Job Overview:
The Senior Clinical Research Associate III monitors investigational sites to ensure subject safety and provide high quality data review and reporting in compliance with the Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. Builds, manages and supports strong site relationships while serving as liaison between the Sponsor and assigned sites.
Job Duties and Responsibilities:
1. Act as the primary liaison between Sponsor and investigational sites.
2. Conduct all types of site visits (pre-study, initiation, interim, and close-out) per monitoring plans.
3. Ensure compliance with protocols, GCP/ICH guidelines, SOPs, and applicable regulations.
4. Verify subject eligibility, informed consent, safety, and accurate data collection.
5. Perform source data verification and ensure timely resolution of queries.
6. Manage investigational product accountability and trial supplies.
7. Support site start-up, regulatory document collection, and IRB/IEC submissions.
8. Identify, escalate, and resolve site issues proactively.
9. Participate in audit preparation, training, feasibility assessments, and team meetings.
10. Provide mentorship to CRAs and contribute to project training and documentation.
11. Assist with sponsor communication, protocol clarifications, and budget coordination.
12. May support bid defense presentations and co-monitoring activities.
Supervisory Responsibilities:
No supervisory responsibilities.
Job Requirements:
13. Education4-year college graduate, preferably with a healthcare or life science degree.In lieu of a degree, candidates with 5 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
14. ExperienceSignificant experience in on-site monitoring of clinical studies.Monitoring experience in multiple, complex indications and study types including inpatient, FIH, Phase I, critical care.Experience in all areas of monitoring (on-site, remote, etc.)
15. CapabilitiesAbility to negotiate effectively, resolve conflicts and build consensus.Ability to drive an automobile and have a valid driver’s license, if applicable.Valid passport required in the case of international business travel.Ability to travel up to 80%.
If you're a motivated CRA ready to make a difference in a company that values your voice — we want to hear from you.
Apply now and help shape the future of clinical trials at Caidya.
#LI-remote
#LI-MY1 V1
The company will not accept unsolicited resumes from third party vendors.