Cancer Clinical Research Project Manager – Data Quality and Study Start-Up

🔍 School of Medicine, Stanford, California, United States

New

📁: Research

📅   : 5 days ago Post Date

📅   : 105463 Requisition #

Cancer Clinical Research Project Manager – Cutaneous Lymphoma (Remote Work Agreement)

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. Given the SCI's mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute. The vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.

We seek a Cancer Clinical Research Project Manager (CCRPM) to help us enact our mission to reduce cancer mortality through comprehensive cancer research, treatment, education, and outreach. Our CCRPM will provide oversight for data management integrity and study start-up process across a cancer clinical research group. They will independently manage significant and key aspects of clinical research study data entry, data analysis, and training of team members for all aspects of data quality. This position collaborates closely with physician investigators and clinical research staff to drive successful implementation of cancer clinical trials. Responsibilities include working with the research team(s), clinical staff, and Stanford Health Care departments to support conduct of safe and compliant clinical research.

Reporting to the Lymphoma Clinical Research Manager (CRM), the CCRPM will be conversant in the goals, mission, and priorities of the Institute, and utilize this knowledge to ensure the safety and well-being of trial participants. We seek candidates with excellent interpersonal skills and attention to detail. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative, and flexibility.

Duties include*:

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, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
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.
Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

Knowledge of clinical trials data management, clinical quality management, and study start up processes.
Clinical knowledge in the field of Lymphoma.
Knowledge of various projects and implementation strategies.

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.

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:

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 $84,856 to $97,021 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 (https://cardinalatwork.stanford.edu/benefits-rewards) 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.

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 by submitting 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.

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.

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