The Clinical Research Manager for the Hypertrophic Cardiomyopathy (HCM) and Amyloid Clinical Research Program oversees and manages the day to day operations of clinical research activities conducted within the trials program within Knight Cardiovascular Institute. This position provides direct management for all research coordinators within the HCM/Amyloid Trials Program. This includes performance management, recruitment, orientation and onboarding of new staff, as well as ensuring that staff are reporting their time accurately and timely for internal billing to the studies.
This position is also responsible for day to day operational management of all active trials within the program, this includes management and coordination of all study startup activities, working with the Education/Regulatory Specialist in the program to ensure regulatory requirements are being met, including development of preparatory workflows for potential FDA audit, as tracking enrollment and screening data to ensure enrollment goals are met for each of the studies. Lastly this position is also responsible for working with the Trials Administrator in developing study budgets, reporting accurate and timely coordinator hours for internal billing processes, and providing required information to the Trials Administrator and finance team for the development of the fiscal year budget for the trials program.
The Clinical Research Manager will also be responsible for working with the Trials Administrator in developing standard processes for the facilitation of clinical trials within the Institute. This requires interfacing with central service teams at OHSU to ensure alignment of procedures with institutional standards.
Direct supervision of entry level through senior level clinical research staff including performance management, disciplinary action, coaching, team building, delegation of tasks as well as defining specific roles and responsibilities within the team.
Promote retention and engagement by building a foundation in clinical research fundamentals while building strong clinical research coordination support for the KCVI clinical research program.
Day to day operational issues, and cross-training for back-up coverage in all areas of clinical trials operations - regulatory/IRB, patient assessments and care, sponsor communications, data entry and query resolution.
Responsible for the recruitment and hiring of all clinical research staff for the Interventional Clinical Research Team.
Collaborate with HR and the Education /Regulatory Specialist in building a standardized onboarding plan for new staff.
Coordinate site qualification visits, execution of startup documentation, oversight of data entry and management of information in OHSU’s central CTMS system, timely and accurate submission of case report forms to the sponsor, as well as overseeing enrollment and patient screening to ensure enrollment goals are met.
Responsible for ensuring the Research Coordinators are completing required regulatory work for each study. This includes maintaining all active IRB protocols, including amendments, termination of protocols, and startup of new protocol.
Ensure required documentation is filed and provided to the sponsors in accordance with FDA requirements, and working with program leadership to prepare and participate in FDA audits as they occur.
Responsible for working with the Trials Administrator and investigators to develop new study budgets, working with the finance team to ensure coordinator time is billed timely and accurately through internal billing processes, and assist the Trials Administrator in development of fiscal year budgets for the Interventional program.
Collaborate with the Trials Administrator in the development of standard workflows and SOP’s to ensure compliance, efficiency and consistency in support for trials within the program.
Bachelor’s Degree in health care related field or equivalent plus 4 years in research/program management including direct personnel management
Experience in developing clinical trials budgets
Experience in managing regulatory components related to clinical studies
Experience navigating a Clinical Trials Management Systems (CTMS)
Experience navigating electronic health records
Master's in relevant field AND 3 years of relevant experience in coordinating clinical trials OR Equivalent combination of Bachelor's in relevant field in conjunction with training and experience may be considered.
4 years’ experience in Clinical Research Program Management including direct personnel management
Extensive experience in developing clinical trials budgets
Extensive experience in managing regulatory components related to clinical studies
Extensive experience navigating a Clinical Trials Management Systems (CTMS)
Experience in managing drug-related clinical studies
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