- 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 complex clinical drug trials with enrollment with neonates (recruitment goal of 6 patients). This includes consenting and interacting with study participants during study visits.
- Coordinate study visits with heart transplant research participants including conducting questionnaires and medical compliance forms (TEAMMATE Pediatric Heart Transplant Study, recruitment goal of 20).
- Monitor and approve weekly study invoices to ensure patients are not inappropriately charged.
- Create/Assist in creating study workflows for complex clinical trials that involve multiple visits.
- Coordinate collection of study specimens and processing.
- Screen eligible patients and review inclusion/exclusion criteria with principal investigator.
- 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.
- Strong oral and written communication skills
- Excellent attention to detail
- Proficiency in using computers, software, and web-based applications in a previous administrative setting
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
- 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.
- Schedule: Full-time
- Employee Status: Regular
- Grade: F
- Department
- Requisition ID: 103187
- Work Arrangement : Hybrid Eligible
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Clinical Research Coordinator Associate - Stanford, United States - Stanford University
Description
Stanford University Clinical and Translational Research Program in the Heart Center at Lucille Packard Children's Hospital 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 the principal investigator and/or study coordinator/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.
Duties include:
~ All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. ~
DESIRED QUALIFICATIONS:
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):
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
PHYSICAL REQUIREMENTS*:
WORKING CONDITIONS:
Occasional evening and weekend hours.
Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position.
The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.
The pay range for this position working in the California Bay area is $31.73-$36.54.Additional Information
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