Internal Clinical Research Associate
About the role
Internal Clinical Research Associate
Waltham, MA
Join a clinical research team that supports the execution of medical device clinical studies from study start-up through closeout. As an Internal Clinical Research Associate, you will contribute to clinical trial operations, study documentation, device accountability, data review, and regulatory compliance activities that help ensure studies are conducted according to established quality and regulatory standards.
What You Will Do
- Support site qualification, activation, monitoring, and closeout activities across multiple clinical studies.
- Manage investigational device accountability, including product serialization, inventory tracking, shipment coordination, and maintenance of device records.
- Maintain Trial Master Files and essential study documentation to support inspection readiness and regulatory compliance.
- Review, organize, and maintain informed consent forms, case report forms, and other study-related documents.
- Perform remote source data verification and study data review activities to support data quality and protocol compliance.
- Develop and maintain study metrics, reports, and dashboards that provide visibility into study progress and operational performance.
- Coordinate clinical trial registration activities and support audit and inspection preparedness efforts.
- Create study communications, newsletters, and documentation that support investigator sites and cross-functional study teams.
What You Will Need
Required Qualifications
- Bachelor's degree in Life Sciences, or a related scientific discipline.
- 0+ years of experience
Preferred Qualifications
- Experience in clinical research, clinical trial operations, or clinical study administration.
- Experience working under Good Clinical Practice (GCP) guidelines.
- Experience using electronic clinical trial databases, clinical trial management systems, or related research software.
- Experience supporting clinical trial audits, regulatory inspections, or regulatory submission activities.
- Experience with clinical trial registration platforms and study reporting processes.
US20
Not included in the source posting: about the role, benefits.
Skills
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
Read automatically from the employer's posting text. Always confirm with the employer — requirements can change after a job is published.