Clinical Data Coordinator

Employer: PRA Health Sciences

Responsibilities

Supports activities related to development of the clinical data management systems (CDMS).
Processes and reviews the CRF, third party data, and local laboratory data, if applicable.
Supports and leads the clinical data review activities associated with a clinical trial.
Prepares and completes quality control reviews and delivers the end product of clinical data that meets agreed upon data integrity standards
Serves as lead clinical data coordinator for one or more projects.
Reviews clinical and external data for subjects enrolled in clinical research protocols based on edit specifications / data validation programs to facilitate data review.
Maintains Data Management Plan (including CRF related components) as appropriate.
May be responsible for data entry activities, quality control reviews, identification and documentation of data problems during CRF tracking, Casebook
Manager set-up and maintenance and serve as primary contact for data entry activities for functional management and internal study team members.
Performs proficient reviews of study datasets prior to client transfer.
Manages the data review and external data reconciliation process.
Mentors and trains other team members in data management skills and processes for individual studies.
Utilizes internal systems to optimize and communicate resourcing issues and needs.
Ensures study and task metrics are tracked and communicated to the project team and functional management.
May participate in sponsor and/or thirdparty audits

Qualifications