Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study.
Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.
Create consent and assent templates specific to the needs of the planned study.
Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent.
Train site staff on protocol requirements, source documentation, and case report form completion.
Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent/assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments.
Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
Coordinate project meetings.
Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc.
Participates in team meetings and tracks action items.
Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
Performs other duties as required.

B.S. or B.A. and/or an equivalent combination of education or experience.
CRA certification
Minimum of 3 years of experience.
Available to travel on short notice and independently manage travel schedules.
Direct experience in participating in the execution of clinical research studies.
Must have analytical skill, be detail oriented and have good interpersonal skills.
Knowledge of agency guidelines and requirements.

Clinical Research Associate

Key skills