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The Project Manager, Research Support coordinates and leads efforts in a variety of research activities that are complex and wide in scope. Moreover, the Project Manager, Research Support operates with the goal of ensuring that the collection of data and administration of studies are performed efficiently and in compliance with applicable guidelines.
- Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Prepare and oversee the development of study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Participate in the development of study protocols including guidelines for administration or data collection procedures.
- Oversee subject enrollment to ensure that project timelines are being met.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts. Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Participate in preparation and management of research budgets and monetary disbursements and track items related to the status of agreements, budgets, and contracts.
- Assist in preparing clinical study reports and annual safety reports.
- Review monitoring reports for accuracy, completeness and conformance with standard operating procedures (SOPs).
- Maintain frequent contact with and work effectively with investigators and coordinators.
- Provide guidance, clinical trial management expertise, and direction to contract clinical research associates (CRAs) in the field and in-house staff.
- May monitor/audit clinical sites for adherence to protocol and good clinical practice (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 investigational sites with company SOPs, EMA/FDA, and ICH guidelines.
- Review and/or submission of research ethics committee/regulatory documentation.
- Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
- Develop and maintain good working relationships with investigators and study staff.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures. Assist with establishing and tracking clinical timelines and appropriate performance metrics.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience).
- Investigate queries, monitor discrepancies as applicable.
- Manage/oversee investigational product (IP) accountability and reconciliation process.
- Responsible for review or approval of IP release packages in collaboration with monitoring project team members.
Bachelor's degree in relevant field requiredExperience:
Minimum 3 years of relevant experienceKnowledge, Skills and Attitudes:
- Skill in collecting, organizing, and analyzing data.
- Ability to recognize, analyze, and solve a variety of problems.
- Ability to exercise sound judgment in making critical decisions.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:
Full timeEmployee Type: