Clinical Research Associate I
The Clinical Research Associate I at Confidential Client supports clinical trial operations by assisting senior CRAs with site monitoring activities, data verification, regulatory document management, and participant safety checks. This entry-level role ensures protocol adherence and data integrity through detailed review and coordination under close supervision, contributing to the successful conduct of clinical research studies.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Position overview
Confidential Client is seeking an entry-level Clinical Research Associate I to support clinical trial site monitoring and documentation. This role is based in Bee Cave, TX (Bee Cave, Texas) and may include remote monitoring activities. The CRA I provides operational support under close supervision to help ensure protocol adherence, participant safety, and data quality.
What You’ll Do
- Assist senior CRAs and project leadership with site qualification, initiation, monitoring, and close‑out visit preparation and follow-up.
- Participate in remote and on-site monitoring visits in a shadowing or support capacity.
- Perform supervised source data review (SDR) and basic source data verification (SDV) to confirm data accuracy and completeness.
- Draft and update visit documentation (e.g., visit notes, follow-up lists) for senior review.
- Conduct chart reviews and basic checks for completeness, accuracy, and consistency under supervision.
- Track and help resolve data queries with site staff following guidance from senior CRAs or data management.
- Collect, upload, organize, and track essential regulatory documents (TMF/ISF) and perform version checks.
- Prepare document packets, trackers, and materials for monitoring visits and audits.
- Perform preliminary checks of consent documentation and review AE/SAE listings, flagging issues to senior staff.
- Support study start-up tasks including feasibility documentation, training preparation, and scheduling.
- Update CTMS, EDC task lists, issue logs, and monitoring calendars; prepare routine status updates.
- Assist with IP accountability documentation and review of pharmacy logs as directed.
- Support audit/inspection readiness by assisting with document retrieval and CAPA tracking.
- Perform related duties as required.
Who You Are / Qualifications
Minimum qualifications:
- Bachelor’s degree in life sciences, nursing, public health, or related field (or equivalent education/experience).
- Basic understanding of GCP and human subjects protection.
- Strong attention to detail and ability to follow SOPs strictly.
- Comfortable learning monitoring tools (EDC, CTMS) and applying feedback quickly.
- Good written and verbal communication skills; able to draft clear visit notes and queries.
- Able to prioritize tasks and escalate uncertainties appropriately.
Preferred qualifications:
- At least 1 year of clinical research support experience (e.g., CTA, CRC assistant, research intern).
- Experience with EDC/CTMS systems and familiarity with risk‑based monitoring concepts.
- GCP (ICH E6) training and institutional human subjects training upon hire.
- Certifications such as ACRP or SOCRA (preferred, not required).
Employment details & salary
- Employment type: Full-time (may include contractor engagements as noted by project).
- Weekly scheduled hours: 40 hours.
- FLSA status: Exempt.
- Position duration: Expected to continue through Aug 31, 2027; renewal based on funding/performance.
- Earliest start date: Oct 05, 2026.
- Salary: $40,623+ depending on qualifications.
Working environment & requirements
- Standard office equipment; frequent computer/keyboard use.
- May involve travel to clinical sites for on-site monitoring visits.
- This role requires strict adherence to internal controls, SOPs, and reporting structure.
- Background check required for finalists.
- E-Verify and I-9 employment verification apply where required.
Application materials
Please be prepared to provide:
- Resume/CV.
- Letter of interest.
- Three work references with contact information (at least one supervisor).
Additional notes
Careertakes has presented this opportunity for Confidential Client in the Scientific & QA industry. This posting is non-discriminatory and compliant with applicable US employment laws. Reasonable accommodations are available for applicants with disabilities; contact the recruiter via the Careertakes platform if you need assistance.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
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