Clinical Research Manager 2

Stanford University; Palo Alto (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Stanford University’s Department of Neurosurgery seeks an experienced Clinical Research Manager with a combined medical and surgical background to lead and coordinate clinical research operations across medical and surgical specialties. This full-time role oversees complex projects, supervises staff, and ensures regulatory compliance and fiscal oversight in an academic medical center setting.

The successful candidate collaborates with faculty investigators, clinical teams, and research staff to

Qualifications

• Direct clinical experience in both medical settings (inpatient/outpatient) and surgical settings (OR, PACU)
• Master's degree in clinical research, public health, nursing, or related field
• Experience with NIH-funded research including grant preparation and progress reporting
• Publication record in peer-reviewed journals
• Experience with medical device trials and pharmaceutical trials across multiple phases
• Familiarity with translational research bridging basic science and clinical applications
• Knowledge of comparative effectiveness research and implementation science
• Experience with patient-reported outcomes and quality of life assessments

Responsibilities

• Select, develop, and evaluate personnel to ensure efficient operations and staffing for programs; mentor staff.
• Audit operations to ensure quality and compliance; lead inspections or audits.
• Oversee participant recruitment and retention; develop regulatory documents including consent forms.
• Make strategic decisions on new and existing clinical research projects; chair committees as needed.
• Develop research goals for trials in collaboration with faculty and stakeholders.
• Oversee regulatory management and resolve compliance issues across programs.
• Ensure compliance with local, federal, and international regulations; drive process improvements.
• Manage program budgets and track financial status; develop study budgets.
• Engage in outreach and represent the program to internal and external audiences.
• Analyze recruitment trends; standardize reporting and improve processes and tools.
• Contribute to data analysis and prepare manuscripts and scientific presentations

Skills

Clinical research management

Medical background

Surgical background

NIH grant experience

Publication record

Regulatory compliance

Staff supervision

Cross-disciplinary collaboration

Education

Master's degree in clinical research

Bachelor's degree in related field

Tools

REDCap Cloud

EPIC

Microsoft Office

Database applications

Job description

The Department of Neurosurgery seeks an experienced Clinical Research Manager with combined medical and surgical background to lead and coordinate clinical research operations across medical and surgical specialties. This position will provide leadership and oversight of complex clinical research projects, supervise multiple clinical research staff, and manage all aspects of clinical research operations including quality management, personnel management, regulatory compliance, and fiscal oversight.

The successful candidate will work collaboratively with faculty investigators, clinical teams, and research staff to ensure the successful execution of diverse research portfolios spanning medical and surgical disciplines. This role requires expertise in both medical and surgical clinical environments, strong leadership abilities, and a commitment to maintaining the highest standards of research quality and regulatory compliance.

This is a full-time, benefits-eligible position offering competitive compensation and comprehensive benefits in an academic medical center setting with opportunities for professional growth and scholarly activity.

DESIRED QUALIFICATIONS

• Direct clinical experience in both medical settings (inpatient/outpatient units, specialty clinics) and surgical settings (OR, PACU, surgical units).
• Master's degree in clinical research, public health, nursing, or related field.
• Experience with NIH-funded research including grant preparation and progress reporting.
• Publication record in peer-reviewed journals.
• Experience with both medical device trials and pharmaceutical trials across multiple phases.
• Familiarity with translational research initiatives bridging basic science and clinical applications.
• Knowledge of comparative effectiveness research and implementation science methodologies.
• Experience with patient-reported outcomes and quality of life assessments.

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

• May be exposed to blood borne pathogens.
• May be required to work non-standard, extended or weekend hours in support of research or project work.

WORK STANDARDS

• 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.
  

Responsibilities

Core Duties

• Select, develop, and evaluate personnel to ensure efficientoperations, including hiring, performance management, and relatedduties. Oversee staffing and overall resourcing for program(s) underpurview. Mentor Clinical Research Managers.

• Audit operations to ensure effective implementation of internalprocesses and quality program. Provide leadership in identifying andimplementing corrective actions/processes. Lead inspections oraudits.

• Oversee development of effective participant recruitment andretention activities. Oversee development of regulatory documents,including consent forms, for studies.

• Make strategic decisions regarding new and existing clinicalresearch projects that may impact resourcing, quality, safety and/orcompliance of program(s) under purview. Lead or chair committees or taskforces to address and resolve significant issues.

• Develop and/or implement research goals for a clinical trial(s)/therapeutic program in collaboration with multiple faculty members andinternal/external stakeholders.

• Oversee regulatory management of programs and troubleshootcomplex regulatory issues. Mentor and train managers and staff on how toresolve compliance issues and regulatory challenges acrossprograms/organizations.

• Provide oversight and guidance on compliance with local, federaland international regulations on clinical research conduct. Lead processand quality improvement initiatives to ensure efficiency inimplementation of new protocols.

• Manage and track research program financial status with regularreports to research leaders. Oversee development of appropriate studybudgets that meet the needs of the research program.

• Engage in high-level outreach and networking opportunities in aprogram leadership capacity, representing the research program to avariety of internal and external audiences.

• Analyze trends in recruitment across the portfolio, develop andmonitor use of standardized reporting of key metrics. Develop ideas andimplement improved processes and tools to ensure program success andcompliance.

• Contribute to analysis of data and preparation of manuscripts andscientific presentations.

Minimum Education

Bachelor's degree in related field

Minimum Experience

Five years of experience in clinical research, or an equivalentcombination of education and relevant experience. Master's degreepreferred.

Knowledge, Skills and Abilities

• Excellent interpersonal skills.

• Excellent diplomacy skills

• Proficiency in Microsoft Office and database applications, andEHRs (i.e., REDCap Cloud, EPIC).

• Experience with research protocols and regulatory or governingbodies, which include HIPAA and FDA regulations, Institutional ReviewBoard requirements, and Good Clinical Practices.

• Knowledge of medical terminology.

• Minimum of three years of demonstrated managerialexperience.

• Demonstrated disease knowledge / study design experience ofstudies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of ClinicalResearch Professionals certification is preferred.