The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations including the evaluation of new pharmacologic agents, which offer potentially promising therapeutic benefits, as well as outcome studies which characterize clinical parameters to effect positive changes in patient care.
The Division of PACCM is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor.
- 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.
- 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.
*- 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.
- Experience with database systems such as RedCap
- Ability to comprehend study design/ implement, administer and coordinate protocol activities during standard of care to Intensive Care Unit patients.
- Interest in learning about the care of critically ill medical and surgical patients in an intensive care setting.
- A willingness to learn basic laboratory skills needed to process biospecimens.
- Knowledge of handling lab specimens for shipping.
- Knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
- Strong interpersonal skills to communicate with patient’s surrogates in the context of the patient’s critical illness, as well as interact with treating physicians, nurses, pharmacy and other health care providers.
- Requires knowledge of Institutional Review Board (IRB) policy regarding consenting procedures and be able to maintain proper communication with IRB regarding Serious Adverse Event (SAE) reporting, protocol violations and amendment reviews and revisions.
- Requires ability to provide source documentation for all study entry, including laboratory, pharmacy and medical record retention.
- Requires good computer Skills (able to use Microsoft Word and Excel).
- Experience in all phases of industry-sponsored and NIH funded clinical trials.
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.
- 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.
- 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/ .
WHY STANFORD IS FOR YOU:
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:
- Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
- A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
- A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
- Discovery and fun. Stroll through historic sculptures, trails, and museums.
- Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
*- 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.
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