Senior Field Clinical Specialist: Trials Oversight

Avania LLC.; United States; On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Annual performance-related bonus

Comprehensive benefits package

Job summary

Hirebridge is looking for a Senior Clinical Research Associate to join their team. In this role, you will oversee clinical trial activities to ensure compliance with protocols and regulatory requirements. You will collaborate closely with study investigators and coordinators, ensuring accurate data and oversight during the trials.

This position offers a competitive salary of up to $130,000, plus additional performance bonuses and benefits. Ideal candidates will have a strong background in clinical research and trial management.

Qualifications

• Experience in clinical trials, especially in oversight roles.
• Strong understanding of regulatory requirements and compliance.
• Exceptional organizational skills and attention to detail.

Responsibilities

• Guide study investigators and coordinators in clinical trial execution.
• Monitor site's action items and prepare for audits and inspections.
• Ensure timely and accurate data entry on CRFs.
• Develop and maintain trackers for trial activities.

Skills

Clinical trial oversight

Knowledge of ISO14155 and ICH-GCP

Data analysis and verification

Strong communication skills

Education

Bachelor's degree in a relevant field

Tools

Clinical trial management software

Job description

Avania is hiring SeniorClinical Research Associates (Sr CRAs) / Field Clinical Specialist (FCS)

Salary Range up to $130,000 +/- DOE with additional 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).