ICU Research Coordinator
Stanford University, Department of Medicine is seeking an ICU Research Coordinator (Clinical Research Coordinator Associate) to perform duties related to the coordination of clinical studies in the Pulmonary & Critical Care Medicine Division. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor.
Duties include: 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. Patient screening will require thorough review and interpretation of patient's charts and medical history. This will require advanced medical knowledge to adjudicate subtle inclusion and exclusion criteria (i.e distinguishing hydrostatic pulmonary edema from acute lung injury, recognizing sepsis criteria, identifying comorbidities, etc.). The coordinator will have to independently adjudicate subtle inclusion and exclusion criteria as well as expected vs. unanticipated adverse events potentially related to study participation. Final adjudications will be made in consultation with the principal investigators but the coordinator will need to be able to function independently for the majority of the roles related to the study protocol.
Assist in developing recruitment strategies
Coordinate collection of study specimens and processing. Requires a willingness to learn basic laboratory skills needed to processes biospecimens. Training for this is available, though laboratory bench experience is a plus
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. Interact regularly with patients and their families, RN and RT team for biospecimens and timing of consent, PI's and fellow research coordinators.
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
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.
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 processes 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.
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.
Occasional evening and weekend hours. Flexibility in evening hours when a new patient enrolled is a plus.
Location: School of Medicine
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.