Clinical Research Nurse Coordinator

Located in TAMPA, FLORIDA

JOB SUMMARY

The Clinical Research Nurse Coordinator (CRNC) role at the Global Alzheimer's Platform Foundation (GAP) site is designed to oversee all delegated tasks involved in the execution of clinical trials, operating under the direct supervision of the Principal Investigator and Site Director. The RNC is expected to possess a comprehensive understanding of protocol requirements and must execute study activities in strict accordance with Good Clinical Practice (GCP) guidelines and federal and state regulations.

As the primary point of contact for the protocols, the research nurse coordinator will serve as a crucial link between the investigators, primary care providers, the Institutional Review Board (IRB), and the sponsor.

Working alongside the investigator, the research nurse coordinator will be responsible for the screening, enrollment, and ongoing monitoring of study subjects, ensuring their adherence to the study protocol and maintaining rigorous oversight throughout their participation in the study.

Moreover, the RNC assumes responsibility for all aspects related to data collection and source documentation, timely reporting of adverse events, the meticulous maintenance of complete investigator files for the site, and investigational drug handling, dispensation, and administration. This multifaceted role is pivotal in ensuring the successful execution of clinical trials and the advancement of Alzheimer's research.

DUTIES

Study Preparation:

• Reviews and assesses protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies

• Discusses study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff

• Responsible for the handling, dispensation of investigational drug which may include preparation, administration, and monitoring of infused product to ensure safety while safeguarding the integrity and quality of clinical trials.

• Ensures adequate supplies have arrived on site for infusion (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords), and maintains site-supplied resources as appropriate

• Assists with planning and creation of appropriate recruitment materials, as well as assists in development of recruitment plans and obtains listing of potential candidates to contact from database

• Actively works with recruitment team in calling and recruiting subjects

• Participates in Investigator’s Meeting (IM), Site Initiation Visits (SIVs), and may coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives

• Creates (or reviews sponsor- provided) protocol specific source documents

• Reviews and determines facility, equipment, and outsource vendor availability

• Ensures adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)

• Works with PI to ensure education of staff and/or sub investigators is completed for required tasks

Study Management:

• Learns to integrate new trials with existing trial load, delegate tasks as necessary, and prioritize activities regarding protocol timelines

• Maintains organized files and supplies including blank source documents and participant charts

• Works with other staff to actively handle investigational product accountability: receives, inventories, dispenses, monitors participant compliance, and re-orders if necessary. Documents on accountability log and participant records

• Integrates monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings

• Ensures trial activities are discussed in advance with covering personnel in case of sick leave or planned time off

• Actively practices and maintains adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials

• Communicates sponsor updates, participant specific concerns/progress, unforeseen issues, and overall trial management with appropriate research staff in an ongoing fashion

• Develops and maintains effective relationships with study participants and their partners

• Interacts in a positive, professional manner with participants, sponsor representatives, outside offices, investigators, and Global Alzheimer’s Platform Foundation (GAP) personnel

• Communicates clearly verbally and in writing

• Accepts accountability for actions and learns to function independently

Participant Coordination:

• Prescreens study candidates by telephone and reviews exclusionary conditions or medications prior to scheduling screening appointment

• Obtains informed consent per SOP and documents process

• Is prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs

• Ensures proper specimen collection, processing, shipment, and documentation in accordance with protocol

• Schedules study visits per study protocol and ensures all required visit procedures are complete prior to the subject leaving the office

• Reviews laboratory results and other test results for completeness and alert values. Ensures investigator reviews in a timely fashion

• Works with mentor to recognize adverse events (AEs) and Serious Adverse Events (SAEs)

• Promptly notifies Principal Investigator, sponsor, and site regulatory coordinator. Ensures safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol

• Schedules participants for necessary procedures and visits within appropriate windows as outlined in the protocol

• Integrates visits with existing schedule to maximize efficient workflow and participant turnaround

• As deemed appropriate, dispenses study medication per protocol and/or IVRS system and educates participant on proper administration and importance of compliance

• Monitors participant progress on study medication

Documentation:

• Records data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document participant progress.

• Follows ALCOAC - ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

• Corrects errors per SOP

• Accurately records study medication inventory, medication dispensation, and participant compliance. Ensures accurate maintenance of dispensing logs and IVRS confirmations is documented appropriately

• Maintains copies of all prescriptions written for study medication or procedures in participant chart

• Accurately transcribes data into CRFs, and input into electronic study-specific CRFs, if necessary

• Resolves data management queries and correct source data, as needed

• Records protocol exemptions and deviations as appropriate with sponsor, and completes Memo to File for participant chart and regulatory filing if necessary

• Ensures all sponsor correspondence (e-mails, telephone conversations) are uploaded to CTMS for regulatory filing

• Maintains copies of participant-specific correspondence in source charts

• Assists regulatory personnel with completion of continuing/final review reports to the IRB

• Performs other duties as assigned

The duties above are representative of the nature and level of work assigned and may include other duties as assigned/delegated.

REPORTS TO: Site Director & Study Principal Investigator

EDUCATION REQUIREMENT

• Registered Nurse (RN) diploma, Associate’s, or B.S. degree
• Valid Registered Nurse (RN) license in Florida
•  required/compact license
• IV Certification
•  2 years clinical research experience preferred
•  ACRP (CCRC)/SoCRA (CCRP) certification preferred
•  Bilingual (Spanish) preferred

KNOWLEDGE, SKILLS, ABILITIES

• Medical terminology

• Adept at performing clinical tasks including peripheral IV-line insertion

• Effective communication (both verbal and written)

• Ability to work in a fast-paced environment

• Detail oriented

• Ability to work collaboratively and cooperatively with others

• Acceptance of direction and constructive criticism

• Experience working with CTMS systems

• Familiar with Microsoft Word, Excel, and Outlook