Research Coordinator II

At Houston Methodist, this Research Coordinator II position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies in the Houston Methodist Cockrell Center for Advanced Therapeutics. Under minimal supervision, this position is responsible for ensuring accurate data collection, documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the study protocol and performing general administrative and regulatory duties supporting the study.

This position will also support the expanded access program for cellular therapies. The Expanded access program is a potential pathway from the FDA for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. This position will work with the Regulatory Affairs Office, the IRB and the physicians to coordinate the requirements needed for these expanded access requests. This will include working with the treating physician to collect the required documentation, completing IRB submissions, coordinating with the Cellular Therapy Dept, coordinating with clinical infusion center, consenting of patients, and working with treating physician on reporting of required outcome and adverse event reporting.

PEOPLE ESSENTIAL FUNCTIONS

• Under the direction of the Principal Investigator (PI), drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.

• Identifies and recruits clinical research subjects and monitors enrollment goals.

• May conduct in-services to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.

• Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.

SERVICE ESSENTIAL FUNCTIONS

• Participates in the Principal Investigator (PI) meetings.

• Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. Obtains Informed Consent from study participant and documents appropriately.

• Obtains vital signs and performs phlebotomy per training and competence; monitors participants' labs and notifies the PI of laboratory findings.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Prepares Institutional Research Board (IRB) documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.

• Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. Adheres to internal controls established for the department.

FINANCE ESSENTIAL FUNCTIONS

• Assists with the budget development and Medicare coverage analysis.

• Utilizes resources effectively and efficiently, demonstrating responsible financial stewardship. Manages own time effectively and prioritizes work to achieve maximum results in a timely manner.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Assists PI and/or research nurse in the planning and design of source documents for protocol.

• Assists in developing procedures for laboratory collection and storage.

• Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.

• Proactively manages own professional development and completes My Development Plan.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

EDUCATION

• Bachelor's degree

WORK EXPERIENCE

• Four years of research experience