"Clinical Research Coordinator Associate (6-month fixed-term)"

The Division of Cardiovascular Medicine, within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease.

We are seeking a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and wants to deliver results. The CRCA will work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Associates and other stakeholders in support of patients with heart disease.

The Clinical Research Coordinator Associate will be responsible for the overall implementation of an assigned set of research protocols assuring efficiency and regulatory compliance. Other responsibilities will include recruiting, screening, assisting in the informed consent process and enrolling subjects in accordance with good clinical practice guidelines as well as collecting, recording and maintaining complete data files using good clinical practice in accordance with HIPAA regulations. The CRCA will participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. Other duties may include processing of blood samples, reporting serious adverse events and maintenance of drug accountability, supplies and equipment.

CV Med Clinical Research is a growing, dynamic team which is dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. If you are eager to quickly achieve lasting results, we invite you to join our team!

This is a six-month fixed-term position.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up 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:

• 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 and cooperatively 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.

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:

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

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

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