Assistant Clinical Research Coordinator

at  Stanford University

Fixed 6-month term
Stanford University’s Pediatric Vascular Laboratory, led by Dr. Seda Tierney, is seeking a part-time (50% FTE) Assistant Clinical Research Coordinator to perform duties related to the coordination of clinical studies. We are looking for highly motivated candidates excited by the opportunity to take ownership of projects that will advance medical knowledge and clinical practices.

The ACRC will coordinate, with the opportunity to lead, moderately complex aspects of one or more clinical studies. This is an onsite role with studies conducted at Lucille Packard Children’s Hospital. The ACRC will work under the close direction of the principal investigator and study supervisor. The position requires the ability to work in a fast-paced environment, patience and resourcefulness to interact well with individuals and their families, and organization skills to balance multiple timelines.

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies and conduct necessary testing from startup through close-out.
• Manage 2-3 studies simultaneously, including the RE-ENERGIZE FONTAN study and related vascular

lab projects. May lead collaborating studies.

• Schedule and ensure proper protocol implementation of studies. Conduct vascular lab testing outlined by their respective protocols.
• Handle regulatory compliance (IRB protocols, consent forms, renewals, revisions). Regularly update the regulatory binder with the PI.
• Prepare, administer, and score study questionnaires and tests. Review forms and measurements for

accuracy and completeness.

• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Help identify, screen, recruit, consent, and enroll participants. Assist in devising strategies to hit target recruitment numbers, including overseeing the use of gift cards as reimbursements or incentives for subject visits. The RE-ENERGIZE FONTAN study target enrollment is 150 patients over 4.5 years.
• Collect, process, and ship study specimens.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study-related documents, and complete study documents/case report forms.
• Enter data and make modifications to the database as needed.
• Extract and prepare data from REDCap for the Statistical Team that will do the analysis.
• Ensure compliance with research protocols, review and audit case report forms for completion and accuracy with source documents, prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend

and present at monitoring meetings with sponsors, acting as primary contact.

• Ensure that the technological devices in the study are compliant and backed up.
• Organize the exercise trainers’ and participants’ workout schedules to meet their needs and ensure the exercise protocol is followed.
• Attend all the monitoring meetings, present recruitment updates, and prepare agendas, minutes, and necessary tables.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Review hospital research billing documents.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Assist with the onboarding of a new team member.
• Meet weekly with the PI to review and present recruitment numbers, significant study-related events, upcoming milestones, etc., to ensure that study targets are continuously met.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Other duties may also be assigned

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.
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 $25.48 to $31.25 per hour.

Qualifications:

• Meticulous, responsible, detail-oriented, able to multi-task, and solution-oriented.
• Prior experience with consent/assenting and interviewing research subjects is a plus.
• Have the necessary patience and resourcefulness to interact well with individuals and their families.
• Comfortable interacting with patients/participants.
• Able to organize and balance multiple projects at one time.

EDUCATION & EXPERIENCE (REQUIRED):

Two years of a college degree, two years of related work experience, a bachelor’s degree in a related field, or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Strong oral and written communication skills.
• This is an onsite position.
• Attention to detail and ability to multi-task.
• Proficiency in technology, including Zoom, Microsoft Word, Excel, and PowerPoint.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
• Experience with RedCAP database.
• Manual dexterity and ability to perform effectively under pressure.
• Fluency in Spanish (optional).

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.

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies and conduct necessary testing from startup through close-out.
• Manage 2-3 studies simultaneously, including the RE-ENERGIZE FONTAN study and related vascula