Work Shift: DAY
Work Week: M - F
Since its founding in 1919, Houston Methodist Hospital has earned worldwide recognition. Houston Methodist Hospital is affiliated with the Weill Medical College of Cornell University and New York-Presbyterian Hospital, one of the nation's leading centers for medical education and research. Houston Methodist is consistently ranked in U.S. News & World Report’s “Best Hospital” list and was recently named the number one hospital in Texas. FORTUNE magazine has placed Houston Methodist on its annual list of “100 Best Companies To Work For” since 2006. Houston Methodist Hospital directs millions of research dollars into patient care and offers the latest innovations in medical, surgical and diagnostic techniques. With 1,119 licensed beds, 67 operating rooms and over 6,000 employees, Houston Methodist offers complete care for patients from around the world.
With minimal supervision, manages complex research projects that may involve sites and/or the supervision of research activities. Implements research protocols, including screening and enrolling subjects, obtaining blood and other specimens for tests. Administering medications and maintaining pertinent patient records. Obtain, record, validate and interpret data to achieve the goals of the research project. Serves as a liaison between physicians, patients, staff and sponsors.
PATIENT AGE GROUP SERVED
Direct patient care.
DUTIES AND RESPONSIBILITIES:
- With minimal supervision, demonstrates ability to manage multiple projects at different stages of the clinical research process (Phase 1-Phase 4)
- With minimal supervision, prepares IRB and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate. Follows ICH/GCP guidelines.
- Coordinates pre-site and site initiation visits; trains hospital and clinic nurses/physicians on scientific aspects and protocol requirements of research studies. Attends off-site investigator meetings.
- Assists with development of study tools including sources documents and eligibility checklists and criteria cards.
- Assists with budget development and institutional account reconciliation of protocol-driven ancillary procedures and tests.
- Assisting financial analyst selecting standard of care procedures vs. research and approving study calendars for CTMS
- Identifies, recruits, and consents clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies, as necessary.
- Provides comprehensive nursing assessments to develop, coordinate, implement and evaluate activities associated with all phases of clinical research projects. Monitors safety of all research subjects and reports adverse events.
- Performs nursing functions independently and in collaboration with Principal Investigator as approved by Hospital administration for the conduct of clinical research.
- Provides patient education regarding disease process and involves patient and family in decision-making processes.
- Collects and enters study data on manual or electronic case report forms according to prescribed standards.
- Enters all required data into CTMS.
- Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification.
- Maintains inventory and accountability of investigational products and supplies; maintains appropriate logs.
- Monitors source documents and case report forms for completion and accuracy; assists with quality assurance processes.
- Perform study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.
- Precept new clinical research staff in clinical setting.
- Maintains accountability for ongoing professional growth and development. Participates in unit activities.
- Assist with billing process.
- Performs other duties as assigned.
- Associate Degree in Nursing required
- Bachelor’s Degree preferred
- Minimum of 1 to 5 years of experience required
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED:
- Current Registered Nurse Licensure in the State of Texas
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
- Supervisory experience required.
- Requires highly effective communication skills.
- Requires highly effective time management skills
- Requires ability to understand and implement protocols.
- Requires experience with computer database management.
- Requires Microsoft Office skills.
- Requires strong interpersonal skills.
- Extended periods of walking and standing may be required.
- Lifting, pushing or pulling required (minimum 50 lbs.)
- An Activity Checklist (see final page)
- Patient care unit conditions
- Universal precautions required
- Significant potential for exposure to Latex
Equal Employment Opportunity
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law.
VEVRAA Federal Contractor – priority referral Protected Veterans requested.