Clinical Research Coordinator 2

Grade: H

FTE: 100%

Stanford Maternal & Child Health Research Institute, on behalf of the Department of Pediatrics, Division of Genetics, is seeking a 6 month fixed term  Senior Clinical Research Coordinator to conduct clinical research and work independently on complex projects/assignments in maternal and child health.

CRC2 must have the ability to implement, organize and conduct all aspects of clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments). S/he will support patients participating in research studies and medical faculty in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients.  Previous clinical research experience is required.  Previous clinical trial experience at Stanford and/or LPCH is highly desirable.

Duties include:

·        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 document 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.

* - Other duties may also be assigned

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. The pay range for this position working in the California Bay area is between $72,000-$92,000.00.

DESIRED QUALIFICATIONS:

• A bachelor’s degree in the biological sciences, medicine or public health is highly desired
• Excellent oral and written communication skills
• Experience with managing clinical data in a research setting
• Proficiency in using computers, software, and web-based applications in a previous administrative setting
• Experience training, mentoring, and/or supervising others on topics related to clinical research conduct and management

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 disease and infections.

·        Position may require being on-call and/or require weekend, extended or unusual work hours based on research requirements and business needs.

·        Position may at times require the employee to support studies that are conducted at off-site clinics (within a 50-mile radius of the main campus).  Incumbent may need to provide own transportation with the ability to get to/from these off-site clinics.

·        Position may at times require the employee to air travel to certain destinations (domestic and international, as needed) in order to participate in research-related events such as Investigator Meetings.

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 bases 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.

~ All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. ~