Clinical Research Coordinator
5 days left
- Full Time
Stanford’s Division of Reproductive Endocrinology and Infertility (REI) within the Department of Obstetrics & Gynecology is seeking an experienced Clinical Research Coordinator 2 to lead the REI clinical research operations and work independently on progressively more complex projects/assignments. The successful Clinical Research Coordinator 2 candidate will independently manage significant and key aspects of multiple NIH and industry funded infertility research studies and oversee the work of junior research staff.
- Oversee subject recruitment and study enrollment goals.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects.
- Develop and manage systems to organize, collect, report, and monitor data collection.
- Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and accountabilities, as assigned.
- Lead team meetings and prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
- Monitor Institutional Review Board submissions, and respond to requests and questions.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- Develop study budget with staff and principal investigator, identifying standard of care versus study procedures.
- Track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance.
- Regularly inspect study document to ensure ongoing regulatory compliance.
- Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable.
- Ensure Institutional Review Board renewals are completed.
* - Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills
- Proficiency with Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
CERTIFICATIONS & LICENSES:
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License.
- 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.
- 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.
Job Code: 4923
Employee Status: Regular
Requisition ID: 84968