Clinical Project Scientist - San Diego, CA
Kelly Services - San Diego, CA

This job posting is no longer available on Kelly Services. Find similar jobs: Clinical Project Scientist jobs - Kelly Services jobs

Job Description:
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.

Summary:
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.

Requirements:
  • 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.
Job Code : BHJOB3479_593184

Kelly Services - 19 months ago - save job - - block
Recommended Jobs
Clinical Laboratory Information Management Sy...
Sequenom - San Diego, CA
Sequenom - 22 days ago

Associate Scientist, Biotherapeutics Job
Jserver - San Diego, CA
Go Job Search - 2 days ago

SCIENTIFIC DIR, BIOMARKER SIGNATURES Job
Janssen Research & Development, LLC. (60 - San Diego, CA
HireDiversity.com - 22 days ago
About this company
2,470 reviews
Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...