Senior Clinical Research Associate
About The Position
The Senior Clinical Research Associate (Sr. CRA) supports Study Leads in clinical study planning, execution, and management. The role primarily supports the COM/Study Lead with study set-up, execution, oversight, and closeout, ensuring compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines, and governing policies and procedures. The Sr. CRA supports study teams with essential document and Trial Master File (TMF) activities, investigational product and ancillary supply management, site feasibility and activation, monitoring report review, study document quality control and development, data reviews, and study status updates. The role also works with CROs and central or referral laboratories to support study start-up and execution, provides guidance to junior team members as assigned, and contributes to process improvements and procedural compliance.
Requirements
- Five years of experience in clinical research and development.
- Three years of onsite monitoring or site management experience.
- Experience managing or supervising vendors.
- Highly proficient knowledge and understanding of ICH-GCP.
Nice To Haves
- Four-year college degree.
- CRA certification.
Responsibilities
- Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents.
- Routinely monitor TMF inspection readiness for assigned studies.
- Assist the Study Lead with investigational product and ancillary supplies management, accountability, and reconciliation activities.
- Collect and/or review Essential Documents from investigational sites.
- Review informed consent documents for accuracy and completeness.
- Support investigator identification, feasibility, and activation activities.
- Review monitoring visit reports for accuracy and completeness.
- Support the Study Lead in preparing materials for study-wide meetings, including investigator, interim update, and data safety committee meetings.
- Perform quality control of study-level documents, including master informed consent forms, study plans, manuals, CRFs, and CRF completion instructions, for formatting, spelling, grammar, accuracy, and consistency with study protocols.
- Contribute to the development of study-level documents, including templates, manuals, guides, and newsletters.
- Provide study and site status updates as needed to ensure timely study entry and updates on ClinicalTrials.gov or an equivalent platform.
- Perform periodic data reviews as requested by the Study Lead.
- Prepare and present updates at team meetings as assigned by the Study Lead.
- Support central or referral laboratory set-up and timely activation, including specifications and user manuals, as delegated by the Study Lead.
- Work closely with the CRO to plan study start-up and ongoing study execution activities as assigned by the Study Lead.
- Provide guidance and training to junior-level team members as assigned by management.
- Recommend modifications to SOPs and work instructions when necessary to improve compliance or efficiency.
- Participate in process improvement projects, including SOP and work instruction development.
- Maintain compliance with assigned procedures, guidelines, study plans, and applicable regulatory requirements.
Benefits
- Competitive salaries.
- Excellent benefit package.
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
Senior
Education Level
No Education Listed
