Clinical research specialist [h1.location_city]

ABOUT NCH

NCH is an independent, locally governed non-profit delivering premier comprehensive care. Our healthcare system is comprised of two hospitals, an alliance of 700+ physicians, and medical facilities in dozens of locations throughout Southwest Florida that offer nationally recognized, quality health care.

NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to : Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.

Join our mission to help everyone live a longer, happier, healthier life. We are committed to care and believe there's always more at NCH - for you and every person we serve together. Visit nchjobs.org to learn more.

JOB SUMMARY

The Research RN, NCHRI works directly with the physician in accurately and professionally executing all clinical research projects in an acute care / inpatient setting (ED, Cath Lab, ICU, EP lab, Step down and OR) as well as the ambulatory and ancillary areas. Protocol driven research tasks performed by the physician are guided by the Research Nurse to assure all required steps are completed and performed in the correct order. This position manages the research related care of these patients, assists in project initiation, facilitates patient enrollment, encourages patient retention in trials, reports to sponsors on progress / status, and coordinates study participation with other clinical care plans. The Research RN must possess the knowledge and clinical experience to work in many different areas with numerous teams in order to experience success in this position. Good interpersonal communication skills are essential.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Other duties may be assigned.

Oversees clinical research studies, collecting all clinical data in an accurate and timely manner.

• Performs required procedures and data collection activities at necessary in observational settings such as, ED, Cath Lab, EP Lab, ICU / Step down area, physician office, OR, and other required areas.
• Serves as primary clinical contact person for study sponsor, patient, family, and other healthcare contacts / departments.
• Assures all data points are supported by medical records, physician notes, diagnostic reports, procedural summaries, or research project documents.
• Delivers data that is accurate and complete, matching source and data entry information.
• Facilitates physician oversight of all data, especially adverse event reporting as it relates to study drug, device, or therapy.
• Works with sponsor’s auditor / monitor to review and verify accuracy and completeness of data recorded.
• Delivers data within required timelines per sponsor expectations.

Coordinates critical research tasks and patient activities in accordance with Good Clinical Practice (GCP).

• Serves as the contact for physicians and other caregivers in assuring all research and related clinical needs are met.
• Assists in the initiation and maintenance of accurate protocol processes.
• Verifies that patients are scheduled appropriately for follow up evaluations per protocol.
• Assures patients are well educated as to the importance of compliance with study objectives through ongoing education and reminders.
• Maintains the control of drug / device inventory per log or other acceptable documentation.
• Guides referring physicians in GCP compliance and clinical care through protocol design and awareness through education.
• Makes recommendations on how to facilitate special or acute needs of patients.
• Assists screeners with patient consenting and performs re-consenting when necessary and in accordance with GCP.
• Knows and fulfills IRB / FDA expectations in the execution of these critical tasks.
• Actively participates in any FDA audits that may occur, both in preparation and execution of the process.

Facilitates and maintains high patient enrollment and participation in research protocols.

• Encourages new patient enrollment, working with physicians and screeners to seek out all efforts to facilitate a successful process.
• Works closely with patient, family, and research staff to assure good patient rapport and high-quality clinical care, re-enforcing the desire for patient’s retention in the trial.
• Alerts Manager and physicians of patient withdrawal or continuance issues quickly in the event they might intervene and prevent withdrawal.

Participates directly in-patient care duties associated with the project.

• Maintains required skills and clinical knowledge to manage the wide scope of clinical needs.
• Maintains awareness of all research projects so as to serve as a back-up support as needed.
• Provides nursing knowledge and decision-making support to non-RN research team members seeking support.
• Promotes teamwork and seeks to provide high quality care to all patients.

Serves as a Representative of the NCH Research Institute.

• Performs as a role model to both department and hospital staff, serves as a liaison with physicians and collaborating staff.
• Serves as the primary clinical trial contact person for study sponsor, patient, family, or other healthcare contacts or departments.
• Represents the Research Institute in a professional manner, demonstrating knowledge and enthusiasm for clinical research.
• Serves as an internal and external resource for questions referencing clinical research at NCH.
• Professionally represents Principal Investigator and NCH Research Institute at protocol meetings and conference calls in the absence of the Investigator.

Performs other related duties as required or requested.

• Through observation and reporting, assures NCHRI’s needs are met and action taken as required to deliver best outcomes to its patients.
• Offers support and cooperation as needed.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Minimum of 2 years of experience in Critical Care / Cardiology preferred.
• Licensed as a Registered Nurse (RN) in the State of Florida.
• Basic Life Support (BLS) certification required from the American Red Cross or American Heart Association.
• Strong Communication and Problem-Solving skills and the ability to remain flexible.
• Advanced Life Support (ALS) certification preferred from the American Red Cross or American Heart Association.
• Intermediate computer knowledge : Uses Microsoft Word, Excel, Outlook, and Windows
• Strong organizational skills
• Excellent communication and interpersonal skills.