Clinical Research Coordinator A/B (Pulmonary, Allergy and Critical Care)
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Posted Job Title
Clinical Research Coordinator A/B (Pulmonary, Allergy and Critical Care)
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
The clinical research coordinator will assist in the coordination of Phase I-IV clinical trials and registries for the Pulmonary Vascular Disease Program.
Job Description
The Clinical Research Coordinator A will assist in the coordination of Phase I-IV clinical trials and registries for the Pulmonary Vascular Disease Program. Screen, recruit, consent and enroll eligible subjects per protocol using GCP guidelines. Implement various research protocols and guidelines. Provide education to the patient and/or families. Responsible for management and oversight of research medication administration, monitoring of patient care, monitoring of side effects/adverse events, and maintaining general oversight of patient status throughout study period. Will record and report adverse events and serious adverse events per protocols. Manage patient treatment per protocol, schedule clinical and research office visits, interact with cardiology and pulmonary staff to schedule and oversee research testing. Responsible for drawing labs (phlebotomy training preferred), sample processing and shipping. Responsible for performing vital signs and EKGs for study visits. Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Responsible for accurate data collection and data entry. Responsible for the preparation and processing of all Institutional Review Board (IRB) documentation through the IRB and defined regulatory authorities, including submissions, continuing reviews, amendments, deviation and adverse event reporting. Work closely with study sponsors and physicians. Communicate any research issues to PI and primary MD, communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings and ongoing protocol training/compliance meetings. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Other duties as assigned.
With minimal supervision, the Clinical Research Coordinator B will coordinate Phase I-IV clinical trials and registries for the Pulmonary Vascular Disease Program. Screen, recruit, consent and enroll eligible subjects per protocol using GCP guidelines. Implement various research protocols and guidelines. Provide education to the patient and/or families. Responsible for management and oversight of research medication administration, monitoring of patient care, monitoring of side effects/adverse events, and maintaining general oversight of patient status throughout study period. Will record and report adverse events and serious adverse events per protocols. Manage patient treatment per protocol, schedule clinical and research office visits, interact with cardiology and pulmonary staff to schedule and oversee research testing. Responsible for drawing labs (phlebotomy training preferred), sample processing and shipping. Responsible for performing vital signs and EKGs for study visits. Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Responsible for accurate data collection and data entry. Responsible for the preparation and processing of all Institutional Review Board (IRB) documentation through the IRB and defined regulatory authorities, including submissions, continuing reviews, amendments, deviation and adverse event reporting. Work closely with study sponsors and physicians. Communicate any research issues to PI and primary MD, communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings and ongoing protocol training/compliance meetings. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. May act as a mentor to coordinators who have joined the program with less research experience.
***Position contingent upon funding***
Qualifications
CRC-A
Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. Phlebotomy experience preferred. Effective communication and writing skills; ability to multi-task and problem solve; Energetic, interactive and demonstrated ability to work as part of a team as well as independently; knowledge of IRB and human research protection regulations. Must possess strong computer skills and be able to independently and proficiently work in MS office suite. Position contingent upon funding.
CRC-B
Bachelor's degree and 2-4 years of related experience or equivalent combination of education and experience required. Phlebotomy expertise preferred. Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.
Working Conditions
Office, Library, Computer Room; Requires extensive safety
Physical Effort
Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$36,401.00 - $55,814.33
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
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