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Clinical Research Coordinator II
2 months ago
At Houston Methodist, the Clinical Research Coordinator II role is pivotal in managing the daily operations of research protocols while evaluating and determining patient eligibility for various research studies.
With minimal oversight, this position ensures precise data collection, thorough documentation, and the safety of research participants. Responsibilities include gathering patient data for clinical research activities through methods outlined in the study protocol, alongside performing general administrative tasks that support the study.
Key Responsibilities
Under the guidance of the Principal Investigator (PI), this role involves drafting communications with sponsors and regulatory documents. The coordinator identifies and recruits clinical research subjects, monitoring enrollment targets.
Additionally, the coordinator may conduct training sessions for floor nurses and physicians, assist in mentoring new clinical research staff, and educate colleagues on the scientific aspects of studies. The role emphasizes peer accountability to enhance departmental performance in turnover, retention, and employee engagement.
Service Functions
Participation in PI meetings is essential. The coordinator schedules, coordinates, and engages in pre-site and site initiation visits, ensuring study initiation processes are followed. Obtaining informed consent from study participants and documenting it accurately is a critical task.
Vital signs collection and phlebotomy are performed as per training, with ongoing monitoring of participants' laboratory results and timely communication of findings to the PI.
Quality and Safety Functions
Preparation of Institutional Review Board (IRB) documents under the PI's direction is required, including addressing IRB stipulations for final approval. The coordinator maintains and oversees source documentation and relevant forms to ensure quality and accuracy, assisting in the quality assurance process.
Adherence to established internal controls for the department is mandatory.
Financial Responsibilities
Assistance with budget development and Medicare coverage analysis is part of the role. The coordinator is expected to utilize resources effectively, demonstrating responsible financial stewardship while managing time efficiently to achieve optimal results.
Growth and Innovation Functions
Collaboration with the PI and/or research nurse in planning and designing source documents for protocols is encouraged. The coordinator aids in developing procedures for laboratory collection and storage.
Incorporating insights from various healthcare disciplines into clinical research protocols when assessing patient eligibility is vital, as is the proactive management of personal professional development.
This job description is not exhaustive; the employee may perform other related duties as assigned. Houston Methodist reserves the right to modify job duties and responsibilities as necessary.
Qualifications
Education: Bachelor's degree required.
Experience: Minimum of four years in research.
Licenses and Certifications: N/A (Preferred: CCRC or CCRP within one year).
Knowledge, Skills, and Abilities: The candidate must demonstrate the competencies necessary for safe job performance, possess sufficient proficiency in English, and exhibit effective communication skills with patients, physicians, and colleagues.
Ability to work independently and manage challenging situations is essential, alongside sound judgment and analytical skills.
Supplemental Requirements
Work Attire: Scrubs required; uniforms and business professional attire not applicable.
On-Call: No.
Travel: Specifications may vary by department.
Company Overview
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, supporting a vast network of faculty and learners. The Academic Institute aligns research and education initiatives to enhance clinical missions, providing innovative solutions for patient care.
The Education Institute coordinates primary academic affiliations and oversees continuing medical education, supporting numerous trainees across various healthcare education programs.
The Research Institute facilitates research programs that enable faculty to translate scientific discoveries into patient care efficiently, managing a significant number of clinical research protocols and funding for translational research.
Houston Methodist is an equal opportunity employer, committed to inclusivity and diversity in the workplace.
