Clinical Research Coordinator Associate (12-Month Fixed-Term)

The Department of Medicine (DoM) Clinical Research Hub (CRH) at Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies in the disciplines of Nephrology, Hospital Medicine and other therapeutic areas. This role will work in both inpatient and outpatient settings on a variety of interventional and observational clinical research trials and studies. This is an onsite role, with direct patient contact being a primary responsibility. The ability to coordinate moderately complex aspects of one or more clinical studies, ability to task switch in a high-energy environment, outstanding communication and organizational skills, and attention to detail are required in a successful candidate. The CRCA will present updates at study meetings and huddles, and be responsible for ensuring compliance with federal, state, local, institutional and sponsor regulations; and work under close direction of the principal investigator and/or study coordinator/supervisor. Other duties may also be assigned.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• 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.
• Ensure compliance with research protocols, and 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 monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• 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.

DESIRED QUALIFICATIONS:

• Knowledge of the principles of clinical research and federal regulations.
• Familiarity with IRB guidelines and regulations.
• Previous experience with clinical trials.
• Previous experience with database applications.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or 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.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

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:

Occasional evening and weekend hours.

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 $34.56 to $40.30 per hour.

Stanford University provides pay ranges representing its good faith estimate of the hourly wage the university reasonably expects to pay for a position upon hire. 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.

Additional Information

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Fixed-Term
• Grade: F
• Requisition ID: 109005
• Work Arrangement : On Site