The Senior Research Coordinator for the Center for Cell and Gene Therapy assists the Principal Investigators in conducting oncology clinical trials, primarily at Houston Methodist Hospital. The Sr. Research Coordinator is responsible for the daily research activities, which includes scheduling, screening, enrollment and monitoring of research patients. The Sr. Research Coordinator works closely with the PIs, managers, regulatory staff, investigational pharmacies and the sponsors to ensure the research studies are performed in accordance with federal regulations, departmental policies, and within the sponsors' guidelines.
This is an onsite role with potential to work one day a week remotely.
Serves as the primary lead coordinator for sponsored studies at Methodist Hospital.
Interviews, screens and recruits potential study patients. Educates the patients and medical staff in the required procedures and time commitments for participation in research studies.
Develops and maintains detailed study spreadsheets, collects source documentation from the hospital’s EMR/Epic and organizes research charts.
Reviews protocol documents, informed consents, lab manuals and research budgets.
Performs cognitive and frailty assessments on study patients as directed by the research protocol.
Creates clinical research order sets for the hospital’s EMR/Epic, to expedite the ordering process for new clinical trials.
Collects, processes, ships, and maintains paperwork for blood and/or biological specimens according to the research protocol.
Coordinates with the nurse practitioners to schedule research visits as required by the protocol.
Reports study patient results to the sponsor and PI, ensuring accurate and timely data reporting.
Responsible for the data entry into data systems, iMedidata RAVE, eClinical, OnCore, FormsNet, IBM Development, and RedCap.
Prepares research studies for audits and monitoring visits (remote & on-site).
Orders research supplies and equipment.
Maintains investigational drug accountability logs and correlates logs with pharmacy for accuracy.
Directs and assists with the training of less experienced research staff.
Administers questionnaires (in person or over the phone/video conference) and conducts patient interviews and assessments at multiple time points as outlined in the research protocol.
Participates in teleconferences and initiation visits/investigator’s meetings for assigned clinical trials (may involve travel).
Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
Five years of relevant experience.
Experience in managing oncology clinical trials is a plus but not required
Experience in pharmaceutical and BMT CTN sponsored studies
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
CA; CH; SN
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