Clinical Trials Specialist
7 days ago
We are seeking a skilled Clinical Trials Specialist to join our team at Planet Technology. In this role, you will be responsible for coordinating study designs in support of internal and external activities within the organization.
You will work closely with various teams, including Watson Designers, Study Director/BPI, Sample Manager Teams, and Clinical/Pre-Clinical Sites. Your primary responsibilities will include:
- Performing sample reconciliation as needed.
- Providing colleague training on study designs cross-departmentally.
- Supporting study design creation and employee training for other sites.
Responsibilities
As a Clinical Trials Specialist, you will be primarily responsible for the coordination of study designs. This will involve creating and verifying Watson LIMS study designs based upon study protocols, while coordinating design requests and assigning these to appropriate members.
You will also investigate and resolve issues related to study designs, perform sample associations based upon sponsor manifests, and facilitate study designs for data reporting.
In addition, you will contribute to study design assessment meetings to determine the best approach in the creation of study protocols, manage discrepancies related to sample reception, and author file memos to ensure proper execution.
Requirements
To be successful in this role, you will need to have:
- A BSc. Or higher degree in Life Sciences or a related area.
- Experience working for a CRO and within regulated environments to include FDA, GLP, GCP, and TPD.
- 2+ years in Clinical Research with 1+ years exposure to LIMS.
- A history of working within Clinical studies coordination to include dealing with Study Protocols and Plans from various clinical trials (phases I-IV), and Safety Assessments (Pre-Clinical Toxicology Studies).
- Experience with SampleManagement, Ligand Binding Assays, and/or Mass Spectrometry.
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