Lead Program Manager (2-Year Fixed-Term)

🔍 School of Medicine, Stanford, California, United States

New

📁: Research

📅   : 4 days ago Post Date

📅   : 106401 Requisition #

The Stanford Prevention Research Center (SPRC) is a consortium of renowned experts who are world leaders in investigating ways to prevent disease and promote health. Their work is focused on identifying the most practical, science-based solutions for addressing some of society's most pervasive and preventable health issues, such as obesity, diabetes, hypertension, and other chronic conditions and to raise the standards of scientific investigation that matters for health. SPRC investigators are collaborating on numerous, long-term projects designed to translate research into effective ways to promote well-being at every stage of life. Located within SPRC and led by Principal Investigator Ann Hsing, PhD, the Hsing Lab focuses on cancer epidemiology and prevention, Asian American health, and well-being research.

The Hsing Lab is seeking an experienced, Clinical Research Manager to be a part of the leadership team that oversees several large ongoing studies, including a large international study of cancer. The successful candidate will be the team lead on recruitment of participants for the study and be the point of contact for collaborating study sites. The CRM will also coordinate across several teams of the study (e.g., specimen team, data team) to ensure the success of the study. The CRM will help oversee data and specimen quality management of study sites, personnel recruitment, train and manage Hsing lab staff who support the study, ensure regulatory compliance (e.g., IRB) for the study, and help with fiscal oversight for the study, in particular the collaborating sites. The ideal applicant should possess exceptional quantitative, analytical, and organizational skills as well as time management and team management skills, and experience with coordinating international studies. Field experience in large population-based studies with biospecimen collection is a plus. Excellent interpersonal, communication, and writing skills are essential for this role. Must be self-motivated, detail-oriented, and able to work independently and collaboratively. Must have outstanding work ethics, be dependable and reliable with meticulous attention to details, precision, and accuracy.

Duties include:

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 to 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.
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.

DESIRED QUALIFICATIONS:

Outstanding organizational skills and time management skills.
Excellent oral and written communication skills.
Experience with population and epidemiologic research designs.
Experience in international collaborations.
Experience with IRB protocols and requirements.
Field work in population studies, data/specimen collection or other areas of specialization, or combination of relevant education, training, and/or experience is a plus.
Advanced degree (e.g, MS, MPH or PhD) in epidemiology or related field with emphasis in cancer prevention.

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.

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.

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.

WORKING 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/.

The expected pay range for this position is $120,411 to $143,265 per annum.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Why Stanford is for You
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
Discovery and fun. Stroll through historic sculptures, trails, and museums.
Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at stanfordelr@stanford.edu. For all other inquiries, please submit a contact form.

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

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