Clinical Data Associate
MSC is currently searching for a Clinical Data Associate to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on-site in Bethesda, MD.
The Clinical Data Associate provides subject matter expertise for clinical data management on NIH clinical trials. The Clinical Data Associate oversees data management of multiple complex studies, completes data entry and abstraction, conducts data quality control, and serves as an internal data management expert.
Duties & Responsibilities
- Adhere to NIH Clinical Data Management project timelines on multiple complex protocols.
- Support data abstraction from patient records and data entry of assigned studies, gather and enter data in accordance with SOPs and protocol specific processes.
- Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study.
- Work in a team environment to support eCRF design and end user testing.
- Develop protocol specific data management plans ensuring alignment with protocol and data quality standards.
- Conduct data quality checks and data reviews.
- Provide data management support in preparation for and response to continuing reviews, monitoring visits, data safety monitoring board (DSMB) meetings, and audits.
- Participate in cross-functional process initiatives and clinical research team meetings.
- Abstract and grade adverse events based on the protocol specifications and SOPs.
- Other duties as assigned.
- Bachelor’s degree in Life Science or related field.
- One to two years’ experience in data management.
- Knowledge of Federal information technology, the Biotech or Pharmaceutical Industry, or equivalent comparable background.
- Experience with clinical trial databases and electronic data capture (EDC).
- Experience with GCP and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and compliance with safety, ethical, legal, and regulatory standards.
- Experience with Microsoft Excel for data reporting.
- Skills in prioritization, organization, and time management.
- Experience with clinical/medical terminology and abstracting data from patient records.
- Good communication skills.
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