Lead Clinical Research Coordinator
The Stanford Center for Clinical Research (SCCR), in collaboration with the Stanford Departments of Medicine and Radiology, is conducting one of the largest, most innovative longitudinal studies in association with a leading Silicon Valley tech company and multiple high-profile academic partners. SCCR is seeking to hire multiple Lead Coordinators to support this exciting new study involving multiple disciplines including cardiology, oncology and primary care.
SCCR provides infrastructure and research support to clinical research investigators and staff throughout the department. Its mission is to promote high-quality, globally impactful clinical research to improve human health by working collaboratively within Stanford University and its affiliates.
The Lead Coordinator will work in a dynamic atmosphere and as part of a large team in a supportive environment. The role will be responsible for supporting multiple staff members, including coordinators and research assistants, physicians, nurses, respiratory therapists, and ophthalmic technicians. The Lead Coordinator will direct the operational logistics, ensure efficient participant flow, manage recruitment pipelines, oversee regulatory compliance, and ensure overall logistical progress on the project. The position will interface with faculty, collaborators, and SCCR senior leadership to report project progress and trouble shoot barriers. Outstanding communication and organizational skills, the ability to proactively manage challenges, and strong attention to detail are required in a successful candidate.
Duties include:
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.
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.
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
Manage resources within study budget, working with senior staff and principal investigators, 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.
Ensure Institutional Review Board renewals are completed.
- Other duties may also be assigned
Qualifications:
Excellent leadership and management skills, including several years as a supervisor, mentor, or trainer
Experience with large, complex, longitudinal research studies is desired
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. A Nursing license is valued, but not required
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 disease and infections.
May require extended or unusual work hours based on research requirements and business needs.
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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
SCCR provides infrastructure and research support to clinical research investigators and staff throughout the department. Its mission is to promote high-quality, globally impactful clinical research to improve human health by working collaboratively within Stanford University and its affiliates.
The Lead Coordinator will work in a dynamic atmosphere and as part of a large team in a supportive environment. The role will be responsible for supporting multiple staff members, including coordinators and research assistants, physicians, nurses, respiratory therapists, and ophthalmic technicians. The Lead Coordinator will direct the operational logistics, ensure efficient participant flow, manage recruitment pipelines, oversee regulatory compliance, and ensure overall logistical progress on the project. The position will interface with faculty, collaborators, and SCCR senior leadership to report project progress and trouble shoot barriers. Outstanding communication and organizational skills, the ability to proactively manage challenges, and strong attention to detail are required in a successful candidate.
Duties include:
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.
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.
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
Manage resources within study budget, working with senior staff and principal investigators, 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.
Ensure Institutional Review Board renewals are completed.
- Other duties may also be assigned
Qualifications:
Excellent leadership and management skills, including several years as a supervisor, mentor, or trainer
Experience with large, complex, longitudinal research studies is desired
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. A Nursing license is valued, but not required
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 disease and infections.
May require extended or unusual work hours based on research requirements and business needs.
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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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