button, or refer a friend by clicking the E-mail this job link provided.
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com .
Kelly Services is an Equal Opportunity Employer.
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class
staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.
Revenue in 2012 was $5.5 billion.
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