Clinical Research Associate I
The Clinical Research Associate I supports clinical trial operations by assisting senior CRAs with site monitoring activities, data verification, regulatory document management, and participant safety checks under close supervision. This entry-level role ensures protocol adherence and data integrity through detailed review and coordination, contributing to the successful conduct of clinical studies at Confidential Client.
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.
Role overview
Confidential Client is seeking an entry-level Clinical Research Associate I (CRA I) to support clinical trial monitoring activities with close supervision. This role supports remote and occasional on-site monitoring performed by senior CRAs and project leadership. Location: Austin, TX (telecommute/remote-eligible). This is an opportunity to gain hands-on monitoring experience, exposure to EDC/CTMS tools, and career development in clinical operations.
Key responsibilities
- Support site monitoring activities: assist senior CRAs with qualification, initiation, monitoring, and close‑out visits; participate in remote or in‑person visits in a shadow/support capacity.
- Perform supervised source data review (SDR) and basic source data verification (SDV).
- Draft and update visit documentation (for senior review) and prepare materials for monitoring visits.
- Assist with data quality and query support: conduct chart reviews, track queries, and escalate discrepancies.
- Support essential document management (TMF/ISF): collect, upload, organize, and verify regulatory documents under supervision.
- Help verify participant safety and compliance: preliminary consent checks, AE/SAE documentation review, and eligibility confirmation.
- Contribute to study start‑up and training: prepare feasibility/site assessment documentation, training materials, and maintain training logs.
- Maintain trackers and systems: update CTMS, EDC task lists, issue logs, and monitoring calendars.
- Support investigational product documentation and basic audit/inspection readiness activities.
- Perform other related duties as assigned to support study teams and site relationships.
What we’re looking for
- Bachelor’s degree in life sciences, nursing, public health, or a related field (required).
- Basic understanding of GCP and human subjects protection.
- Strong attention to detail and ability to follow SOPs precisely.
- Learning agility — receptive to feedback, quick to apply new processes.
- Good written and verbal communication; professional interaction with site staff.
- Planning and organizational skills to prepare visit files and trackers.
- Ability to work collaboratively with CRAs, CRCs, data management, regulatory, and pharmacy teams.
Preferred
- At least 1 year of clinical research support experience (e.g., CTA, CRC assistant, research intern).
- Familiarity with EDC and CTMS systems.
- Knowledge of risk‑based monitoring concepts.
- GCP (ICH E6) training, institutional human subjects training, or relevant certifications (ACRP/SOCRA) are a plus.
Licenses / Certifications
- None required at hire.
- Preferred: ICH E6 GCP training; IATA certification (if handling specimens); ACRP or SOCRA certifications (not required at hire).
Salary & compensation
- Posted salary: $40,623+ depending on qualifications. (This reflects the posted minimum; total compensation may vary by experience and internal equity.)
- Telecommute/remote-eligible position — see jobLocationType TELECOMMUTE in structured data.
Working environment & equipment
- Standard office equipment; frequent computer/keyboard use.
- Remote work tools and occasional travel to site locations may be required.
Required application materials
- Resume/CV
- Letter of interest
- Three work references with contact information (at least one from a supervisor)
Application notes
- Applicants who are not current employees of Confidential Client must upload all required materials when applying.
- If you are a current employee of Confidential Client, follow internal application procedures as directed by your HR or People team.
- Note (Texas compliance): per Executive Order No. GA‑48 of the State of Texas, positions that research, work on, or have access to critical infrastructure require the ability to maintain the security or integrity of that infrastructure.
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.
If you have questions about how your data is used, please contact us directly.
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