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||Medley, FL United States
|| Customer Service and Call Center
Clinical Research Project Manager|
The Office of the Vice Provost for Research & Scholarship, Clinical Research Management & Support Office (CRMSO) has an exciting job opportunity for a Clinical Research Manager at the Medical Campus.
/> The Manager, Clinical Research oversees the planning and management of clinical trials and research projects that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies; and coordinates central resource services for principal investigators and other relevant team members.
Additionally, an employee at this level, as a Research Professional Associate, (RPA II) promotes clinical research by providing quality services related to research reviews, advanced QA and QA assessments, research program management and educational functions, by applying a solution-based, collaborative approach with the goal of continuous quality improvement.
Core Job Functions:
Analyzes research programs and proactively identifies trends.
Conducts audits of research protocols.
Assists in investigations as directed.
res and creates audit and investigation.
Conducts reviews of protocol and other submissions and communicates with researchers as it relates to regulatory deficiencies.
Assists with Research Program management.
Creates and presents research-related educational materials within and outside the University of Miami.
Prepares documents for submission to federal agencies.
Keeps abreast of current federal regulations and guidance documents, State laws, University of Miami policies and procedures as well as departmental SOPs and informs OVPRS leadership of changes.
Promotes quality improvement and best practice solutions.
Communicates with the research community, all OVPRS groups and external customers as applicable and provides consistent excellent customer service.
Department Specific Functions:
Prepares for or participates in
lity assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
Prepares and oversee the development of study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Participates in the development of study protocols including guidelines for administration or data collection procedures.
Oversees subject enrollment to ensure that project timelines are being met.
Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential sub
Participates in preparation and management of research budgets and monetary disbursements and tracks items related to CDAs, budget and contract completion status.
Assists in preparing Clinical Study Reports and annual safety reports.
Reviews monitoring reports for accuracy, completeness, and conformance with SOPs.
Maintains frequent contact with and works effectively and collaboratively with investigators and study team members, as well as other departments and groups.
Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff.
May monitor/audit clinical sites for adherence to protocol and GCP, including conducting site pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits conducted by monitoring personnel.
Assurance of regulatory compliance of investigati
es with company SOPs, EMA/FDA and ICH-GCP guidelines.
Reviews and/or submission of research ethics committee/regulatory documentation.
Identifies, selects, and monitors performance of investigational sites for clinical studies; prepares accurate and timely visit reports from all site interactions and visits.
Develops and maintains good working relationships with investigators and study staff.
Ensures studies are carried out according to the study protocol, SOPs, and ICH-GCP, federal regulations and study-specific manuals and procedures.
Assists with establishing and tracking critical timelines and appropriate performance metrics.
Reviews key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determines appropriate action in conjunction with study team.
Investigates queries and monitors discrepancies as applicable.
ges and ov
ersees investigational product (IP) accountability and reconciliation process.
Responsible for review or approval of IP release packages in collaboration with monitoring project team members.
Masterís degree in relevant field required.
Minimum 5 years of relevant experience. Any appropriate or equivalent combination of education, training, and experience and/or certification may be considered.
Knowledge, Skills and Attitudes:
Advanced knowledge of research related federal regulations, guidance documents and State laws.
Must be able and willing to provide excellent customer service at all times.
Must be able to communicate effectively and customer-service oriented verbally and in writing.
Ability and willingness to continuous quality improvement and learning.
nt in computer software (i.e. Microsoft Office).
Advanced knowledge about Project Management Concepts.
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