Clinical Training Coordinator II

3 weeks ago

Houston, United States DM Clinical Research Full time
Job DescriptionJob DescriptionClinical Training Coordinator II (Travel)

The CTC II or (CRC II) will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CTCII is responsible for developing and delivering training that achieves improved performance and skills. The CTC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES
  • Completes all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA
  • Certification on a timely basis.
  • Completes all the relevant training prior to study-start and on a continued basis in a timely manner. This will
  • include but is not limited to:
    • Sponsor-provided and IRB-approved Protocol Training
    • All relevant Protocol Amendments Training
    • Knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders (ISF) for their assigned protocol(s) at their respective site(s).
    • Any study-specific Manuals Training, as applicable
    • Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
  • Collaborates with HR, Organizational Development and Central Service teams to deliver training to site staff.
  • Conducts ongoing training efforts for staff based on needs found in performance evaluations, career development plans, performance improvement plans and other plans set by management.
  • Delivers ongoing training based on QC, QA and Central Services data trends as well as monitoring report trends.
  • Manages and coordinates Site DM training materials
  • Assists Site Management in leading and coordinating internal staff training sessions.
  • Conducts training for teams to reduce quality related problems and increase understanding of our culture of quality
  • Conducts study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
  • Adheres to ALCOA-C Standards with all the relevant clinical trial documentation.
  • Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
  • Liaises with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research
  • Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
  • Demonstrates adherence and compliance to the assigned protocols.
  • Maintains a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational
  • SOPs, all the guidance documents, and assigned study protocol(s)
  • Maintains a working knowledge of the most recent versions of the Study Protocols, Informed consents,
  • Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
  • Oversees reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
  • Completes data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
  • Strives to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
  • Is prepared for and available at all required company meetings.
  • Submits required administrative paperwork per company timelines; Training documentation, travel arrangements, invoices & itinerary submissions, Evaluations, Mentorships.
  • Conducts patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
  • Provides clear explanations of study protocols and ensure patients' understanding before obtaining their consent
  • Facilitates effective communication between patients, healthcare providers, and research staff
  • Assignment may include an unblinded, uCRC, role. Adhere to ALCOA-C Standards.
  • Adheres to company Travel Policies
  • Is responsible for handling company credit card and/or following the organization’s reimbursement process
  • Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:
  • BA/BS in health, life sciences or similar field or four years of experience in clinical trials research setting may substitute
  • Foreign Medical Doctor Degree Preferred
Experience:
  • At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
  • Minimum two years of clinical trials research training and/or presentation experience preferred
Credentials:
  • ACRP or equivalent certification is preferred
Knowledge and Skills:
  • Comprehensive knowledge of and proficiency using electronic data capture systems and an ability to learn new software quickly
  • Proven ability to use sound judgment and diplomacy while interacting with staff and participating study sites
  • Ability to lead and teach cross-functional groups and site personnel preferred
  • Be goals-driven while continuously maintaining quality.
  • Proficient communication and comprehension skills both verbal and written in the English language are required.
  • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

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