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, thorough documentation, and the safety of research participants. Responsibilities include gathering patient information for clinical research activities in accordance with the study protocol and performing general administrative tasks to support the research efforts.

Key Responsibilities:

PEOPLE ESSENTIAL FUNCTIONS
Collaborates with the Principal Investigator (PI) to draft communications and regulatory documents for submission to sponsors. Identifies and recruits subjects for clinical research, monitoring enrollment targets closely. May conduct training sessions for nursing staff and physicians; assists in mentoring new research personnel and educating team members on the scientific components of studies. Encourages critical thinking among peers by articulating the rationale behind decisions and consistently following up. Promotes accountability among colleagues to enhance departmental performance metrics. SERVICE ESSENTIAL FUNCTIONS
Engages in meetings with the Principal Investigator (PI) to discuss study progress. Organizes and participates in pre-site and site initiation visits; oversees the commencement of studies. Secures informed consent from participants and documents the process accurately. Measures vital signs and performs phlebotomy as per training; monitors laboratory results and communicates findings to the PI. QUALITY/SAFETY ESSENTIAL FUNCTIONS
Prepares Institutional Review Board (IRB) documentation under the guidance of the PI, assists in addressing IRB stipulations to secure final approval; maintains records of IRB and contract approvals. Maintains and oversees source documentation and necessary forms in accordance with protocol for quality assurance, including participant records; aids in the quality assurance process. Adheres to established internal controls for the department. FINANCE ESSENTIAL FUNCTIONS
Assists in developing budgets and conducting Medicare coverage analyses. Utilizes resources efficiently, demonstrating responsible financial management. Effectively manages time and prioritizes tasks to achieve optimal results. GROWTH/INNOVATION ESSENTIAL FUNCTIONS Aids the PI and/or research nurse in designing source documents for protocols. Contributes to the development of procedures for laboratory specimen collection and storage. Integrates insights from various healthcare disciplines into clinical research protocols when assessing patient eligibility; assists in gathering relevant data from external sources. Actively pursues professional development and completes personal development plans. This job description is not exhaustive; the employee may also undertake other related duties as assigned. Houston Methodist reserves the right to modify job responsibilities as necessary.

Qualifications:

EDUCATION
Bachelor's degree WORK EXPERIENCE
Four years of experience in research LICENSES AND CERTIFICATIONS - REQUIRED
N/A LICENSES AND CERTIFICATIONS - PREFERRED
CCRC - Certified Clinical Research Coordinator (ACRP) within 1 year OR CCRP - Certified Clinical Research Professional (SOCRA) within 1 year

KNOWLEDGE, SKILLS, AND ABILITIES

Demonstrates the necessary skills and competencies to safely perform assigned tasks, evaluated through ongoing assessments and performance reviews. Proficient in English, with the ability to communicate effectively in writing and verbally, particularly regarding patient and employee safety. Capable of effectively interacting with patients, healthcare providers, family members, and colleagues, emphasizing a customer service approach and positive communication principles. Able to work independently and manage challenging situations effectively. Exhibits sound judgment and possesses strong analytical skills.

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