Sr. Clinical Research Associate

Avania•,

8d•$130,000•Remote

About The Position

Avania is hiring a Senior Clinical Research Associate (Sr CRA) to join their ClinOps Team. This role involves performing clinical trial oversight to ensure the rights and well-being of human subjects are protected and that trial data is accurate, complete, and verifiable. The Sr CRA will partner closely with trial sites to ensure adherence to approved protocols, ISO14155 or ICH-GCP, and applicable regulatory requirements.

Requirements

Experience as a Clinical Research Associate
Knowledge of ICH-GCP and applicable regulatory requirements
Ability to interact with and guide study investigators and study coordinators
Proficiency in monitoring site activities and preparing for audits/inspections
Skill in conducting and writing visit reports
Ability to ensure data accuracy and verification
Experience with data review and query resolution
Familiarity with TMF reviews
Experience in developing and maintaining trackers
Ability to review and write informed consent forms
Experience reviewing protocols and investigator brochures
Ability to prepare clinical trial agreements
Skill in reviewing regulatory compliance for study documents and protocols

Nice To Haves

Experience as a Clinical Lead

Responsibilities

Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
Act as a 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).