Nurse Practitioner - Clinical Research Sub-Investigator

Alcanza Clinical Research

9h

About The Position

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, SC, TX, VA, 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 Nurse Practitioner will be assigned as Sub-Investigator in research studies. As delegated by the Principal Investigator (PI), will perform physical and medical history assessments, and assist the PI with the medical management of subjects on a trial. The Sub Investigator may also function in a Clinical Research Coordinator role and coordinate daily clinical research activities according to the organization’s SOPs, GCP, and FDA/ICH guidelines. This position will be based at our clinic at Largo, Fl and will travel as needed to our satellite site in Clearwater, FL.

Requirements

• A Bachelor’s degree and a minimum of 2 years of clinical experience, or an equivalent combination of education and experience is required.
• Active license (in good standing) to practice as an advanced practice professional in the state of practice is required.
• BLS/ACLS certified required.
• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications
• Ability to type proficiently (40+ wpm);
• Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, reconstitution of IP, injections, and IV’s.
• 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.

Nice To Haves

• Experience in clinical research is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Responsibilities

• Under the direction of the Principal Investigator, performs the functions of Sub Investigator on research studies.
• Ensures IRB approved protocols are implemented and followed.
• Executes informed consent process and monitors patient status and safety; collects and organizes research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; educates patients and their families about treatments and possible side effects.
• Ensure and protect the patient’s welfare and rights as a research subject.
• May perform research protocol procedures which may include, but are not limited to: physical exams, injections, IVs, medical history review and assessment, and assessments of vital signs, laboratory results and adverse events.
• May mix and/or dispense investigational product and instruct subjects on usage and potential drug interactions;
• Participates at pre-study and site initiation visits, investigator meetings, and other customer facing meetings, as needed;
• Assist site management with support in change management and process improvement;
• Assist and participate with new staff training and mentoring;
• Assist and guide employees on study specific tasks;
• Utilize and ensure the appropriate equipment is on-site for Universal Precautions for themselves and others in and around areas that may contain potential biohazards
• Work with the Principal Investigator to maintain high quality and patient safety.
• Establish rapport with sponsor representatives and maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company;
• May perform role of Clinical Research Coordinator on studies as needed.
• Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines;
• 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;
• Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents;
• Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.;
• Maintain accountability of own ongoing professional growth and development;
• Performing all other duties as requested or assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level