Senior Clinical Research Associate (Central Region)

Role Summary

The Senior Clinical Research Associate (Sr. CRA) participates 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, and monitors trials in accordance with Good Clinical Practices and Crinetics procedures. May participate in monitoring oversight activities and CRO-related reviews.

Responsibilities

• Develop strong, collaborative investigational site relationships and maintain continuity through all stages of the trial.
• Perform clinical study site management/monitoring activities in compliance with GCP/ICH, SOPs, local laws, protocol, and monitoring plans.
• Participate in site selection and site qualification activities.
• Coordinate and manage assigned tasks with the study team to achieve site activation.
• Perform remote and on-site monitoring to protect subject rights, safety, and data integrity.
• Conduct site visits (qualification, initiation, interim monitoring, close-out); generate visit reports and letters promptly.
• Review and verify study records to ensure data accuracy and completeness.
• Interact with sites to resolve data queries and obtain information on potential serious adverse events.
• Assess investigational product receipt, storage, accountability, and return processes.
• Collect, review, and monitor essential regulatory documentation for start-up, maintenance, and close-out.
• Submit essential documents to the TMF; resolve quality issues related to submitted documents.
• Train and assist site staff in data collection and study execution; serve as a resource on products and protocols.
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, adverse event reporting, audits, and site performance.
• Identify and resolve site performance, quality, or compliance problems and escalate per escalation pathways with CTM/Clinical Monitoring management.
• Assist in developing and implementing subject enrollment and recruitment strategies.
• Manage and maintain visit information in CTMS/eTMF and other systems.
• Complete routine administrative tasks and ensure training per study timelines; ensure study deliverables are met.
• Perform other Clinical Operations duties as requested.

Qualifications

• BS in biological sciences or related discipline with at least 5 years of Clinical Research Associate experience (or equivalent combination of experience and education).
• Strong understanding of study protocols and procedures.
• Analytical and problem-solving skills to identify site process issues and implement corrective actions.
• Ability to motivate clinical site personnel to meet timelines and milestones.
• Knowledge of Good Clinical Practices, ICH Guidelines, and regulatory requirements; commitment to safety, privacy, and confidentiality.
• Excellent writing, communication, and presentation skills; strong interpersonal skills.
• Negotiation skills and ability to secure high-value outcomes.
• Awareness of current trends in the clinical trial industry.

Preferred

• Experience with startup, execution, and close-out of clinical studies; risk-based monitoring experience preferred.

Skills

• Clinical trial monitoring
• Site management and QA
• Regulatory documentation
• CTMS/eTMF proficiency
• Communication and training

Education

• BS in biological sciences or related field (required as per qualifications).

Additional Requirements

• Travel up to 75% of time.
• Physical demands: occasional lifting up to 25 lbs and long periods of desk work; standard office environment.