Work Shift: DAY
Work Week: M - F
Coordinates research study and gathers patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.PATIENT AGE GROUP SERVED
DUTIES AND RESPONSIBILITIES
- Under the direction of the Principal Investigator (PI), draft 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.
- Obtains Informed Consent from study participant and documents appropriately.
- Participate in the Investigator meetings.
- Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation.
- When appropriately trained and tested for competency, obtains vital signs and performs phlebotomy; monitors participants' labs and notifies the PI of laboratory findings.
- Prepares IRB documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
- 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.
- 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.
- Assists with the budget development and Medicare Coverage Analysis.
- Assist 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.
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.
Minimum 2 years of research experience
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
CCRC or CCRP preferred.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
- Knowledge in relevant therapeutic area preferred
- Time management skills
- Ability to understand and implement protocols
- Experience with computer database management
- Knowledge of Microsoft Office
- Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security.
- Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles.
Patient care unit conditions
Some assignments may be in hospital units or laboratory with typical hospital environmental hazards and concerns
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.
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 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials.
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