JOB SUMMARY:

The Research Nurse II manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to ensure compliance with regulations. Implements research protocols per study requirements. Independently and competently performs the nursing process, including assessment, planning, evaluation, and intervention; safeguards the rights and well-being of the study participant; and provides general operational support and administrative duties related to clinical activities for research study.

DISTINGUISHING CHARACTERISTICS:

The Research Nurse II is a highly collaborative, self-motivated, creative person that is adaptable to new processes with capacity to function independently.

This is a Grant Funded position.

Essential Duties Summary

* Applies knowledge in contributing to Good Clinical Practice (GCP) and/or other regulatory activities.

* Under PI's direction, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor.

* Attends and participates in the Investigator meeting.

* Reviews goals and requirements of any new protocols and coordinates study initiation.

* Coordinates the process of clinical research.

* Recruits, screens, enroll, and evaluate patients who participate in study.

* Conducts studies according to protocol and completes case report forms.

* Educates subjects on the details of the studies and ensures that clinical studies are conducted in accordance with the guidelines of the FDA and other regulating agencies.

* Obtains vital signs and performs phlebotomy; monitors participants labs; maintains temperature and QC logs per protocol compliance.

* Serve as liaison between patients, PI, sponsors, and other health professionals and communicates information concerning patient needs and/or changes.

* Develops the clinical trial agreement.

* Answers IRB stipulations to obtain final approval; documents IRB approval and contract approval.

* Plans and designs of source documents for protocol; coordinates study initiation;

* Organizes, facilitates, and obtains Informed Consent from study participant and documents appropriately.

* Completes initial patient assessment utilizing interview, observation, and examination.

* Performs competent physical, pathophysiological, psychosocial, cultural, spiritual, learning needs, and/or age-appropriate nursing assessment of participants.

* Serves as a resource to staff Provides performance management for staff.

* Precepts new clinical research staff and educates research staff.

* Identifies areas of health promotion and patient and family educational needs regarding treatment and follow-up on specific clinical research.

* Completes accurate and concise documentation on all participant records in addition to other source documentation and forms per protocol including maintaining drug documentation.

* Identifies relevant data from internal and external sources and develops and maintains productive working relationship with study monitor.

* Ensures return of test article / clinical supplies; reconciles study drug accountability; assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment.

* Adheres to internal controls established for the department.

* Elicits relevant data from sources outside of the hospital.

* Assists PI in budget development; may monitor ledgers.

* Performs administrative/clinical functions under direction of PI and other related duties as required.

% FTE

1.0

Hiring Range Commensurate with experience. Education

Registered Nurse plus minimum two years of professional nursing experience in direct patient care or research in approved specialty area.

Required Licensing/Certification

Licensed by the State of Texas to practice as a Registered Nurse.

Knowledge, Skills, and Abilities

Skill in:

* Demonstrated skills in computer software applications (e.g., Microsoft outlook, Teams, office 365).

* Ability to work independently, collaboratively, and exercise sound judgment.

* Detail oriented, Problem-solving, decision-making, multitasking and time management.

* Excellent communication, both verbal and written, with strong public speaking skills.

* Demonstrated experience in effective conflict management and resolution.

Ability to:

* Ability to learn and adapt to new processes and adhere to organizational objectives.

* Able to work in a team and produce quality output under tight deadlines.

Work Experience

* Minimum two years of professional nursing experience in direct patient care or research in approved specialty area.

* Bilingual e.g.: Spanish, Asian dialects, etc. preferred.

Working/Environmental Conditions

* Routine office environment, Sitting or standing in one location much of the time.

* Standard hospital, clinical, laboratory and/or office environments.

* Willingness to work flexible hours to meet the needs of the program.

* Report directly to the Program Director/Principal investigator. Works closely with the team to prepare reports and deliverables to funding agency.

* Some travel locally and around greater Houston area (~45%) with mileage reimbursement.

Desired start date Position End Date (if temporary)