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Clinical Research Nurse

Company: Headlands Research
Location: Orlando
Posted on: May 16, 2022

Job Description:

The Company
At Headlands Research, we are building the best clinical trial company in the world. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.

This new Clinical Research Nurse role will be based at our site in Orlando, FL and is a full-time position.
You can read more about us at headlandsresearch.com.

The Role

The Clinical Research Nurse, under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations and Institutional Review Board (IRB) approvals. This position is primarily responsible for the accurate administration of investigational products via intravenous therapy and injections, completion of visit procedures and collection of information from study patients according to protocols and for protecting the health, safety, and welfare of research participants. In addition, the clinical trial nurse also acts as study coordinator for limited studies or limited capacity.

Essential Functions: Providing nursing care to research study patients:

--- Ensures compliance with each study's protocol by providing thorough review and documentation at each subject study visit
--- Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
--- Performs medical tests, including, but not limited to, vital signs, imaging studies including fibroscans, and electrocardiograms
--- Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies Principle Investigator of findings/issues.
--- Responsible for the insertion and maintenance of the IV line as well as the care of the patient receiving the therapy.
---Manage all nurse functions of the Infusion suite, including IV pump inventory and basic equipment troubleshooting.
---Assess patient's tolerance to IP administered intravenously, ensuring a plan of action is in place for infusion reactions.
--- Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
--- Documents medical data in patient chart to capture protocol requirements as Study Coordinator, ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines:
--- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
--- Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Headlands databases.
--- Interfaces with research participants, to support efforts to determine eligibility and consenting of study participants according to protocol
--- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
--- Ensures compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability.
--- Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants
--- Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
--- Occasional travel to attend sponsor study training meetings as required
--- Other duties as assigned

Qualifications:
- Valid RN license from the State of Florida (BSN preferred)
- Two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting (Bachelor's degree may be substituted for one (1) year work experience)
- Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, IV insertion, etc.)
- At least one (1) year clinical trials research experience preferred
- At least 1 year experience in infusion therapy or relevant role required
- Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials and GCP concepts
- Detail oriented and meticulous in all aspects of work
- Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
- Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers
- Ability to work well independently as well as in team environment --- Strong interpersonal, customer service and multi-tasking skills are critical
- Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
- Possess the ability to work well under pressure, multi-task, and manage deadlines
- Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures

Keywords: Headlands Research, Orlando , Clinical Research Nurse, Healthcare , Orlando, Florida

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