Clinical Research Coordinator Associate
6 days left
- Full Time
Stanford University ‘Maternal & Child Health Research Institute’, on behalf of the Department of Pediatrics, Division of Gastroenterology Medicine, is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies. The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under the general direction of multiple principal investigators and/or supervisor. The CRCA will support federal and non-federal clinical research studies including epidemiological and investigative work in support of clinical trials, clinical research or biomedical research focusing on “bench to bedside” technology. The CRCA may need to provide own transportation with the ability to get to/from other off-site clinics. Occasional evening and weekend hours may be required.
- 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 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
- At least two (2) years of related work experience.
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.
- 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.
- Position may require being on-call and/or require weekend, evening, extended or unusual work hours based on research requirements and business needs.
- Position may require the employee to support studies that are conducted at off-site clinics (within a 50-mile radius of the main campus). Incumbent may need to provide own transportation with the ability to get to/from these off-site clinics.
- Schedule: Full-time
- Job Code: 4924
- Employee Status: Regular
- Grade: F
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 85984