Clinical Research Coordinator Associate
School of Medicine, Stanford, California, United States
The Division of Nephrology
, within the Stanford Department of Medicine, is seeking a full-time Clinical Research Coordinator Associate to join our team and help make a difference for persons with kidney disease! These studies involve persons with kidney disease, either those with a kidney transplant or those receiving hemodialysis for kidney failure. As kidney disease disproportionally affects persons from underserved populations, this is an opportunity to do research that advances the health and well-being of those communities. The CRCA will work directly with two principal investigators doing research on 1) kidney transplantation and 2) hemodialysis treatment for kidney failure. For research focusing on transplantation, the CRCA will coordinate a multiple-site study involving subjects from 5 different centers throughout the country. For research focusing on hemodialysis, the CRCA will be coordinating a single site study recruiting participants in the Bay area.
The CRCA will perform support duties related to the collection of clinical data and/or the coordination of clinical studies, and will work under supervision of the principal investigator and/or study coordinator/supervisor.Duties include:
Additional duties include:
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from star-up through closeout.
- Reaching out to potential participants either in person, via phone or via email to gauge interest.
- Schedule and/or call subjects for appointments; contact participants with reminders or other requirements.
- Perform duties in the preparation of clinical trial documents. Print, save and file sponsor emails. Update, and maintain all regulatory and IRB forms and documents, obtain hospital calibration records, prepare regulatory documents and master subject source documents. File all items in either source or regulatory binders
- Assist with the screening, recruiting, and obtaining consent of study participants. Review medical records and/or perform telephone or in-person interviews to gather data, as needed. Send out study results as needed and answer sponsor lab and result queries. Schedule follow-up labs as needed and enter results in sponsor systems.
- Administer standard study questionnaires and tests, score test measurements and questionnaires, and code data for computer entry. Perform quantitative review of forms, tests, and other measurements for completeness and accuracy.
- Extract data from source documents for research studies as directed and then enter data into case report forms.
- Prepare, process, and ship specimens/samples accurately under well-defined requirements
- Order and maintain adequate supply of study supplies, kits, equipment and shipping supplies.
- Participate in monitor visits and regulatory audits.
*- The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS:
- 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.
EDUCATION & EXPERIENCE (REQUIRED):
- 1-3 years of clinical research coordinator experience.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
KNOWLEDGE, SKILLS AND ABILITIES (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.
CERTIFICATIONS & LICENSES:
- 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.
*- 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.WORKING STANDARDS:
- 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.
Why Stanford is for You
- 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 other policies found in the University's Administrative Guide, http://adminguide.stanford.edu/.
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks
empower you with:
*- Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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