Senior Clinical Research Associate - EAST COAST

Crinetics Pharmaceuticals, Inc.; Headquarters (ID); Hybrid; USD 119,000 - 149,000; Full time

Benefits offered by this job

Discretionary annual target bonus

Stock options

401(k) match

20 days of paid time off

10 paid holidays

Job summary

Crinetics Pharmaceuticals, Inc. is seeking a Senior Clinical Research Associate to oversee Phase 1-3 clinical trials, ensuring compliance with Good Clinical Practices. The Sr. CRA will work closely with the Clinical Trial Manager, performing site visits, managing site activation tasks, and ensuring data integrity.

Qualified candidates will have a BS in biological sciences and at least 5 years of experience. The position offers a salary range of $119,000–$149,000 and comprehensive benefits including health insurance and paid time off.

Qualifications

• At least 5 years of experience as a Clinical Research Associate.
• In-depth understanding of study protocols.
• Demonstrated application of Good Clinical Practices.

Responsibilities

• Develop and maintain relationships with investigational sites.
• Conduct site monitoring visits in compliance with GCP/ICH.
• Generate comprehensive visit reports.

Skills

Critical thinking

Root-cause analysis

Problem-solving

Strong negotiation skills

Excellent written and oral communication

Education

BS in biological sciences or related discipline

Job description

Position Summary: The Senior Clinical Research Associate (Sr. CRA) will participate in the preparation and execution of Phase 1-3 clinical trials. The Sr. CRA oversees the progress of clinical investigations by conducting site qualification, initiation, interim, and close‑out visits. The Sr. CRA monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Crinetics Pharmaceuticals and partner CRO(s). The Sr. CRA works closely with the Clinical Trial Manager (CTM) and Clinical Monitoring management to ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also participate in monitoring oversight activities such as CRO oversight visits, internal CRA training and evaluation visits, and CRO monitoring visit report review.

Responsibilities

• Develop and maintain strong, collaborative relationships with investigational sites throughout the trial lifecycle.
• Perform site qualification, initiation, interim, and close‑out visits in compliance with GCP/ICH requirements, SOPs, and protocol.
• Coordinate and manage site activation tasks in collaboration with the study team.
• Conduct remote and on‑site monitoring, ensuring subject rights, safety, and data integrity.
• Generate comprehensive visit reports and letters in a timely manner.
• Review and verify study records, source documents, case report forms, consent forms, and other materials to ensure data completeness and accuracy.
• Resolve data queries and entry errors, and investigate serious adverse events.
• Assess and monitor investigational product receipt, storage, administration, and accountability processes.
• Monitor and review essential regulatory documentation and ensure submission to the TMF.
• Train and assist site coordinators, investigators, and CRO staff on data collection and protocol execution.
• Document and communicate site issues, including protocol deviations, adverse events, audits, and overall site performance.
• Identify and resolve site performance, quality, or compliance problems and seek escalation as needed.
• Assist with enrollment and recruitment strategy planning for sites.
• Maintain site/subject visit tracking and documentation in CTMS, eTMF, and other systems.
• Complete routine administrative tasks and study deliverables such as timesheets, metrics, and travel expense approvals.
• Perform additional clinical operations duties as requested, including protocol review, CRA monitoring assessment visits, and co‑monitoring with CRO staff.
• Provide training and mentoring to junior staff and conduct monitoring oversight visits (MOVs) with CRO CRAs.

Qualifications

• BS in biological sciences or a related discipline with at least 5 years of experience as a Clinical Research Associate (or an equivalent combination of education and experience).
• In-depth understanding of study protocols and related procedures.
• Critical thinking, root‑cause analysis, and problem‑solving skills to identify site process failures and develop corrective and preventative actions.
• Ability to motivate site personnel to maintain or accelerate timelines to achieve clinical operational milestones.
• Demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
• Compliance with safety standards and respect for privacy and confidentiality.
• Excellent written, oral, and presentation skills.
• Strong negotiation skills with a tactful approach for value‑based service outcomes.
• Familiarity with current trends in the clinical trial industry.

Preferred Qualifications

• Experience in startup, execution, and close‑out activities related to clinical studies.
• Experience using risk‑based monitoring processes.

Work Environment

• Physical demands include prolonged desk work, intermittent telephone use, keyboard communication, occasional walking, and lifting up to 25 pounds.
• Noise level typically low to moderate.
• Travel may be required for up to 75% of the working time.

Equal Opportunity Employer: Crinetics is proud to provide equal employment opportunities without regard to unlawful considerations of sex, sexual orientation, gender identity, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion, disability, marital and civil union status, age, genetic information, veteran status, or any other protected characteristic under applicable laws.

Salary Range: $119,000–$149,000. Additional benefits include a discretionary annual target bonus, stock options, ESPP, and 401(k) match. Health insurance (medical, dental, vision), 20 days of paid time off, 10 paid holidays, and a winter company shutdown are also provided.