From Stanford University's posting. “We” and “our” refer to the employer.
Clinical Research Coordinators (CRCs) support, conduct, coordinate or manage the clinical research studies or trials on human subjects. Principal and co-investigators provide the overall direction in a clinical study, but CRCs can have significant roles in clinical study activities.
The Keller Lab in Psychiatry and Behavioral Sciecn at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.
The Keller Labs goal is to understand the fundamental principles of human brain plasticity and build trans-diagnostic real-time monitoring platforms for personalized neurotherapeutics.
We use an array of neuroscience methods to better understand the basic principles of how to create change in brain circuits. We use this knowledge to develop more effective treatment strategies for depression and other psychiatric disorders.
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. 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
DESIRED QUALIFICATIONS:
Experience independently coordinating multiple concurrent clinical research studies, including participant recruitment, study scheduling, and research operations.
Experience conducting clinical assessments to screen and recruit participants with major depressive disorder (MDD).
Experience with clinical trial management, including IRB submissions, regulatory documentation, and study reporting requirements.
Experience with transcranial magnetic stimulation (TMS), electroencephalography (EEG), magnetic resonance imaging (MRI), functional MRI (fMRI), or other neuroscience research methods.
Experience managing research data using REDCap or similar databases; familiarity with behavioral or electrophysiological data analysis.
Experience training, mentoring, or supervising clinical research staff.
Strong organizational, communication, and problem-solving skills, with the ability to coordinate across investigators and research teams.
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.
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.
Additional PHYSICAL REQUIREMENTS: (remove if none)
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.
Qualifications
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APPLICABLE. REMOVE IF NOT APPLICABLE]
Drivers License Requirements
Must possess and maintain a valid California non-commercial Class
C Driver's License.
Ability to drive day or night.
When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.
Responsibilities
Core Duties: 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 documents 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.
Minimum Education and Experience
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: Strong interpersonal skills.
Proficiency in 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.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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