Clinical Research Coordinator Associate

Clinical Research Coordinator Associate (CRCA) – 6‑month fixed‑term position within Stanford University Department of Medicine, Division of Cardiovascular Medicine. The role supports clinical research efforts in cardiovascular disease, working with Principal Investigators, Clinical Research Managers, Associates and stakeholders to deliver high‑quality research results.

• Serve as primary contact with research participants, sponsors and regulatory agencies. Coordinate studies from start‑up through close‑out.
• Determine eligibility 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 documents, and complete study documents and case report forms.
• 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 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.

• Previous clinical research experience.
• Knowledge of principals of clinical research and federal regulations.
• Familiarity with IRB guidelines and regulations.
• Proven ability to work independently and take ownership of a project.
• Proven ability to work collaboratively andatively in a team environment.
• Ability to work effectively in a fast‑paced environment with multiple projects and timelines.
• Detail oriented with excellent organizational skills.
• Excellent communication skills.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
• Fluency in Spanish is a plus. BLS certification is a plus.

• 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.

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

• Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.

• 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.

• 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.
• May require extended or unusual work hours based on research requirements and business needs.

• 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…