Clinical Research Nurse

Job description

Clinical Research Coordinator/Nurse

Department: Operations

Employment Type: Full Time

Location: Accel Research Sites - Decatur, GA

Reporting To: Benoit Tete

Description

Alcanza is a growing multi‑site, multi‑phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I‑IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

The Clinical Research Nurse works to ensure the execution of assigned studies, and performs clinical procedures, such as venipunctures, injections, prep or mixing of investigational study drugs and infusions, under the scope of the study protocol and in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Key Responsibilities

In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:

Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment

Patient consents

Patient follow‑up visits

Documenting in source clinic charts

Entering data in EDC and answers queries

Obtaining vital signs and ECGs

May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick‑up

Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.

Requesting and tracking medical record requests

Updating and maintaining logs, chart filings

Maintaining & ordering study specific supplies

Scheduling subjects for study visits and conducts appointment reminders

Building/updating source as needed

Conducting monitoring visits and resolves issues as needed in a timely manner

Ensuring study related reports and patient results are reviewed by investigator in a timely manner

Filing SAE/Deviation reports to Sponsor and IRB as needed

Documenting and reporting adverse events

Reporting non‑compliance to appropriate staff in timely manner

Maintaining positive and effective communication with clients and team members

Always practicing ALCOAC principles with all documentation

Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study

Complete all needed activities for study start‑up, including completing required training, uploading / printing certificates to file in ISF, etc.

Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed

May set up, train and maintain all technology needed for studies

May assist with study recruitment, patient enrollment, and tracking as needed

Maintaining confidentiality of patients, customers and company information

Performing all other duties as requested or assigned

Skills, Knowledge and Expertise

Minimum Qualifications: A Bachelor’s degree in Nursing (BSN) AND a minimum of 1 year of clinical experience, OR an equivalent combination of education and experience, is required. An active, unrestricted RN license, in state of work location, is required. BLS certification required. Bi‑lingual (English / Spanish) proficiency is a plus.

Required Skills:

Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm)

Proficiency with performing clinical procedures such as injections, vitals, EKGs, phlebotomy, infusions, etc. is required

Strong organizational skills and attention to detail

Well‑developed written and verbal communication skills

Well‑developed interpersonal and listening skills and the ability to work well independently as well as with co‑workers, subjects, managers and external customers

Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities

Must be professional, respectful of others, self‑motivated, and have a strong work ethic

Must possess a high degree of integrity and dependability

Ability to work under minimal supervision, identify problems and implement solutions

Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines

Benefits

Full‑time employees regularly scheduled to work at least 30 hours per week are benefits‑eligible, with coverage starting on the first day of the month following date of hire

Medical, dental, vision, life insurance, short and long‑term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered

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Worksite address

decatur, GA, 30089, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.