Clinical Studies Specialist

Description

Location/Site: Hybrid - Irvine, CA (on-site at least 3 days/week)

Clinical Studies Specialist I - Skincare (Contingent)

• In House CRA, Clinical research coordinator will also work for this role
• Excellent communication skills
• Day to day work will include corresponding with external HCP, study forms, TMF, shipments, create CRF, supporting IRB submission, data review, completion of CRF, some statistical analysis, data entry,
• Excel savvy, PowerPoint
• Help with study documents, data entry
• Understanding documents, study start up, close out
• Supporting external sites: HCP
• This is a team of clinical study specialists
• Supporting studies from contracts start up from start to finish
• Knowledge of GCP
• This will be lot less rigorous compared to drugs
• Entering data from CRF in to excel
• Work on result presentation, study design
• Background in clinical research
• Exp with GCP and clinical studies needed
• Bachelors degree needed

Purpose:

• The Clinical Studies Specialist I (contingent) - Skincare (contingent role) will assist the Skincare Clinical Studies Specialist I and the Director II, Clinical Development and Global Scientific Affairs- Skincare with the operational execution and management of Skincare clinical research studies conducted with CROs and HCP research sites.
• The Clinical Studies Specialist I (contingent) will assist the Clinical Studies Specialist I with all clinical research activities from start-up to close out, data management and results presentations.
• The role is responsible for drafting study documents, organizing eTMF, CRF review, data entry, study photo transfer and presentation creation, and managing and summarizing data/results.

Responsibilities:

• Assists in the development and preparation of study protocols, informed consent documents, CRFs, subject instructions and all related study materials. Helps create and maintain the trial master file for each clinical study.
• Supports clinical study supply ordering and shipment as needed.
• Assists in performance tracking metrics for all activities needed for the execution of each assigned clinical study. Provides updates to the team as needed.
• Tracks receipt of completed study data, performs data entry and conducts statistical analysis, or assists in the management of a CRO to conduct the statistical analysis.
• Assists in the review of study data and supports generation of photo presentations, clinical study results presentations and summaries.

Qualifications - External

• Bachelor’s Degree in a scientific field and two or more years of experience in a clinical research position.
• Strong knowledge of Good Clinical Practices and application to the conduct of clinical trials in the United States highly desirable.
• Highly attentive to detail and experienced in working in Excel, Powerpoint and Word.
• Strong communication skills, both verbal and written.
• Skilled at managing data and knowledge in statistics
• Function in a controlled/regulated environment and handle restricted, confidential, private and personal information.