Clinical Research Associate II

Avania•,

4d•$90,000 - $110,000

About The Position

Avania is hiring Clinical Research Associate II (CRA II) employees based in Pennsylvania, Maryland, or New York. The role establishes, maintains, and supports clinical trials. Through monitoring, the CRA II verifies that the rights and well-being of human subjects are protected and that reported trial data are accurate, complete, and verifiable from source documents. The CRA II also ensures trials are conducted according to approved protocols and amendments, ISO 14155 or ICH-GCP, and applicable regulatory requirements. The position requires travel to investigational sites, particularly for site initiation visits. The listed salary range is $90,000–$110,000, plus an annual performance-related bonus and benefits.

Requirements

At least 2 years of prior CRA experience.

Responsibilities

Oversee clinical trial activities at investigational sites, with a focus on site initiation visits; travel to investigational sites as required.
Conduct and write accurate visit reports in accordance with SOPs and GCP for pre-study, site initiation, routine monitoring, and close-out visits.
Interact with and guide study investigators and study coordinators in conducting trials according to study protocols.
Ensure sites enter CRF data in a timely manner and verify consistency with patient clinical notes through source data/document verification (SDV).
Collaborate with analytical services to obtain a clean database, resolve queries, participate in data reviews, and identify and communicate trends or erroneous data.
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 submissions to IRBs/ECs and CAs/FDA, assist with submission administration, and follow up until approval is obtained.
Prepare confidentiality agreements and clinical trial/investigator agreement templates; prepare clinical trial agreements and discuss or negotiate them between sites and the sponsor.
Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision.
Assist with reporting Serious Adverse Events to the sponsor, IRBs/ECs, CAs/FDA, and investigators.
Participate in project and investigator meetings and write and publish minutes.