Clinical Research Associate II

Avania•,

4d•$90,000 - $110,000

About The Position

Avania is expanding its US-based Clinical Operations team and is hiring a Clinical Research Associate II to establish, maintain, and support medical device clinical trials. Through clinical monitoring, the CRA II verifies that human subjects’ rights and well-being are protected and that trial data are accurate, complete, and verifiable against source documents. The role also ensures trials are conducted in accordance with approved protocols and amendments, ISO 14155 or ICH-GCP, and applicable regulatory requirements. The position involves monitoring investigational sites, with a focus on site initiation visits and travel to sites. The CRA II prepares and conducts monitoring visits, supports investigators and coordinators, verifies clinical data, resolves data issues, and tracks site action items. The role also contributes to study documentation, audit and inspection preparation, regulatory submissions and reporting, safety-event reporting, and clinical trial agreement preparation and negotiation.

Requirements

At least 2 years of prior CRA experience.
Prior experience must include MedTech or medical device and cardiovascular experience.

Responsibilities

Oversee clinical trial activities at investigational sites, focusing on site initiation visits; travel to investigational sites is required.
Conduct and write accurate pre-study, site initiation, routine monitoring, and close-out visit reports in accordance with SOPs and GCP.
Interact with and guide investigators and study coordinators in conducting trials according to study protocols.
Ensure investigational sites enter CRF data on time and verify consistency with patient clinical notes through source data/document verification.
Collaborate with analytical services to obtain a clean database, resolve queries, and conduct or participate in data reviews, identifying and communicating data trends or errors.
Monitor sites’ completion of action items between visits.
Prepare for audits and inspections and participate in internal TMF reviews.
Review and write informed consent forms.
Review protocols, investigator brochures, and CRFs in development for compliance with applicable regulations.
Prepare and assist with submissions to IRBs, ECs, CAs, and the FDA, and follow up until approval is obtained.
Prepare confidentiality agreements and complete clinical trial and investigator agreement templates.
Prepare annual trial progress reports for IRBs, ECs, CAs, and the FDA under supervision.
Assist with reporting serious adverse events to the sponsor, IRBs, ECs, CAs, the FDA, and investigators.
Participate in project and investigator meetings and write and publish meeting minutes.
Prepare clinical trial agreements and discuss or negotiate them between the site and sponsor.