"Clinical Research Coordinator Associate (CRCA)"

The Division of Cardiovascular Medicine is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our division is driven by over 40 faculty, clinician educators and instructors who are the pillar of strength in the Division’s ongoing efforts into the prevention, and treatment of cardiovascular disease.

Under the guidance of the Research Nurse Manager, who supports the Principal Investigator (PI) overseeing the protocols, we are looking for a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and dedicated to making a meaningful impact for patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM). The CRCA will provide support for multiple projects involving participants who have heart failure and/or coronary artery disease.

Key responsibilities include assisting the Research Team during patient visits, determining participant eligibility, administering questionnaires and six-minute walking tests, entering patient data into sponsor platforms, and participating in monitoring visits.

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.
• 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:

• Bachelor's degree in a related field or an equivalent combination of related education and relevant experience; additional 1-2 years clinical trial experience 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:

• 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 diseases and infections.
• Will be working at locations Stanford Boswell Clinics.

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