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.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- 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.
- Coordinate and manage assigned tasks in collaboration with the study team to achieve site activation.
- Perform 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 but not limited to 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.
- Assess 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.
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense submissions and approvals as needed).
- 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.
These activities may be performed by the Senior Clinical Research Associate depending on study assignment:
- Review protocols, eCRFs, study manuals and other related documents, as requested by the CTM and Clinical Monitoring management.
- Conduct CRA monitoring assessment visits, as needed.
- Conduct co-monitoring, data collection visits with Crinetics or CRO CRAs, as needed.
- Provide training/mentoring on operational tasks/projects to more junior staff.
- Conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit.
- Review monitoring visit reports from CRO and escalate monitoring trends or findings to the CTM and Clinical Monitoring management.
Education and Experience:
Required:
- 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.
- Ability to motivate clinical site personnel to compliantly maintain/accelerate timelines to achieve clinical operational milestones.
- An understanding and demonstrated 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.
- Excellent negotiation skills and 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:
Physical Activities: 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. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
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.