Senior Clinical Research Associate - EAST COAST

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).

Essential Job Functions And 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 efficiently in compliance with GCP/ICH requirements, SOPs, local laws and regulations, protocol, Clinical Monitoring Plan, and associated documents.
• Participate and provide input on site selection and site qualification activities.
• Collaborate with the study team to manage assigned tasks to achieve site activation.
• Coordinate and manage remote and on-site monitoring activities using various tools to ensure subject rights, safety, and well-being are protected as well as the reliability and integrity of study data.
• Conduct site visits including qualification visits, initiation visits, interim monitoring visits, and close-out visits; generate clear, comprehensive, and accurate visit reports and letters in a timely manner.
• Review and verify study records including source documents, case report forms, informed consent forms and other materials to ensure data is complete and accurate.
• Interact with the clinical study sites to resolve data queries and/or data entry errors and obtain additional information on potential serious adverse events.
• Absess and monitor investigational product receipt, storage, administration, accountability and return processes.
• Collect, review, and monitor essential regulatory documentation maintained by the site for study start-up, study maintenance, and study close-out.
• Submit site essential documents to the TMF following inline quality review and resolve any quality issues related to submitted documents.
• Train and assist site coordinators, investigators, and CRO (as applicable) in collecting data and executing the study in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols.
• Communicate and document contacts with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, adverse event reporting, site audits/inspections, and overall site performance.
• Identify, assess, and resolve site performance, quality or compliance problems and escalate as needed per defined escalation pathway in collaboration with CTM and/or Clinical Monitoring management.
• Assist in the development and implementation of subject enrollment and recruitment strategies for site.
• Manage and maintain visit information such as site/subject visit tracking and other documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and other systems.
• Ensure internal and study-related trainings are completed per study timelines.
• Ensure all study deliverables are completed per Crinetics and study timelines.
• Perform other Clinical Operations duties, as requested.

Required Education and Experience

• BS in biological sciences or related discipline with at least 5 years of experience in the role of Clinical Research Associate (an equivalent combination of experience and education may be considered).
• Demonstrate an in-depth understanding of the study protocol and related procedures.
• Demonstrate critical thinking, root cause analysis and problem solving to identify site process failures; develop corrective and preventative actions to bring sites into compliance.
• Able to motivate clinical site personnel to compliantly maintain/accelerate timelines to achieve clinical operational milestones.
• Understand and demonstrate application of Good Clinical Practices, ICH Guidelines and regulatory requirements.
• Able to comply with safety standards and respect privacy and confidentiality.
• Excellent writing skills as they relate to the preparation of clinical trial documents.
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Able to negotiate effectively and have a tactful approach that leads to high value on services obtained and outcomes achieved.
• Well versed with the latest trends in the clinical trial industry.
• Preferred Monitoring experience in startup, execution and close out activities related to clinical studies; experience using risk-based monitoring processes preferred.

Physical Demands And Work Environment

• On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means.
• Sometimes walk and lift up to 25 lbs.
• The noise level in the work environment is typically low to moderate.

Travel

You may be required to travel for up to 75% of your time.

Equal Opportunity Employer

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary Range

The salary range for this position is: $119,000 - $149,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.