What are the responsibilities and job description for the Non Clinical Site Support Operative position at Apsida Life Science?
Apsida Life Sciences has partnered with a large healthcare company looking for a Non-Clinical Site Support Operative
Responsibilities:
- Assist the PI and site team with tasks according to study protocols, after proper training and delegation.
- Support the Clinical Research Associate (CRA) by attending site visits and addressing queries.
- Track trial progress by updating Clinical Trial Management systems.
- Process, package, and ship biological samples to the central lab.
- Adhere to MRN processes and protocol training during visits.
- Maintain professional standards in line with FDA, ICH-GCP, Research Governance, and US regulations.
- Provide quality subject care per study protocol and US requirements.
- Ensure accurate documentation of subject information and communicate updates to relevant team members.
- Collaborate with MRN and site teams to meet service requirements for subjects.
- Manage supplies for scheduled visits.
- Maintain flexible working hours to accommodate research visit needs.
- Submit Site Support Operative Report Forms (SSORF) and expenses to MRN as needed.
Specific Study Tasks:
- Assist with safety reporting (SAE, SUSARs, line listings).
- Support study visits and assessments:
- Aid in planning and conducting visits.
- Assist in informed consent process.
- Perform disease assessments, vital signs, physical measurements, ECGs.
- Monitor for AEs and SAEs.
- Administer patient-reported outcomes and train patients on urine collection.
- Assist with source documentation and IP dispensing.
- Assist Study Coordinator with tasks:
- Book patient appointments, dispatch materials, perform IRT transactions.
- Update site study logs, enter data into EDC, resolve queries.
- Collect and ship biological samples, manage lab kits.
- Maintain equipment calibration records, follow up on lab results.
- Assist with AE reporting and filing Investigator Site Files.
Skills Requirements:
- Medical professional (nurse, phlebotomist, etc.) with registration to work in SC.
- Clinical research experience is a plus.
- Skilled and confident in blood collection.
- Supportive and flexible approach to patient care during trials.
- Strong communication and computer skills (MS Office).
- Flexibility regarding work hours within normal working week.
- Mandatory face-to-face training.