2024-05-12
University of Pittsburgh
Other
/yr
employee
contract
Pittsburgh
Pennsylvania
15260
United States
Post Doctoral.Post Doctoral.Associate
Med-Medicine - Pennsylvania-Pittsburgh - (24003744)
The Department of Medicine, Division of Rheumatology and Clinical Immunology is seeking a post-doctoral associate with an MD or equivalent degree through the t-CRiSP Program. The candidate will serve as a medically trained professional working with and under the direction of Mentor and Principal Investigator, Rohit Aggarwal. The Post-Doctoral Associate will be working on the Myositis Clinical trial and studies (Myositis Interstitial Lung Disease (MINT) clinical trial, Clinical Meaningfulness of Total Improvement Score of ACR/EULAR Myositis Response Criteria and Myositis Outcomes and Disease Burden Assessment, account # 05.35457.5201.00000.717413.00000.00000. The MINT study is a decentralized major double-blind randomized controlled clinical trial on patients with myositis-associated ILD, where patients from anywhere in the USA can be enrolled remotely and followed in a decentralized manner.
The t-CRiSP PDA will work with the PI on design, conduct, and management of the clinical trial. They will support, facilitate, and coordinate the clinical trial activities for the PI and study team and will play a critical role in the conduct of the study from study start-up to closure (time permitted). The t-CRiSP PDA will work with the PI, department, sponsor, and institution to support and provide guidance on the study aims, regulations, safety, compliance, and other scientific and operational aspects of the clinical study Utilizing Good Clinical Practice, the CRS ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) and study sponsor.
• Supports PI to design protocol and prepare for study operations.
• Along with the PI, will be a site expert in the study protocol, study procedures, timelines, inclusion and exclusion criteria, confidentiality, data and specimen, and privacy protections.
• Designs and prepares study materials and data collection tools in collaboration with the PI and statistical center. This will include but not be limited to; protocol for regulatory review, informed consent documents, case report forms (CRFs), source documents, study logs, drug/device accountability documents, study surveys/questionnaires, etc.
• Prepares and manages study budget, accountability, and invoicing.
• Created and lead training for study teams and faculty
• Maintains regulatory and essential documents in accordance with federal regulations.
• Provides accurate and timely data collection, reporting, and analysis. Support data analysis as requested.
• Track research subjects and coordinate subject assessments, procedures, treatment, and follow-up at appropriate time intervals in compliance with the study protocol.
• Prepare site and study documents for monitoring and audit visits.
• Preparation and contribution to data analysis, presentations, manuscripts, and related grants
• Other tasks assigned by the mentor.
Core Skills required
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
PI240740399
