- Assist and participate with new staff training and mentoring;
- 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.
- 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;
- Minimum Qualifications: A Bachelor's degree and a minimum of 2 years of clinical experience, or an equivalent combination of education and experience is required. Bi-lingual (English / Spanish) proficiency is required.
- Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, reconstitution of IP, injections, and IV's.
- 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.
- 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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Nurse Practitioner or Physician Assistant - Sugar Land, TX, United States - Alcanza Clinical Research
Description
Nurse Practitioner or Physician Assistant - Sub-Investigator (Must be Bi-lingual - English/Spanish)Nurse Practitioner or Physician Assistant - Sub-Investigator (Must be Bi-lingual - English/Spanish)
Operations
Employment Type:
Full Time
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, 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.
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.
collects and organizes research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; 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.
Assist site management with support in change management and process improvement;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.
