Sr. Clinical Research Associate

Avania•,

1d•$140,000

About The Position

Avania is hiring two Senior Clinical Research Associates based in Pennsylvania, Maryland, and New York. The role is part of Avania’s Clinical Operations team, which establishes, maintains, and supports clinical trials. The Senior CRA provides clinical trial oversight to ensure that human subjects’ rights and well-being are protected and that reported trial data are accurate, complete, and verifiable from source documents. Working closely with trial sites, the Senior CRA helps ensure trials are conducted in accordance with approved protocols and amendments, ISO 14155 or ICH-GCP, and applicable regulatory requirements. The role may also act as a Clinical Lead overseeing clinical trial activities at investigational sites, which requires travel to those sites.

Responsibilities

Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
Serve as a member of the site start-up team for assigned projects.
Monitor sites’ completion of action items between visits and help prepare for audits and inspections.
Conduct and write accurate visit reports in accordance with SOPs and GCP, including SQV, SIV, IMV, and COV reports.
Ensure CRF data are entered timely and accurately and are verified.
Collaborate with analytical services to obtain a clean database, resolve queries, and conduct or participate in data reviews internally and with the sponsor; identify and communicate trends or erroneous data.
Participate in internal TMF reviews as needed.
Develop and maintain trackers, including visit report, site, recruitment, and enrollment trackers.
Review and write informed consent forms.
Review protocols, investigator brochures for compliance with applicable regulations, and CRFs in development.
Prepare clinical trial agreements and present them to the site and study sponsor.
Review regulatory compliance for study documents and protocols.
May act as a Clinical Lead overseeing clinical trial activities at investigational sites; this requires travel to investigational sites.