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
Job Responsibilities (other duties may be assigned):
with team. Manage/coordinate all aspects of clinical
- Develop/Write Phase I/II Clinical Trial Protocols
trial, including operations and contracting.
coordination of protocol-related reviews and writing
- Lead and/or manage protocol development, including
- Coordinate writing of IB, CSR and other clinical
- Support scientific discussions with consultants.
- Serve as the primary contact person for study
team meetings as needed, including preparation of
- Lead phase I/II working group meetings and clinical
agenda, minutes, and action items.
with regulatory team to consolidate clinical
- Support regulatory and EC/IRB submissions and work
response to regulatory or EC/IRB questions.
- Coordinate data visualization/DMC activities.
- Provide study updates to team members and
- Be point person for vendor contract negotiation,
Work with team to:
review recruitment plan.
- Manage study timelines, oversee study budgets and
and issue resolution.
- Track study progress, coordinate trouble shooting
vendor budgets, scope of work and training
- Develop ICF and CRFs, select vendors, review
Provide input and feedback for:
- Country do-ability/site feasibility evaluation and
management plan, and other clinical trial
- Mitigation and contingency plans.
- Trial plans, monitoring guidelines, data
Work with clinical leader/medical monitor to:
meetings, including protocol/compound training.
- Develop content and plan for investigator
review protocol deviations, provide retraining to
- Review incoming study data for trends and issues,
sites and monitors, work with data managers and
vendors to reconcile data discrepancies.
listings and tables, contribute to data mining
- Review statistical analysis plan, review data
strategy, interpret study results, and review
clinical study report.
Studies experience (very important).
- Candidate must have a track record of Clinical
- At least MS or equivalent in a Biomedical Science
are critically important.
- Excellent technical writing and communication skills
attention to detail.
- Strong organizational skills, thoroughness, and
For immediate consideration, click the Apply Now button,
- Strong team orientation, strong people skills.
or refer a friend by clicking the E-mail this job link
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:
Kelly Services is an Equal Opportunity Employer.
Job Code : BHJOB3479_593184
Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable...