Senior Clinical Research Associate (Central Region)

Role 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, and monitors trials in accordance with Good Clinical Practices and Crinetics procedures.

Responsibilities

• Develop strong, collaborative investigational site relationships and ensure continuity of relationships through all stages of the trial.
• Perform clinical study site management/monitoring activities in compliance with GCP/ICH requirements, SOPs, local laws and regulations, protocol, Clinical Monitoring Plan, and related documents.
• Participate and provide input on 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 well-being and ensure data reliability and integrity.
• Conduct site visits (qualification, initiation, interim monitoring, close-out) and generate clear visit reports and letters in a timely manner.
• Review and verify study records (source documents, CRFs, informed consent, etc.) for completeness and accuracy.
• Interact with clinical study sites to resolve data queries and obtain information on potential serious adverse events.
• Assess and monitor investigational product receipt, storage, administration, accountability, and return processes.
• Collect, review, and monitor essential regulatory documentation maintained by the site for start-up, maintenance, and close-out.
• Submit site essential documents to the TMF, resolve quality issues related to documents.
• Train and assist site personnel in data collection and study execution to meet protocol requirements and timelines.
• Communicate and document contacts with investigators/site staff regarding protocol conduct, recruitment, regulatory documentation, adverse event reporting, site audits/inspections, and site performance.
• Identify and resolve site performance, quality, or compliance problems and escalate as needed with CTM/Clinical Monitoring management.
• Assist in development and implementation of subject enrollment and recruitment strategies.
• Manage visit information and documentation in CTMS, eTMF, and other systems.
• Complete routine administrative tasks (timesheets, metrics, travel expenses, etc.).
• Ensure internal and study-related training is completed per timelines and all study deliverables are met.
• Perform other Clinical Operations duties as requested.

Qualifications

• Required: BS in biological sciences or related discipline with at least 5 years of experience as a Clinical Research Associate (or equivalent combination of experience and education).
• Demonstrated understanding of study protocols and procedures; strong problem-solving and root cause analysis skills.
• Ability to motivate clinical site personnel to maintain/compress timelines and achieve milestones.
• Understanding and application of Good Clinical Practices, ICH Guidelines, and regulatory requirements; commitment to safety and confidentiality.
• Excellent writing, interpersonal, oral/written communication, and presentation skills.
• Strong negotiation skills and ability to achieve high-value outcomes.
• Knowledge of latest trends in the clinical trial industry.

• Preferred: Monitoring experience in startup, execution, and close-out activities; experience with risk-based monitoring processes.

Skills

• Site management and monitoring
• Regulatory documentation and TMF/eTMF management
• Data quality assurance and source data verification
• Communication and cross-functional collaboration
• Training and mentoring others
• CTMS/eTMF proficiency

Education

• BS in biological sciences or related discipline (as listed under Required).

Additional Requirements

• Travel up to 75% of time.