Clinical Training Specialist II

2 weeks ago

Houston, Texas, United States DM Clinical Research Full time
Job Overview

The Clinical Training Coordinator II (Travel) is pivotal in ensuring that high-quality research is executed at designated investigative sites, adhering to sponsor protocols, FDA regulations, and ICH/GCP guidelines. This role is dedicated to enhancing the performance and skills of the research staff through effective training programs. Additionally, the CTC II is responsible for achieving study enrollment targets that align with sponsor expectations, ensuring that organizational objectives are met promptly.

Key Responsibilities
  • Complete all required training as mandated by DMCR, including ICH-GCP Certification and IATA.
  • Ensure all relevant training is finalized before the commencement of studies and maintained consistently thereafter.
  • Conduct training sessions on:
    • Sponsor-provided and IRB-approved Protocol Training
    • All relevant Protocol Amendments Training
    • Essential Clinical Trial Documents and upkeep of Investigator Site Binders (ISF) for assigned protocols.
    • Study-specific Manuals Training, as necessary
    • Sponsor-specified EDC and/or IVRS training, along with other relevant electronic systems.
  • Collaborate with HR, Organizational Development, and Central Service teams to provide training to site personnel.
  • Facilitate ongoing training initiatives based on performance evaluations, career development plans, and management directives.
  • Deliver continuous training informed by quality control, quality assurance, and central services data trends.
  • Manage and coordinate Site DM training materials effectively.
  • Assist Site Management in leading and organizing internal training sessions.
  • Conduct training aimed at minimizing quality-related issues and fostering a culture of quality.
  • Perform study subject visits and document all protocol-required procedures promptly.
  • Adhere to ALCOA-C Standards in all clinical trial documentation.
  • Exhibit a comprehensive understanding of Laboratory Manuals and protocol-specific laboratory procedures.
  • Coordinate with Laboratory, Data, Administrative staff, Clinical Investigators, Research Participants, and Sponsor/CRO representatives.
  • Ensure compliance with assigned protocols and maintain a thorough knowledge of current FDA regulations, ICH-GCP guidelines, and organizational SOPs.
  • Oversee the reporting of Adverse and Serious Adverse Events and relevant Safety Information in accordance with internal guidelines.
  • Complete data entry and query resolution promptly, adhering to internal and sponsor expectations.
  • Strive to meet subject enrollment goals for assigned protocols.
  • Participate in all required company meetings and submit necessary administrative documentation on time.
  • Facilitate patient consent discussions, ensuring understanding of medical procedures, risks, benefits, and alternatives.
  • Provide clear explanations of study protocols to ensure patient comprehension before obtaining consent.
  • Foster effective communication among patients, healthcare providers, and research staff.
  • Adhere to company travel policies and manage company credit card usage or reimbursement processes.
  • Perform any additional tasks as assigned by management.
Qualifications

Education:

  • BA/BS in health, life sciences, or a related field, or four years of relevant experience in a clinical trials research environment.
  • Foreign Medical Doctor Degree is preferred.

Experience:

  • A minimum of 2 years of experience as a Clinical Research Coordinator, ideally with a focus on coordinating industry-sponsored vaccine trials.
  • At least two years of clinical trials research training and/or presentation experience is preferred.

Credentials:

  • ACRP or equivalent certification is preferred.

Knowledge and Skills:

  • Extensive knowledge of electronic data capture systems and a quick adaptability to new software.
  • Ability to exercise sound judgment and diplomacy in interactions with staff and study sites.
  • Capability to lead and instruct cross-functional teams and site personnel.
  • Goal-oriented while consistently upholding quality standards.
  • Strong verbal and written communication skills in English are required; bilingual proficiency in English and Spanish is preferred.

Powered by JazzHR

TvUWNLYLBR

  • Clinical Training Specialist II

    2 weeks ago

    Houston, Texas, United States DM Clinical Research Full time

    Job OverviewThe Clinical Training Coordinator II (Travel) is responsible for ensuring that high-quality research is conducted at designated investigative sites, adhering to sponsor protocols, FDA regulations, and ICH/GCP guidelines. This role is pivotal in delivering superior quality data to sponsors and enhancing the performance and skills of site staff...

  • Clinical Training Specialist II

    2 weeks ago

    Houston, Texas, United States DM Clinical Research Full time

    Job OverviewThe Clinical Training Coordinator II (Travel) plays a crucial role in ensuring that high-quality research is conducted at designated investigative sites, adhering to sponsor protocols, FDA regulations, and ICH/GCP guidelines. This position is essential for delivering superior quality data to sponsors and enhancing the performance and skills of...

  • Clinical Nutrition Specialist II

    2 weeks ago

    Houston, Texas, United States Catholic Health Initiatives Full time

    OverviewCatholic Health Initiatives is a prominent healthcare organization committed to delivering exceptional patient care and advancing clinical practices. Our facilities are designed to foster an environment that prioritizes patient safety and comfort, while also supporting innovative research and education. We are dedicated to enhancing healthcare access...

  • Clinical Research Specialist II

    2 weeks ago

    Houston, Texas, United States Houston Methodist Full time

    Clinical Research Specialist II - Oncology Trials At Houston Methodist, the Clinical Research Specialist II role is pivotal in orchestrating the daily operations of clinical research protocols while evaluating and determining patient eligibility for various studies. This position operates with a degree of autonomy, ensuring precise data collection,...

  • Clinical Nurse Specialist II

    7 days ago

    Houston, Texas, United States Harris Health Full time

    POSITION OVERVIEW:The Clinical Nurse Specialist II (CNS II) plays a crucial role in delivering exceptional patient care in alignment with the Texas Nursing Practice Act and the standards set forth by Harris Health Nursing Services. The CNS II independently oversees patient management within their designated clinical setting while appropriately seeking...

  • Clinical Support Specialist II

    2 weeks ago

    Houston, Texas, United States UTHealth Houston Full time

    UTHealth Houston stands as a premier institution for healthcare education, innovation, and outstanding patient care. We are currently seeking a Clinical Support Specialist II to enhance our dedicated team within the Neurosciences department.Key Responsibilities:Manage patient communications including calls and messages.Utilize the Epic system for various...

  • Clinical Research Coordinator II

    1 day ago

    Houston, Texas, United States DM Clinical Research Full time

    Job DescriptionClinical Research Coordinator IIThe Clinical Research Coordinator II will be responsible for ensuring the successful execution of clinical trials at assigned investigative sites. This role will involve ensuring compliance with sponsor protocols, FDA regulations, and ICH/GCP guidelines, as well as providing high-quality data to sponsors.Key...

  • Clinical Nutrition Specialist II

    2 weeks ago

    Houston, Texas, United States Catholic Health Initiatives Full time

    OverviewCatholic Health Initiatives is a leader in providing comprehensive healthcare services, committed to enhancing the well-being of our communities through innovative care and research. Our facilities are designed to prioritize patient safety and comfort, ensuring a holistic approach to healthcare that integrates advanced medical practices with...

  • Technical Writer II

    1 day ago

    Houston, Texas, United States Shea Writing and Training Solutions, Inc. Full time

    Job DescriptionJob Title: Technical Writer IIWe are seeking a highly skilled Technical Writer II to join our team at Shea Writing and Training Solutions, Inc. as a Content Specialist.Key Responsibilities:Collaborate with Subject Matter Experts and Technical Specialists to develop, review, revise, and maintain technical documents, including SOPs, policies,...

  • Offshore Marine Training Specialist

    2 weeks ago

    Houston, Texas, United States Maersk Training Full time

    Are you ready to contribute to the premier educational provider in the Offshore Sector? We are seeking a skilled and enthusiastic Offshore Marine Training Specialist to enhance our dedicated team. This role presents an exceptional opportunity to leverage your expertise within a prominent organization in the maritime industry. As our Offshore Marine Training...

  • Technical Writer II

    1 day ago

    Houston, Texas, United States Shea Writing and Training Solutions, Inc. Full time

    Job DescriptionJob Title: Technical Writer IIWe are seeking a skilled Technical Writer II to join our team at Shea Writing and Training Solutions, Inc. as a Content Specialist. As a key member of our documentation team, you will be responsible for creating high-quality technical documents that meet the needs of our clients.Key Responsibilities:Collaborate...

  • Clinical Nutrition Specialist II

    2 weeks ago

    Houston, Texas, United States Catholic Health Initiatives Full time

    Overview Catholic Health Initiatives is a prominent organization dedicated to delivering exceptional healthcare services and advancing medical research. Our commitment to excellence has fostered numerous innovative programs aimed at enhancing patient care and outcomes. We prioritize a holistic approach to healthcare, ensuring that our facilities are designed...

  • Clinical Support Specialist II

    2 weeks ago

    Houston, Texas, United States Team1Medical Full time

    Job OverviewPosition: Clinical Support Specialist IILocation: Houston, TX | Employment Type: Temp-to-hire | Workplace Type: On-siteHealthcare Focus: Orthopedics & Urology | Compensation: $18 - $22 per hourJoin one of the leading clinics specializing in Orthopedics and Urology, where you will play a vital role in delivering exceptional patient care while...

  • Clinical Training Development Specialist

    5 days ago

    Houston, Texas, United States Community Health Choice Full time

    JOB SUMMARYThe Clinical Training Development Specialist - RN is tasked with partnering with various divisions within the organization to identify and execute training initiatives pertinent to STAR+PLUS. This role involves facilitating essential components of Service Coordination training and ensuring that relevant policies and procedures are integrated into...

  • Senior Clinical Training Specialist

    3 weeks ago

    Houston, Texas, United States tapwage Full time

    Together, we can beat cancer.At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.We are part of an incredible community of scientists, clinicians, developers, researchers,...

  • Traveling MRI Imaging Specialist

    7 days ago

    Houston, Texas, United States Infojini Healthcare II Full time

    Position Overview:Infojini Healthcare II is currently in search of a traveling MRI Imaging Specialist to fill a vital role within our healthcare team.Key Responsibilities:- Perform MRI scans with precision and care.- Ensure patient safety and comfort during procedures.- Collaborate with healthcare professionals to deliver high-quality imaging services.-...

  • Clinical Trials Laboratory Specialist

    7 days ago

    Houston, Texas, United States DM Clinical Research Full time

    Position OverviewThe Clinical Trials Laboratory Specialist plays a pivotal role in executing specialized laboratory tasks for clinical research, utilizing advanced laboratory techniques. This includes, but is not limited to, the routine extraction of peripheral blood mononuclear cells (PBMC), conducting flow cytometry, and isolating DNA/RNA, while adhering...

  • Clinical Training Development Specialist

    5 days ago

    Houston, Texas, United States Community Health Choice Full time

    JOB SUMMARYThe Clinical Training Development Specialist - RN plays a pivotal role in partnering with diverse departments within the organization to pinpoint and execute training initiatives related to STAR+PLUS. This position involves leading essential components of Service Coordination training, ensuring that relevant policies and procedures are effectively...

  • Clinical Training Specialist

    7 days ago

    Houston, Texas, United States Community Health Choice Full time

    JOB SUMMARYThe Clinical Training Specialist - STAR+PLUS is tasked with partnering with various organizational departments to identify and implement training initiatives related to STAR+PLUS. This role involves facilitating essential components of Service Coordination training while ensuring that relevant policies and procedures are integrated into training...

  • Clinical Nutrition Specialist II

    6 days ago

    Houston, Texas, United States Catholic Health Initiatives Full time

    OverviewCatholic Health Initiatives is a prominent healthcare organization dedicated to enhancing patient outcomes through innovative care and clinical excellence. Our commitment to research and advanced treatment methodologies positions us at the forefront of healthcare delivery. Our facilities are designed with a focus on patient safety and comfort,...