Clinical Research Regulatory Specialist

2 weeks ago

Dallas, Texas, United States Baylor Scott & White Health Full time
Shift: 8AM-5PM

Location:
Sammons Cancer Center

3410 Worth St, Dallas, 75246

Dept:
Oncology

JOB SUMMARY


The Clinical Research Regulatory Specialist helps clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure.

The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external and federal policies and regulations pertinent to research involving human subjects.

This position also provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures and regulations.


ESSENTIAL FUNCTIONS OF THE ROLE

  • Prepares, facilitates and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
  • Ensures that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB. Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions.
  • Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research. Obtains Sponsor approval of consent form prior to submission to the IRB.
  • Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by partnering with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents. Ensures that regulatory binders are audited and maintained.
  • Tracks workload and status of pending protocols and associated upholding documents in order to provide efficient customer service to the Research team.
  • Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed. Oversees QA initiatives for the department to help research staff and managers during sponsor and FDA audits.
  • Facilitates investigator-initiated research by ensuring all regulatory requirements are met, to include ensuring requirements for trial registration, results and reporting are completed in a timely manner consistent with federal regulations.

KEY SUCCESS FACTORS

  • Proven written and oral communication skills.
  • Proven leadership skills in project management, including project management tools and techniques.
  • Exceptional computer skills, including Microsoft Office, Excel and PowerPoint.
  • Ability to manage time reactive projects in order to meet deadlines.
  • Excellent ability to establish and maintain effective working relationships.

BENEFITS
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%
  • Tuition Reimbursement
  • PTO accrual beginning Day 1

Note:
Benefits may vary based upon position type and/or level

SQUALIFICATIONS

  • EDUCATION - Associate's or 2 years of work experience above the minimum qualification
  • EXPERIENCE - 3 Years of Experience

  • Clinical Research Assistant

    1 week ago

    Dallas, Texas, United States Velocity Clinical Research, Inc. Full time

    Overview:Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites.At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We...

  • Regulatory Associate, Office of Research Support and Regulatory Management

    2 weeks ago

    Dallas, Texas, United States The University of Texas Southwestern Medical Center Full time

    UT Southwestern Medical Center is hiring for Regulatory Associate, Office of Research Support & Regulatory Management The Regulatory Associate will be responsible for processing UTSW employee requests to engage in outside activities and employment, e Regulatory, Research, Associate, Support, Office, Management, Healthcare, Technology

  • Research RN, Office of Clinical Research

    1 month ago

    Dallas, Texas, United States University of Texas Southwestern Medical Center Full time

    Why UT Southwestern?With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. At UT Southwestern, we invest in you with opportunities for career growth and development that align with your future goals and help to provide security for you and your family. Our highly...

  • Research RN, Office of Clinical Research

    4 weeks ago

    Dallas, Texas, United States University of Texas Southwestern Medical Center Full time

    Why UT Southwestern?With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. At UT Southwestern, we invest in you with opportunities for career growth and development that align with your future goals and help to provide security for you and your family. Our highly...

  • Regulatory Associate, Simmons Cancer Center

    2 weeks ago

    Dallas, Texas, United States UT Southwestern Medical Center Full time

    Regulatory Associate, Simmons Comprehensive Cancer Center - Cancer ResearchWhy UT Southwestern?With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for...

  • Submission for the position: Clinical Research Coordinator

    1 week ago

    Dallas, Texas, United States Baylor Scott & White Healthcare Full time

    We are currently seeking a Clinical Research Coordinator 1 to join our team at Baylor University Medical Center.Assist Principal Investigators in conducting clinical trials from pre-study implementation to study closure.Collaborate with various departments to implement research protocols.Ensure compliance with federal, state, and institutional...

  • Submission for the position: Clinical Research Coordinator

    2 weeks ago

    Dallas, Texas, United States Baylor Scott & White Healthcare Full time

    JOB SUMMARYThe Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation through study closure per federal, state and Institutional guidelines. This position will learn to assist Principal Investigators on more complex...

  • Clinical Research Coordinator I, Behavioral Neurology

    2 weeks ago

    Dallas, Texas, United States UT Southwestern Medical Center Full time

    Why UT Southwestern? UT Southwestern Medical Center is one of the 10 best large employers in the United States and among the top 5 of healthcare employers, according to the America's Best Employers 2022 list compiled by Forbes. UTSW is also ranked as the top healthcare employer for diversity in the US according to the America's Best Employers for Diversity...

  • Clinical Research Coordinator I

    1 week ago

    Dallas, Texas, United States US Oncology, Inc. Full time

    OverviewTexas Oncology is looking for a full-time Clinical Research Coordinator to join our teamThis position will support the Dallas Presbyterian location . Texas Oncology is the largest community oncology provider in the country and has approximately 600+ providers in 220+ sites across Texas and southeastern Oklahoma. Our founders pioneered community-based...

  • Clinical Epidemiologist Research

    1 month ago

    Dallas, Texas, United States Parkland Health and Hospital System Full time

    Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a...

  • Clinical Epidemiologist Research

    4 weeks ago

    Dallas, Texas, United States Parkland Health and Hospital System Full time

    Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a...

  • Clinical Research Coordinator

    1 week ago

    Dallas, Texas, United States Allergy Partners Full time

    Job DetailsJob Location70-00-Dallas - Dallas, TXDescriptionJOB SUMMARY:clinical coordination of all aspects of adult and/or pediatric clinical research trials primarily sponsored by pharmaceutical companies.Responsibilities include, but are not limited to, the following:Clinical SupportPerforms all aspects of research related job duties in accordance with...

  • Clinical Pharmacy Specialist

    3 weeks ago

    Dallas, Texas, United States Parkland Health and Hospital System Full time

    Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a...

  • Research RN, Neonatal ICU- Pediatrics

    1 week ago

    Dallas, Texas, United States University of Texas Southwestern Medical Center Full time

    Join UT Southwestern as a Research RN in Neonatal ICU-PediatricsLooking for a rewarding opportunity in Dallas-Fort Worth, Texas? UT Southwestern has been a leader in excellence for over 75 years, prioritizing innovation, teamwork, and compassion.At UT Southwestern, we invest in your career growth, future goals, and family security. Our competitive benefits...

  • Research Grant Specialist

    1 week ago

    Dallas, Texas, United States Parkland Health & Hospital System Full time

    Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a...

  • Chief Research Officer

    1 month ago

    Dallas, Texas, United States Parkland Health and Hospital System Full time

    Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a...

  • Research Enrollment Analyst

    4 weeks ago

    Dallas, Texas, United States Baylor Scott & White Health Full time

    Shift: 8AM -5PMLocation: 3409 Worth Street Dallas, TX 75246JOB SUMMARYThe Research Enrollment Analyst, under general supervision, is accountable for enrolling participants in research projects, and developing and working on a self-directed research project that furthers the goals of the Investigators and Research Department.ESSENTIAL FUNCTIONS OF THE...

  • Research Enrollment Analyst

    1 month ago

    Dallas, Texas, United States Baylor Scott & White Health Full time

    Shift: 8AM -5PMLocation: 3409 Worth Street Dallas, TX 75246JOB SUMMARYThe Research Enrollment Analyst, under general supervision, is accountable for enrolling participants in research projects, and developing and working on a self-directed research project that furthers the goals of the Investigators and Research Department.ESSENTIAL FUNCTIONS OF THE...

  • Research Enrollment Analyst

    1 week ago

    Dallas, Texas, United States Baylor Scott White Health Full time

    JOB DESCRIPTION Shift: 8AM -5PM Location: 3500 Gaston Ave JOB SUMMARY The Research Enrollment Analyst, under general supervision, is accountable for enrolling participants in research projects, and developing and working on a self-directed research project that furthers the goals of the Investigators and Research Department. ESSENTIAL FUNCTIONS...

  • Clinical Applications Specialist

    2 weeks ago

    Dallas, Texas, United States GE HealthCare Technologies, Inc. Full time

    Sales support to include both remote and onsite product demonstrations, direct Sales Specialist assistance, and direct customer assistance. Use market and product knowledge to assist sales team in developing sales, marketing, and customer service str Applications Specialist, Ultrasound, Clinical, Solutions, Sales Specialist, Application, Technology