Clinical Research Coordinator Associate - ID/Gilead
dev2
Stanford, CALIFORNIA, us
Posted Dec 11, 2023
- Full-time
- Other
Job description
The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health. At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply! In collaboration with the Division of Infectious Diseases and others at Stanford, SCCR is seeking 2 Clinical Research Coordinator Associates (CRCAs) to work on a highly impactful COVID-19 study, including but not limited to treatment trial for COVID-19. The CRCAs will work under a CRCII to recruit and enroll participants and monitor research participant workflow to ensure study visit completion. The CRCAs will coordinate all aspects of the study visits and work in a dynamic atmosphere and as part of a large team in a supportive environment. There will be the opportunity to work closely with fellow coordinators and research assistants, physicians, nurses, and technicians. Direct patient contact is a primary responsibility of these roles. The CRCAs are required to have the ability to multi-task in a high-energy environment. A flexible work schedule, outstanding communication and organizational skills, and attention to detail are required in successful candidates. The CRCAs will act as point of contacts for participants and staff, present at meetings and huddles, and troubleshoot research related issues. The CRCAs will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work under the direction of their supervisor/s. The CRCAs will work under close direction of the principal investigator and/or study coordinator/supervisor. Other duties may also be assigned. This is an on-site position. Duties include: Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS: Clinical research coordinator experience. Clinical research operations certificate or interest in working toward one. Valid CA driver's license. EDUCATION & EXPERIENCE (REQUIRED): Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong interpersonal skills. Proficiency with Microsoft Office. Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG. PHYSICAL REQUIREMENTS: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORKING STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide,