The Division of Cardiovascular Medicine, in the 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 80 faculty, clinician educators and instructors who are the pillar of strength in the Division's ongoing efforts in the prevention and treatment of cardiovascular disease.
Under the supervision of the Clinical Research Manager and the Principal Investigator, the incumbent is responsible for coordinating clinical trials in the Interventional Cardiology Department. The incumbent is responsible for the timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments. This includes responsibility for the compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC). S/he will work with the clinical research team to manage and collect accurate data and assist Principal Investigators and study coordinators for all data management aspects of their clinical trials. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies.
As an Assistant Clinical Research Coordinator, you'll play a key role in supporting the management and coordination of clinical trials and research studies. Working closely with senior team members, you'll help organize tasks, meet deadlines, and ensure compliance with study protocols and regulations. This position offers hands-on experience in a dynamic research environment where your contributions will directly impact the success of clinical projects.
Duties include:
- Schedule and/or call subjects for appointments; contact participants with reminders or other requirements.
- Prepare, distribute, and process questionnaires.
- Perform clerical duties in the preparation of regulatory documents. Maintain all forms and documents, including consent forms and master subject logs. File all appropriate correspondence.
- 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.
- 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. Collect data and complete case report forms.
- Perform basic measurements and tests on patients according to protocol, such as obtaining vital signs and performing phlebotomy and EKG, after appropriate training/certification. Collect study specimens according to protocol.
- Prepare, process, and ship specimens/samples accurately under well-defined requirements.
- Order and maintain equipment and supplies.
- Process study compensation payments and thank you letters to subjects upon completion of trial activities. Assist with post-study activities, as needed.
DESIRED QUALIFICATIONS:
- Experience with clinical research. Knowledge with various types of human subject clinical trials i.e., Industrial, and Investigator-authored.
- Experience with clinical trial management systems, electronic data capture and OnCore.
EDUCATION & EXPERIENCE (REQUIRED):
- Two-year college degree and one year of relevant experience or an equivalent combination of experience, education, and training.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- General 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.
WORKING STANDARDS:
- 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.
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