Sub-Investigator - 230506
2 months ago
Malden, United States
Medix™
Full time
Overview:
We are seeking a highly skilled Sub-Investigator (Sub-I) to support two concurrent flu vaccine trials at our site in Malden, MA. The successful candidate will play a crucial role in the execution of these industry-sponsored trials, ensuring adherence to study protocols and contributing to the advancement of vaccine research.
Key Responsibilities:
- Serve as the Sub-Investigator for vaccine trials, providing clinical expertise and ensuring adherence to trial protocols and regulatory requirements.
- Conduct study visits and evaluations, including physical assessments, when patients come in for scheduled appointments.
- Work closely with the Principal Investigator and study team to coordinate trial activities, including patient recruitment and follow-up.
- Manage remote responsibilities such as data review, documentation, and communication with the study team and sponsor.
- Ensure all aspects of the trials are conducted according to the protocol, FDA regulations, and Good Clinical Practice (GCP) guidelines.
Qualifications:
- Nurse Practitioner (NP) or Physician Assistant (PA) with strong clinical trial experience.
- Ideal candidates will have previous experience as a Sub-Investigator on industry-sponsored vaccine trials. Candidates with at least 2+ years of vaccine trial experience preferred.
- Demonstrated expertise in managing clinical trials, excellent organizational skills, and a strong understanding of vaccine research protocols.
- Ability to commit to a part-time schedule with the option for increased hours as needed.
- Willingness to travel to the site for patient visits during the enrollment period, with the ability to perform other tasks remotely.