Sr. Clinical Research Associate

Avania LLC.; New York (NY); On-site; USD 126,000 - 154,000; Full time

Benefits offered by this job

Annual bonus

Benefits

Job summary

Avania is seeking two Senior Clinical Research Associates (Sr CRA) based in PA, MD, and New York to oversee clinical trials in adherence to approved protocols and regulations. The Sr CRA will monitor site activities, ensure data integrity, and support audits while collaborating with sponsors and investigators.

The role may involve travel to investigational sites; ISO14155 and ICH-GCP experience will be valuable.

Responsibilities

• Interact with investigators and study coordinators in conducting clinical trials in accordance with study protocols. Member of a site Start-up Team for assigned projects.
• Monitor site’s 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 (SQV, SIV, IMV, COV)
• Ensure data entered on the CRFs is timely, accurate and verified. Collaborate with analytical services to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
• Participate in internal TMF reviews, as needed.
• Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.
• Review and write informed consent forms. Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development. Prepare clinical trial agreements and present to 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 (will require travel to investigational sites).

Job description

Avania is hiring 2 x SeniorClinical Research Associate (Sr CRA) based in either PA, MD and New York

Salary Range up to $140,000 + Annual Performance related bonus + Benefits

Avania’s ClinOps Team establishes, maintains and supports clinical trials; as a key member of the team, our Sr CRA performs clinical trial oversight for the trials, verifying that the rights and well-being of human subjects are protected, and that reported trial data are accurate, complete, and verifiable (from source documents).

Partnering closely with our Trial sites, Avania's Sr CRA ensures that the conduct of the trial follows approved protocols/amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Our Senior CRA role includes the following key activities -

• Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols. Member of a site Start-up Team for assigned projects.
• Monitor site’s 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 (SQV, SIV, IMV, COV)
• Ensure data entered on the CRFs is timely, accurate and verified. Collaborate with analytical services to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
• Participate in internal TMF reviews, as needed.
• Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.
• Review and write informed consent forms. Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development. Prepare clinical trial agreements and present to 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 (will require travel to investigational sites).