Clinical Research Coordinator 2
Clinical Research Coordinator 2
Job Number: 87532
The Stanford Stroke Center in Stanford University's School of Medicine is seeking a Clinical Research Coordinator 2 (CRC2) to provide leadership and oversight, and to independently manage significant and key aspects of multiple complex clinical research projects and supervise 2-6 CRCAs for StrokeCog within the Stanford Stroke Recovery Program.
The Stanford Stroke Center is a highly productive stroke and neurocritical care research center consisting of 11 faculty members and 7 research coordinators. The Stroke Center currently conducts multiple clinical trials in the acute, sub-acute and outpatient settings, encompassing acute intervention, diagnosis, observational, prevention and recovery trials. This CRC2 will report to the Program Manager and work closely with the Stroke Recovery Program faculty/physician leaders. The selected candidate must have the ability to implement, organize and conduct all aspects of clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments).
S/he will support patients participating in research studies and medical faculty in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research experience is required. Previous clinical study experience at Stanford and/or LPCH is highly desirable. The CRC2 will be responsible for the implementation of assigned studies and clinical trials and there is an option to participate in the shared research coordinator call schedule for all stroke trials. S/he will also provide coverage for other members of the research team, and attend relevant departmental meetings.
- Oversee the team of clinical coordinators, and all the studies in the Stanford Stroke Recovery Program. This includes oversight of subject recruitment and study enrollment goals, and may include directly recruiting subjects as well as supervising CRCAs.
- Coordinate with study leaders at other sites.
- 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 and interact with data analysts. Ability to use and program RedCap databases is desirable.
- 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
This CRC2 should have substantial prior experience with clinical trials and an aptitude for supervision. Experience with, or training in performing cognitive testing, or on other long-term prospective cohort studies is also desirable.
EDUCATION & EXPERIENCE (REQUIRED):
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 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 will 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.
- Schedule: Full-time
- Job Code: 4482
- Employee Status: Regular
- Grade: G
- Requisition ID: 87532
Location: School of Medicine, Stanford, California, United States
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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