"Clinical Research Coordinator Associate (CRCA)"

Stanford University is seeking a Clinical Research Coordinator Associate (CRCA) who also has research laboratory experience to work onsite and perform duties related to the use of biologics in orthopedic surgery. The primary responsibility of the CRCA will be to support the PI in developing and maintaining an Orthobiologics Registry for the Department of Orthopedic Surgery with accompanying biorepository for quality control and assessment of patient outcomes after receiving biologic treatments. The CRCA will assist the PI by serving as a liaison with internal and external stakeholders involved in the Orthobiologics registry. The CRCA will assist with completing administrative requirements and obtaining all necessary regulatory approvals. The CRCA will also enter patients into the registry, obtain consent for biosample collection, perform laboratory processing, analyses and banking of biosamples, and perform follow-up and retention activities.

The ideal candidate is personable, thrives in a collaborative environment, possesses excellent verbal and written communication skills, and demonstrates strong attention to detail and achieving excellence. This role requires someone who can work independently, manage daily responsibilities with minimal supervision, and proactively take initiative. This full-time position is based in Redwood City but requires travel to sports facilities on campus and to research laboratories. To learn more, go to: https://med.stanford.edu/ortho.html

Duties include:

• Serve as primary contact with registry and research participants, sponsors, stakeholders and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from registry and study participants according to protocol. Assist in developing and implementing recruitment and retention strategies.
• Collect, process, analyze and bank study specimens using good laboratory practices according to laboratory protocols.
• Collect, analyze, and manage patient and laboratory data, supplies, and equipment. Manage research project databases, develop flow sheets, spreadsheets,and other study related documents.
• 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.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• BA/BS degree in a science-related field.
• Excellent phone and in-person communication skills.
• General understanding of scientific theory and methods.
• Experience with Redcap and EPIC.
• Ability to work under deadlines with general guidance.
• Excellent organizational skills and demonstrated ability to complete detailed work accurately.
• Prior laboratory experience with cell culture, proteomic analyses, and biospecimen collection and banking.

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.

The expected pay range for this position is $34.56 to $40.30 per hour.