Senior Clinical Research Associate

March 15

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Crinetics Pharmaceuticals

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Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

Drug Discovery • Endocrinology • RareDisease • Biotech

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Participate in the preparation and execution of Phase 1-3 clinical trials • Oversee the progress of clinical investigations by conducting site qualification, initiation, interim, and close-out visits • Monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by Crinetics Pharmaceuticals and partner CRO(s) • Work closely with the Clinical Trial Manager and Clinical Monitoring management to ensure all monitoring activities are conducted according to study requirements • 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 • Conduct site visits including qualification, initiation, interim monitoring, 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 the 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 • Communicate and document contacts with investigators and site staff regarding 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 • Assist in the development and implementation of subject enrollment and recruitment strategies for the site • Manage and maintain visit information such as site/subject visit tracking and other documentation in the Clinical Trial Management System (CTMS), Trial Master File (eTMF), and other systems

🎯 Requirements

• BS in biological sciences or related discipline with at least 5 years of experience in the role of Clinical Research Associate • 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 • Ability to motivate clinical site personnel to compliantly maintain/accelerate timelines • 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 lead to high value on services obtained and outcomes achieved • Well-versed with the latest trends in the clinical trial industry • Monitoring experience in startup, execution and close-out activities related to clinical studies preferred

🏖️ Benefits

• discretionary annual target bonus • stock options • ESPP • RSUs • 401k match • 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 • winter company shutdown