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

The Department of Orthopaedic Surgery boasts a prominent national and international presence in orthopaedic research, representing a wide range of subspecialties within the field. This research encompasses treatments for musculoskeletal issues in patients spanning from infants to older individuals. The overarching goal of the Orthopaedic Research Program is to cultivate foundational knowledge that propels the advancement of musculoskeletal injury and disease treatments.

To further this mission, the department is seeking a dedicated Clinical Research Coordinator Associate (CRCA) to oversee clinical studies within the Pediatric division. This position coordinates moderately complex aspects of the clinical studies and works under close direction of the Pediatric Orthopaedic's principal investigator and/or study coordinator. This is a 1-Year Fixed Term position located on main campus. The ideal candidate will serve as the primary point of contact for the study participants and be motivated to support a cohesive and mission driven team of faculty and staff that are advancing the field of Orthopaedic Surgery. To learn more about the Department please visit us at: https://ortho.stanford.edu/.

The successful candidate will demonstrate:

• Excellent communication and relationship building skills;
• Strong attention to detail and commitment to uphold regulatory compliance; and
• Drive to establish themselves as a leading contributor within the Department of Orthopaedic Surgery.

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 investigators (PIs) regularly, ensuring patient safety and adherence to proper study conduct.
• Clearly communicate to PIs and research team regarding project status and any issues/barriers to project implementation.
• Interact with lead biostatistician regularly, ensuring proper study implementation and data management.
• Meet with PIs and lead biostatistician regularly to refine project prioritization.
• Juggle multiple open research projects while meeting deadlines for deliverables.
• Responding to team communications (email, phone) in a timely and accurate manner.
• 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.

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.

* - 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: Occasional evening and weekend hours.

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 $34.56 to $40.30 per hour. Stanford University provides pay ranges representing its good faith estimate of the salary or 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: 109084
• Work Arrangement : On Site