Clinical Research Operation Specialist
The Stanford Center for Clinical Research (SCCR) is an Academic Research Organization within the Stanford Department of Medicine that has the mission to innovate, support and promote high impact global reaching clinical research to improve human health. SCCR leverages the physical and intellectual resources of Stanford University and its affiliated teaching hospitals and research centers to achieve this mission.
The Stanford Center for Clinical Research is seeking a Clinical Research Operations Specialist II to conduct and manage multi-site clinical trials. Research will be conducted in a variety of therapeutic areas including but not limited to cardiovascular, neurology and pulmonary. The Clinical Research Operations Specialist II will be responsible for the management of 3 to 25 research sites for one or more studies by ensuring adequate study start up, regulatory submissions and training of each of the study sites in preparation for site activation. This position will be the main point of contact for the study sponsor and the study PI. This position will assist in the management of the entire study from startup to closeout and will ensure that regulatory requirements are adhered to.
- Oversee subject recruitment and study enrollment goals for all sites. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term multi-site clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection.
- 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, 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 principal investigator and sponsor. Track deliverables 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
- Demonstrated superb communication skills in speaking and writing
- Multi-site clinical trial management experience
- Project management experience
- 2-4 years of clinical research experience is a plus
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 disease and infections.
- May require extended or unusual work hours based on research requirements and business needs.
- 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 bases 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, http://adminguide.stanford.edu.
Job Family: Research
Job Series: Clinical Research Coordinator
Job Code: 4923