Clinical Research Manager

University of Florida

1d•$84,000 - $92,000

About The Position

40% Plan and direct assigned clinical research trials and projects in the clinical setting: Advise principal investigator by planning and conducting the nursing protocol portion of the research protocol. Maintain compliance with Good Clinical Practice guidelines and Food and Drug Administration’s regulations on all research activities. Manage recruitment with the CTSI recruitment center and PI/HST teams with the recruitment of study subjects including identifying appropriate subjects, determining eligibility, obtaining informed consent, and enroll patients in study. Coordinate the collection of research data; create data collection tools through applications such asREDCap. Explain research protocol to participants; respond to patient inquiries regarding protocol; schedule patient participation; ensure compliance with research protocol 40% Direct education and nursing care in support of clinical research trials and projects in clinical settings: Provide clinical care to participants enrolled in clinical trials. Administer treatments and/or investigational medications in accordance with research protocols. Initiate ordering of necessary tests, equipment and medications per protocol. Perform specialized tasks such as pharmacokinetic sampling, euglycemic clamp procedures, administration of conscious sedation; assisting with invasive procedures such as liver biopsies and bronchoscopies. Collect body fluid specimens, including timed specimens for pharmacokinetic assessments. Processes specimens for storage and shipping as required by protocol. 15% Provide Administrative support to assigned research trials and projects: Provide administrative support to NIH’s WEBCamp scheduling and data tracking system. Maintain detailed records of clinical research trials and projects, including data collection, while maintaining HIPAA compliance standards regarding patient confidentiality. Alert Principal Investigator(s) to any Adverse Events/Serious Adverse Events for timely reporting to the IRB when appropriate.

Requirements

Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.

Nice To Haves

Four years of nursing experience in a clinical research setting.
ACLS certification.
Knowledgeable regarding IRB procedures, forms and approval process
Knowledge of nursing principles, practices and techniques
Knowledge of basic principles and good clinical practice of clinical research
Experience coordinating clinical research studies
Skill in the use of nursing equipment and instruments
Ability to collect, collate, analyze and evaluate data from clinical research studies
Ability to plan, organize and coordinate work assignments
Ability to work effectively and independently
Ability to communicate effectively, both verbally and in writing
Expertise in phlebotomy

Responsibilities

Plan and direct assigned clinical research trials and projects in the clinical setting
Advise principal investigator by planning and conducting the nursing protocol portion of the research protocol.
Maintain compliance with Good Clinical Practice guidelines and Food and Drug Administration’s regulations on all research activities.
Manage recruitment with the CTSI recruitment center and PI/HST teams with the recruitment of study subjects including identifying appropriate subjects, determining eligibility, obtaining informed consent, and enroll patients in study.
Coordinate the collection of research data; create data collection tools through applications such asREDCap.
Explain research protocol to participants; respond to patient inquiries regarding protocol; schedule patient participation; ensure compliance with research protocol
Direct education and nursing care in support of clinical research trials and projects in clinical settings
Provide clinical care to participants enrolled in clinical trials.
Administer treatments and/or investigational medications in accordance with research protocols.
Initiate ordering of necessary tests, equipment and medications per protocol.
Perform specialized tasks such as pharmacokinetic sampling, euglycemic clamp procedures, administration of conscious sedation; assisting with invasive procedures such as liver biopsies and bronchoscopies.
Collect body fluid specimens, including timed specimens for pharmacokinetic assessments.
Processes specimens for storage and shipping as required by protocol.
Provide Administrative support to assigned research trials and projects
Provide administrative support to NIH’s WEBCamp scheduling and data tracking system.
Maintain detailed records of clinical research trials and projects, including data collection, while maintaining HIPAA compliance standards regarding patient confidentiality.
Alert Principal Investigator(s) to any Adverse Events/Serious Adverse Events for timely reporting to the IRB when appropriate.