Clinical Research Associate I

The Role

Assist with project management tasks within Clinical Development group
Collaborate with CRO(s) in the execution of clinical trials
Schedule meetings, set agendas, track action items and capture meeting minutes
Prepare, handle, distribute, file, and archive clinical documentation and reports
Monitor and QC the eTMF
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
Coordinate and manage logistical aspects of clinical trials, such as shipment of lab samples
Help monitor the progress of clinical trials, track timelines and ensure adherence to protocol and other study documentation
Assist in the preparation of regulatory submissions
May review and approve invoices, purchase orders and site payments
Identify and address potential risks to the project timeline, quality, or budget and escalate when necessary
Help manage relationships with external vendors, including CROs, laboratories, and other service providers
Help ensure all study materials are properly archived following the completion of a trial

Requirements

At least 3 years work experience as a Clinical Trial Assistant or CRA
Understanding of medical and pharmacological terminology
Knowledge of Good Clinical Practice (GCP) guidelines
Strong organizational and planning skills. Project management experience a plus
Good communication and interpersonal skills
Experience working with CROs
Experience maintaining eTMF preferred
Proficient with MS Project and/or Smartsheet preferred
Experience managing clinical lab samples a plus
Data review experience plus
BSc degree in life sciences or related field preferred

Benefits

Base salary range for this position at commencement of employment is expected to be $90,000 - $110,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value.

Pay

Commencement of employment

Schedule

Hybrid work schedule