Clinical Research Project Manager – Hybrid/Remote

University of Miami


Current Employees:

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet .

The Office of the Vice Provost for Research & Scholarship, Clinical Research Management & Support Office (CRMSO) has an exciting job opportunity for a Clinical Research Project Manager to work at the University of Miami.

CORE JOB SUMMARY                                                                                           

The Clinical Research Project Manager 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 will promote 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                                             

  • Prepares for or participates in quality 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 subject risks.
  • 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 investigational sites 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.
  • Manages and oversees investigational product (IP) accountability and reconciliation process.
  • Responsible for review or approval of IP release packages in collaboration with monitoring project team members.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

QUALIFICATIONS

Education:

Bachelor degree; Masters preferred or equivalent combination of education, training, and experience.

Experience:

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.
  • Proficient in computer software (i.e., Microsoft Office).
  • Advanced knowledge about Project Management Concepts.

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 time

Employee Type:

Staff

Pay Grade:

c107

To help us track our recruitment effort, please indicate in your cover/motivation letter where (jobs-near-me.eu) you saw this job posting.