Manager, Clinical Research
University of Miami


Job Info


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Transforming Lives

The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.

With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.

The Office of the Vice Provost for Research & Scholarship, Clinical Trials Research Office (CTRO) has an exciting and immediate opportunity for a Manager, Clinical Research at the Coral Gables Campus.

CORE JOB SUMMARY

The Manager, Clinical Research oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies; and coordinates work with Study Managers and other relevant team members to assure the fidelity of study protocols and data collection.

CORE JOB FUNCTIONS


  • Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation.

  • Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests.

  • Assembles project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.

  • Manages investigator relationships.

  • Maintains IND and IDE documentation, including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA.

  • Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets.

  • Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies.

  • Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions.

  • Interacts with project team members to define submission logistics and workflow scheduling.

  • Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system.

  • Prepares and presents the annual summary report for clinical trial and research areas.

  • Provides consultation and guidance for UM held INDs and IDEs.

  • Develops, implements, maintains and oversees internal policies and SOPs as well as University-wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices.

  • Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.

  • Ensures employees are trained on controls within the function and on University policy and procedures.


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.

CORE QUALIFICATIONS

Education:

Master's degree in Science, Health care, or related field required.

Certification and Licensing:

Professional certification in at least one of the following areas: clinical research, research compliance, auditing, Good Clinical Practice (GCP) related field, etc., highly preferred.

Experience:

Minimum 5 years of effective work-related research experience including research compliance/quality assurance and management experience as a department or division director, project leader, or similar role required. Any appropriate combination of relevant education and/or work experience may be considered.

Knowledge, Skills and Attitudes:

  • Expert knowledge of FDA, HHS, NIH, OHRP, etc., regulations and research related guidance documents.

  • Ability to communicate effectively in both oral and written form.

  • Ability to maintain effective interpersonal relationships.

  • Ability to process and handle confidential information with discretion.

  • Skill in completing assignments accurately and with attention to detail.

  • Proficiency in computer software (i.e. Microsoft Office); Information Technology (IT) knowledge.

  • Ability to communicate effectively in both oral and written form.

  • Ability to maintain effective interpersonal relationships.

  • Knowledge of business and management principles.

  • Ability to direct, manage, implement, and evaluate department operations.

  • Ability to establish department goals, and objectives that support the strategic plan.

  • Ability to effectively plan, delegate and/or supervise the work of others.

  • Ability to lead, motivate, develop, and train others.


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:
r9



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