Regulatory Research Project Coordinator, Part Time
Baylor Scott & White Health
Location: Dallas, Texas
Internal Number: 23017099
The Regulatory Research Project Coordinator is accountable for administrative regulatory tasks such as planning, developing, implementing, managing and reporting on multiple aspects of a multidisciplinary research program. This position will use project management skills and tools to develop and implement strategies that ensure timely advancement of a proposed research program to meet intended goals and priorities while complying with all institutional, federal and state rules, regulations and funding constraints.
ESSENTIAL FUNCTIONS OF THE ROLE
Works with team managers and others to define the strategic initiatives, scope, goals and timelines of the research program.
Develops program budgets and ensures that budget requirements are met, including review of program-related contracts and approval of invoices within the program budget.
Prepares helping documents, including the clinical protocol, investigator's brochure, case report forms, informed consent documents and components of an IND application.
Serves as the program's liaison with internal and external departments and personnel involved in, or contributing to, the program to resolve barriers to the advancement of the program's strategic initiatives. Uses project management skills to ensure that the program progresses according to established timelines.
Fosters relationships with external entities, including academia, pharmaceutical and biotechnology industries; maintains current relationships and establishes new relationships with entities that can contribute to the goals of the program.
Designs and implements processes and procedures to ensure advancement of the program's strategic initiatives.
Provides guidance to program team members and interacts regularly with the program team to establish resource needs, coordinate activities of operational areas and identify deliverables and target due dates.
Organizes and conducts team meetings to ensure adherence to strategic initiatives, goals, budget and timelines.
KEY SUCCESS FACTORS
Proven written and oral communication skills.
Regulatory experience such as reviewing, filling, and assisting to meet deadlines.
Exceptional computer skills, including Microsoft office, Excel and PowerPoint.
Ability to manage time reactive projects in order to meet deadlines.
Exceptional ability to establish and maintain effective working relationships.
LOCATION: Soltero Cardiovascular Research Center, Dallas
SCHEDULE: Part time, Day Shift
Our competitive benefits package includes the following.
Immediate eligibility for health and welfare benefits
401(k) savings plan with dollar-for-dollar match up to 5%
PTO accrual beginning Day 1
Note: Benefits may vary based upon position type and/or level
EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
Baylor Scott & White Health (BSWH) is the largest not-for-profit health care system in Texas and one of the largest in the United States. With a commitment to and a track record of innovation, collaboration, integrity and compassion for the patient, BSWH stands to be one of the nation’s exemplary health care organizations. Our mission is to serve all people by providing personalized health and wellness through exemplary care, education and research as a Christian ministry of healing. Joining our team is not just accepting a job, it’s accepting a calling!