Jobs
>
Houston

    Senior Regulatory Affairs Associate - Houston, United States - Baylor College of Medicine

    Baylor College of Medicine
    Baylor College of Medicine Houston, United States

    Found in: beBee S2 US - 2 weeks ago

    Default job background
    Description


    Summary

    This role will primarily be responsible for the overall implementation and management of clinical studies that are regulated under the European Union General Data Protection Regulation or GDPR, and specifically, how GDPR information must be provided to research subjects, including privacy notices and consent forms, as well as managing studies under the Clinical Trials Support Office. This role provides support to address questions of the EU GDPR (European Union General Data Protection Regulation) regarding human subjects' research in clinical studies and how the enrollment of certain individuals/research subjects is documented, in addition to the US Common Rule CFR 46 Subpart A, and Informed Consent documentation.

    This role is eligible for a hybrid work schedule.

    Job Duties

    • Manages all components of the BCM GDPR program.
    • Develops and reports on performance metrics for the program.
    • Develops, reviews, and maintains the program's policies and procedures.
    • Develops, reviews, and maintains templates, tools, and guidance documents needed for the program's function.
    • Creates and delivers relevant workshops, presentations, and other educational materials and opportunities; leverages external training to benefit the program and research activities; effectively communicates the program's objectives to appropriate stakeholders.
    • Maintains the program's website.
    • Participates in long-range planning of the program's activities.
    • Maintains current knowledge of the regulatory environment, especially regulations changes and guidance documents applicable to European Union research.
    • Assists monitoring team and provides a review of ongoing monitoring reports as needed.
    • Assists with internal and external audits; prepares corrective actions, if necessary.
    • Provides regulatory administrative and clerical support.

    Minimum Qualifications

    • Bachelor's degree.
    • Four years of relevant experience.

    Preferred Qualifications

    • Certification as a Certified Clinical Research Professional (CCRP), or Clinical Research Associate (CRA)
    • Experience in regulatory writing and regulatory submission work
    • Knowledge of clinical research practices and principles
    • Well-versed in human subjects' research requirements and guidance according to the applicable Code of Federal Regulations (21 CFR parts 50, 54, 312, and 812), the provisions of the HHS Common Rule (46 CFR 45), and ICH GCP (E6) guidelines
    • Ability to work independently and drive processes
    • Ability to manage projects
    • Ability to work in a team and demonstrated interpersonal skills
    • Must have and exhibit computer skills and possess exemplary writing and verbal skills
    • Must have and exhibit attention to detail and excellent organizational skills
    • Must have excellent time management skills, including the ability to manage multiple and competing priorities
    • Excellent customer service skills, including the ability to interact effectively with diverse stakeholders, including faculty and research staff

    Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

    Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

    17630

    CH; SN


    View or Apply

    To help us track our recruitment effort, please indicate in your email – cover/motivation letter where ) you saw this job posting.

  • Healgen Scientific Limited

    Clinical Affairs Associate

    Found in: ZipRecruiter Test10P US C2 - 11 hours ago

    Healgen Scientific Limited Houston, United States

    Job Description · Job Description · We are seeking a highly motivated and detail-oriented Clinical Affairs Associate to join our dynamic team. The successful candidate will play a crucial role in supporting clinical affairs activities, ensuring compliance with regulatory requirem ...

  • Knewin

    Government Affairs Director

    Found in: Lensa US 4 C2 - 1 day ago

    Knewin Houston, United States

    Overview Pattern Energy is a leading renewable energy companythat develops, constructs, owns, and operates high-quality wind and solar generation, transmission, and energy storage facilities. Our mission is to transition the world to renewable energy through the sustainable devel ...

  • Pattern Energy Group

    Government Affairs Director

    Found in: Lensa US 4 C2 - 1 day ago

    Pattern Energy Group Houston, United States

    Overview: · Pattern Energy is a leading renewable energy company that develops, constructs, owns, and operates high-quality wind and solar generation, transmission, and energy storage facilities. Our mission is to transition the world to renewable energy through the sustainable ...

  • Knewin

    Government Affairs Director

    Found in: Lensa US 4 C2 - 14 hours ago

    Knewin Houston, United States

    Overview Pattern Energy is a leading renewable energy companythat develops, constructs, owns, and operates high-quality wind and solar generation, transmission, and energy storage facilities. Our mission is to transition the world to renewable energy through the sustainable devel ...

  • American Bureau of Shipping

    Regulatory Affairs Manager

    Found in: Lensa US 4 C2 - 14 hours ago

    American Bureau of Shipping Houston, United States

    The Regulatory Affairs Manager promotes the consistent and proper application of international marine regulations, fulfilling International Association of Classification Societies (IACS) obligations and effectively liaising with regulatory agencies. The Regulatory Affairs Manager ...

  • LADGOV CORPORATION

    Clinical Coordination Support

    Found in: Lensa US 4 C2 - 2 days ago

    LADGOV CORPORATION Houston, United States

    Job Title: CLINICAL COORDINATION SUPPORTLocation: JBSA Ft Sam Houston , TX 78234Duties: Serve as a clinical liaison to communicate information and feedback between METC programs, Program Clinical Coordinators, METC Clinical Coordinator, Dean of Academic Affairs, Associate Dean of ...

  • LADGOV CORPORATION

    Clinical Coordination Support

    Found in: Lensa US 4 C2 - 1 day ago

    LADGOV CORPORATION Houston, United States

    Job Title: CLINICAL COORDINATION SUPPORT · Location: JBSA Ft Sam Houston , TX 78234 · Duties: Serve as a clinical liaison to communicate information and feedback between METC programs, Program Clinical Coordinators, METC Clinical Coordinator, Dean of Academic Affairs, Associat ...

  • CAPPS, Inc.

    TVC - Claims Benefit Advisor (Veteran Services Representative I)

    Found in: Lensa US 4 C2 - 1 day ago

    CAPPS, Inc. Houston, United States

    Job Description · Please Note: All applications must contain complete job histories, which includes job title, dates of employment, name of employer, supervisor's name and phone number, and a description of duties performed. To receive Military Employment preference, a copy of t ...

  • University Of Houston

    Director- Preceptor Recruitment and Clinical Affiliations

    Found in: Lensa US 4 C2 - 2 days ago

    University Of Houston Houston, United States

    · The Director, Preceptor Recruitment and Clinical Affiliations is a key member of the Medical Education team at the Tilman J. Ferttita Family College of Medicine. In collaboration with senior leadership, this role is responsible for Voluntary/Preceptor Faculty Recruitment and m ...

  • KurzSolutions

    Psychiatrist (Medical Doctor)

    Found in: Jooble US O C2 - 3 days ago

    KurzSolutions Houston, TX, United States

    The Community - Houston, TXAlive with energy and rich in diversity, Houston is a dynamic mix of imagination, talent and first-class attractions that makes it a world-class city. Home to a vibrant economy, beautiful surroundings and a population full of optimism and spirit, it's n ...

  • Fooda

    Dining Associate

    Found in: Lensa US 4 C2 - 2 days ago

    Fooda Houston, United States

    **Dining Associate - Dishwasher** · Houston, TX · Part Time · Operations · Entry Level · **Who We Are:** · We believe a workplace food program is something employees should love and look forward to every day. Powered by technology and a network of over 2,000 restaurants, Fo ...

  • TallGrass

    Director-Government & Public Affairs

    Found in: Lensa US 4 C2 - 1 day ago

    TallGrass Houston, United States

    Tallgrass was named one of the 2023 Top Workplaces USA and highlighted in Colorado's Top Workplaces for the past seven consecutive years. Tallgrass is a leading energy infrastructure company focused on safely, reliably, and sustainably delivering the energy and services that powe ...

  • American Bureau of Shipping

    Regulatory Affairs Manager

    Found in: Lensa US 4 C2 - 4 days ago

    American Bureau of Shipping Houston, United States

    Job Description · The Regulatory Affairs Manager promotes the consistent and proper application of international marine regulations, fulfilling International Association of Classification Societies (IACS) obligations and effectively liaising with regulatory agencies. The Regulat ...

  • KurzSolutions

    Physician / Psychiatry / Texas / Permanent / Psychiatrist Job

    Found in: Jooble US O C2 - 3 days ago

    KurzSolutions Houston, TX, United States

    Job Description Psychiatrist - MD/DOInternational appeal and Southern charm The Community - Houston, TXAlive with energy and rich in diversity, Houston is a dynamic mix of imagination, talent and first-class attractions that makes it a world-class city. Home to a vibrant economy ...

  • FS Bulider Resources

    Warehouse Associate-Flooring Services, Jersey Village

    Found in: Lensa US 4 C2 - 2 days ago

    FS Bulider Resources Houston, United States

    Flooring Services has continued to be a trusted and respected industry leader in the home building industry since 1983. Our family of companies bring the Family Advantage, and we conduct our affairs with integrity while demonstrating respect for our clients, employees, the enviro ...

  • Select Medical

    Physical Therapist

    Found in: Careerbuilder One Red US C2 - 6 hours ago

    Select Medical Houston, TX, United States Full time

    Select Medical is seeking a Physical Therapist for a job in Houston, Texas. · Job Description & Requirements · Specialty: Physical Therapist · Discipline: Therapy · Duration: Ongoing · Employment Type: Staff · Overview · Select Physical Therapy is seeking an outpatient Physical T ...

  • Select Medical

    Physical Therapist

    Found in: Careerbuilder One Red US C2 - 6 hours ago

    Select Medical Houston, TX, United States Full time

    Select Medical is seeking a Physical Therapist for a job in Houston, Texas. · Job Description & Requirements · Specialty: Physical Therapist · Discipline: Therapy · Duration: Ongoing · Employment Type: Staff · Overview · Select Physical Therapy is seeking an outpatient Physical T ...

  • Select Medical

    Physical Therapist

    Found in: Careerbuilder One Red US C2 - 6 hours ago

    Select Medical Houston, TX, United States Full time

    Select Medical is seeking a Physical Therapist for a job in Houston, Texas. · Job Description & Requirements · Specialty: Physical Therapist · Discipline: Therapy · Duration: Ongoing · Employment Type: Staff · Overview · Select Physical Therapy is seeking an outpatient Physical T ...

  • Select Medical

    Physical Therapist

    Found in: Careerbuilder One Red US C2 - 6 hours ago

    Select Medical Houston, TX, United States Full time

    Select Medical is seeking a Physical Therapist for a job in Houston, Texas. · Job Description & Requirements · Specialty: Physical Therapist · Discipline: Therapy · Duration: Ongoing · Employment Type: Staff · Overview · Select Physical Therapy is seeking an outpatient Physical T ...

  • Select Medical

    Physical Therapist

    Found in: Careerbuilder One Red US C2 - 6 hours ago

    Select Medical Houston, TX, United States Full time

    Select Medical is seeking a Physical Therapist for a job in Houston, Texas. · Job Description & Requirements · Specialty: Physical Therapist · Discipline: Therapy · Duration: Ongoing · Employment Type: Staff · Overview · Select Physical Therapy is seeking an outpatient Physical T ...