Alcanza Clinical Research
Location
Charlottesville, Virginia
Acts as a Sub-Investigator to perform medical assessments, manage subject safety, and implement IRB-approved protocols. May also function as a Clinical Research Coordinator to manage daily research activities and regulatory documentation.
Requires a Bachelor's degree, an active advanced practice professional license, and BLS/ACLS certification. Minimum of 2 years clinical experience is required, with research experience highly preferred.
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, 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 or Physician Assistant 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.
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.
Skills, Knowledge and Expertise
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. 1+ years research experience is highly preferred. BLS/ACLS certified required. Bi-lingual (English / Spanish) proficiency is a plus.
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.
Sonographer - Full Time - Outpatient
LPN Floor Nurse 3pm-11pm & 11pm-7am
Personal Care Assistant (3-11pm & 11-7pm)
Non-licensed Clinical Research Coordinator (Varying Levels); Cancer Center
Non-licensed Clinical Research Coordinator (Varying Levels); Cancer Center
Patient Care Technician Med/Surg Oncology NIGHTS
Family Nurse Practitioner
Certified Residential Medication Aide/Personal Support Specialist (CRMA/PSS)
Domestic and Sexual Violence Counselor
State Tested Nursing Assistant (STNA)
Wellness LPN or LVN Nurse
Research Associate