{bc}
oracle

Project Manager I

University of South Florida
Tampa, USA
Full-time
Manager · 9+ years experience
Onsite
Discovered 1 weeks ago
gcp

Full Job Posting

Qualifications

  • This position requires a Bachelor’s degree in a related field and 2 years of project management or coordination experience; Some positions may require project management certification. Degree Equivalency Clause: Four years of direct experience for a bachelor’s degree. • Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is conditional upon meeting all employment eligibility requirements in the U.S. • SB 1310: Substitution of Work Experience for Postsecondary Education Requirements • A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: • (a) Two years of direct experience for an associate degree; • (b) Four years of direct experience for a bachelor’s degree; • (c) Six years of direct experience for a master’s degree; • (d) Seven years of direct experience for a professional degree; or • (e) Nine years of direct experience for a doctoral degree • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. • Minimum Qualifications that require a high school diploma are exempt from SB 1310. Preferred Qualifications:
  • Master's degree in Nursing, Public Health, Health Sciences, Exercise Science, Psychology, or a related health field.
  • Experience coordinating federally funded clinical, behavioral, or translational research studies.
  • Knowledge of human subjects research regulations, Good Clinical Practice (GCP), and Institutional Review Board processes.
  • Experience working with cardiovascular disease populations and women's health research.
  • Experience managing research studies from initiation through closeout.
  • Professional research certification (ACRP, SOCRA, or equivalent) preferred.
  • Experience using electronic health records, REDCap, and electronic data capture systems.
  • Demonstrated project management, organizational, leadership, and communication skills.
  • This position requires a Bachelor’s degree in a related field and 2 years of project management or coordination experience; Some positions may require project management certification.
  • Degree Equivalency Clause: Four years of direct experience for a bachelor’s degree.
  • Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is conditional upon meeting all employment eligibility requirements in the U.S.
  • SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
  • (a) Two years of direct experience for an associate degree;
  • (b) Four years of direct experience for a bachelor’s degree;
  • (c) Six years of direct experience for a master’s degree;
  • (d) Seven years of direct experience for a professional degree; or
  • (e) Nine years of direct experience for a doctoral degree
  • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
  • Minimum Qualifications that require a high school diploma are exempt from SB 1310.

Responsibilities

  • Study Management and Regulatory Oversight (40%)
  • Provides leadership and day-to-day operational management of a five-year federally funded clinical research study. Coordinates and monitors all study activities to ensure compliance with approved protocols, funding agency requirements, Good Clinical Practice standards, and institutional policies.
  • Plans, coordinates, and oversees participant recruitment, screening, enrollment, randomization, informed consent procedures, study visits, retention activities, and follow-up assessments.
  • Prepares, submits, and maintains regulatory documentation, including Institutional Review Board (IRB) applications, amendments, continuing reviews, adverse event reports, protocol deviations, and study correspondence. Serves as the primary contact for regulatory matters and ensures completion of all required regulatory reporting.
  • Monitors study progress and operational performance, identifies issues affecting study implementation, and develops corrective action plans to maintain compliance, participant safety, and study objectives.
  • Coordinates study meetings, tracks milestones and deliverables, and assists with budget monitoring and financial documentation to support effective study management.
  • Protocol Implementation, Data Management, and Quality Assurance (40%)
  • Directs implementation of study protocols and procedures across participating research sites to ensure standardization and consistency of study activities.
  • Coordinates procurement, inventory management, and distribution of study supplies, intervention materials, and equipment necessary for study implementation.
  • Oversees participant assessments, intervention delivery, and data collection activities. Ensures accurate, complete, and timely collection and management of research data in accordance with study protocols and federal requirements.
  • Maintains quality assurance and quality control procedures to safeguard data integrity and participant safety. Conducts ongoing review of study processes and recommends procedural improvements to enhance study efficiency and data quality.
  • Provides participant education and training regarding study procedures and the use of digital health technologies, including smartphone- and smartwatch-based applications utilized within the research protocol.
  • Prepares data safety monitoring reports and other required study documentation. Interprets and applies federal, state, institutional, and sponsor regulations governing human subjects research.
  • Coordinates study activities with investigators, research staff, and collaborating institutions to ensure successful implementation and achievement of study objectives.
  • Personnel Leadership and Supervision (15%)
  • Recruits, trains, supervises, and evaluates study personnel, including research nurses, health coaches, graduate student workers, research assistants, and study volunteers.
  • Develops and implements training programs to ensure consistent application of study protocols, participant safety procedures, regulatory requirements, and data collection methods across all study personnel and study sites.
  • Provides ongoing performance oversight and mentorship to study staff. Conducts quality assurance reviews and intervention fidelity assessments to ensure adherence to established protocols and standardized intervention delivery.
  • Coordinates activities among multiple study sites to ensure consistent implementation of research procedures and data collection practices.
  • Stakeholder Relations and Collaboration (4%)
  • Establishes and maintains effective working relationships with investigators, collaborating institutions, university departments, community partners, research participants, and federal funding agencies.
  • Serves as a liaison among research stakeholders to facilitate communication, coordination of activities, and successful completion of project objectives.
  • Administrative Support (1%)
  • Performs administrative duties in support of study operations, including document preparation, electronic record maintenance, filing, copying, scanning, and other routine office functions.
  • SUPERVISORY RESPONSIBILITIES
  • Directly supervises research personnel, including:
  • Research Nurse
  • Health Coach
  • Graduate Student Workers
  • Research Assistants
  • Study Volunteers
  • Responsibilities include hiring recommendations, onboarding, training, work assignment, performance monitoring, protocol oversight, and ongoing supervision of study-related activities

Preferred Qualifications

  • Master's degree in Nursing, Public Health, Health Sciences, Exercise Science, Psychology, or a related health field.
  • Experience coordinating federally funded clinical, behavioral, or translational research studies.
  • Knowledge of human subjects research regulations, Good Clinical Practice (GCP), and Institutional Review Board processes.
  • Experience working with cardiovascular disease populations and women's health research.
  • Experience managing research studies from initiation through closeout.
  • Professional research certification (ACRP, SOCRA, or equivalent) preferred.
  • Experience using electronic health records, REDCap, and electronic data capture systems.
  • Demonstrated project management, organizational, leadership, and communication skills.

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