Job Title : Clinical Data Specialist
Location : Remote
Duration : 6 months
 
Job Description:
 
The Clinical Data Specialist requires in depth knowledge and experience in clinical data management with demonstrated capabilities in coordinating data management activities across multiple studies. The Clinical Data Specialist contributes to data management process improvements and initiatives within the department and all aspects of the clinical data management lifecycle.
 
Responsibilities:

• Assist with the creation and/or review study-specific Case Report Forms (CRFs) using device study knowledge and protocol specific information in collaboration with clinical team.
• As applicable, contribute to the development of Case Report Form Library of common forms that can be used consistently across studies.
• Support EDC database development(s).
• Participate in the validation and User Acceptance Testing (UAT) of EDC databases.
• Develop and/or review study-specific data management and database documentation, which may include Data Management Plan (DMP), CRF Completion Guidelines (CCGs), Annotated CRFs, Edit/Logic Check Specifications, and UAT Plans.
• Collaborate with clinical team members to generate data review guidelines and perform data review and query generation/closure.
• Prepare data for scheduled snapshots/database locks and perform archival activities upon study completion.
• Attend study-specific team meetings and produce requested metrics, which may include query information or data trends.
• Train Investigators and Coordinators on the EDC system, and CRF completion guidelines as needed.
• Manage EDC user access for sponsor and site personnel.

 
Education and Experience

• Bachelor’s degree is strongly preferred
• Requires 2+ years of clinical data and EDC experience
• Strong computer skills with a proficiency with MS Windows based applications
• Working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials including applicable ISO regulations for any trials conducted globally

 
Preferred Skills and Competencies:

• Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule
• Excellent written and oral communications skills required
• Comfortable with multiple Electronic Data Capture (EDC) Systems
• Strong organizational skills and attention to detail.
• Ability to work independently and manage multiple tasks in a fast-paced, changing environment.

 
Travel Requirements:

• This position requires some travel up to 5% of the time.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 57.00/hr.