Job Ref: 20285
Talent Area: Research - Clinical
Houston Methodist Research Institute
Houston, TX 77030
Area/Department: Structural Heart Dis_Interv
Employment Type: Regular
Job Type: Full-Time
Organization: Houston Methodist
Work Shift: DAY
Work Week: M - F
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 440,000 square foot building dedicated to research, the research institute houses over 1,150 staff members, 270 principal investigators and has more than 600 ongoing clinical trials.
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
Bachelors 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.)
Patient care unit conditions
Universal precautions required
Significant potential for exposure to Latex
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.