Clinical Data Monitor I - Hybrid
About The Position
The Clinical Data Monitor is responsible for clinical data management activities for the Caris sponsored and collaborating protocols and projects. This role ensures the highest standards of data integrity and quality in support of critical research efforts to improve treatment, health, and medical outcomes for oncology patients. The Clinical Data Monitor I provides support to both external and internal research coordinators in patient enrollment, data collection, and data query resolution. Responsibilities include oversight and management of clinical investigative sites in accordance with Federal Code of Regulations, Good Clinical Practices (GCP), Good Registry Practices (GRP), ICH Guidelines, local regulations, and applicable Compliance and Sponsor SOPs.
Requirements
- 3-5 years of experience in data collection activities within a GCP regulated clinical research environment.
- Proficient in Microsoft Office Suite
- Experience working with Electronic Data Capture (EDC) systems.
- Clinical study experience in oncology.
- Strong understanding of medical terminology.
- Ability to work independently and make sound decisions.
- Strong organizational skills with the ability to prioritize, meet deadlines, and manage multiple projects simultaneously.
- Demonstrated ability to build trust with site personnel and communicate effectively with diverse stakeholders.
- High attention to detail with a passion for contributing to meaningful research outcomes for patients.
- Strong problem solving skills and the ability to deliver practical solutions.
- Excellent written and verbal communication skills in English.
- Professional demeanor with positive, collaborative interactions with internal and external partners.
- Ability to propose, implement, and evaluate appropriate resolutions to issues.
Nice To Haves
- Bachelor’s degree preferred
- Research Coordinator certification (SoCRA, ACRP)
- Working knowledge of human anatomy.
Responsibilities
- Maintains proficient knowledge of Electronic Data Capture (EDC) systems to support training, change proposals, and user acceptance testing.
- Establish and maintain strong working relationships with site data and regulatory coordinators.
- Perform quality control review of submitted Case Report Forms (CRFs), including source document verification and issuance of data queries.
- Serve as an evaluator for internal Clinical Research Coordinators in training and provide detailed, constructive feedback.
- Maintain regulatory documentation for all assigned sites and study staff.
- Create and manage site records within the EDC for newly onboarded sites.
- Conduct quality control audits of the clinical database.
- Ensure compliance with GCP guidelines, FDA, Institutional Review Board (IRB), HIPAA regulations, site operating procedures, and ethical standards for the conduct of clinical research.
- Collaborate closely with onsite teams to confirm appropriate consenting is completed and documented prior to data abstraction.
- Communicate effectively with research teams, investigators, study sponsors, and ancillary staff.
Benefits
- All job specific, safety, and compliance training will be assigned based on the responsibilities associated with this position, including but not limited to: Good Clinical Practices (GCP), Human Subject Protection (HSP) Training, SEER Primary Site Training, Multiple Primary and Histology Rules, AJCC Staging
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
