Clinical Research Coordinator 2

Stanford Reglab; Redwood City (CA); Sur place; USD 75 000 - 95 000; Plein temps

Résumé du poste

Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) to conduct clinical research within the Department of Orthopaedic Surgery. The CRC2 will independently manage recruitment, enrollment across industry-sponsored trials and PI-initiated studies in Sports Medicine, and will implement effective strategies to promote participation and retention in long-term studies.

The role requires strong knowledge of recruitment, screening, informed consent, and regulatory processes; it also

Qualifications

• Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Experience with regulatory requirements including HIPAA, FDA regulations, IRB requirements, and GCP.

Responsabilités

• Oversee subject recruitment and enrollment goals.
• Manage data collection, reporting, and milestone tracking for studies.
• Formally supervise, train, and mentor staff as assigned.
• Audit operations for regulatory compliance and monitor IRB submissions.
• Collaborate with principal investigators and sponsors; monitor adverse events and queries.
• Develop study budgets and invoicing with sponsors; track milestones.

Connaissances

Interpersonal skills

MS Office & databases

Regulatory knowledge (HIPAA/FDA/IRB/Gx

Medical terminology

Formation

Bachelor’s degree in related field

Description du poste

Stanford University’s is seeking a Clinical Research Coordinator 2 (CRC2) to conduct clinical research and work independently on progressively more complex projects/assignments with the Department of Orthopaedic Surgery. The CRC2 will oversee subject recruitment and enrollment across active industry-sponsored clinical trials and PI-initiated studies in Sports Medicine. Working closely with Sports Medicine PIs and CRCAs, the CRC2 develops and implements effective strategies for promoting participation and retaining participants in long-term studies. The CRC2 demonstrates strong working knowledge of the recruitment, screening, chart reviews and informed consent processes and applies this expertise to also support the Sports CRCAs with consistent, compliant enrollment practices. This position will independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

Must possess and maintain a valid California non-commercial Class C Driver’s License. MVR background check 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.
• Ability to drive day or night.

* - 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 diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

WORK STANDARDS:

• When conducting university business, must comply with California Vehicle Code and Stanford University driving requirements.
• 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 based 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.

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.

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.

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.