Clinical Research Manager
6 days left
- Full Time
Stanford University Department of Obstetrics & Gynecology is seeking a Clinical Research Manager to provide leadership and oversight of the Maternal-Fetal Medicine/Obstetrics research operations team. The Division of Maternal-Fetal Medicine and Obstetrics is engaged in a spectrum of research covering early pregnancy and placentation; prenatal diagnosis and fetal therapy; from translational research to clinical trials and population based cohort studies. We are actively engaged in several national collaborative trials, including studies sponsored by the National Heart Lung and Blood Institute (NHLBI) and National Institute of Child Health and Human Development (NICHD). Our division is also a part of the North American Fetal Therapy Network (NAFTNet).
The Maternal-Fetal Medicine/Obstetrics Clinical Research Manager will oversee multiple medium to small size federally funded and sponsored clinical research projects that vary in their complexity. The successful candidate will have an opportunity to supervise multiple clinical research staff, collaborate with external sponsors and variety of investigators and work in a dynamic environment. Exceptional interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.
At the Department of Obstetrics & Gynecology, our mission is to improve women’s health through innovative and compassionate care, education, advocacy and discovery – more details at obgyn.stanford.edu. If you are interested in being a part of this innovative and dynamic team, we encourage you to apply!
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
- Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
- 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 and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
- Lead or chair committees or task forces to address and resolve significant issues.
- Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
- Assist with analysis of data and preparation of manuscripts and scientific presentations.
* - Other duties may also be assigned
- Superb written and verbal communication skills.
- Proven track record in personnel/team management and team building.
- Clinical knowledge in the field of Obstetrics & Gynecology and/or Maternal-Fetal Medicine.
- Knowledge of various projects and implementation strategies.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent 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.
- Demonstrated managerial experience.
CERTIFICATIONS & LICENSES:
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- 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 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.
- 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.
- Schedule: Full-time
- Job Code: 4926
- Employee Status: Regular
- Grade: J
- Department URL: http://obgyn.stanford.edu
- Requisition ID: 87065