Job Title: Clinical Research Associate I
Location: Remote
Reports to: Head of Clinical Operations
The Role:We're looking for a passionate and curious, CRA 1 to join our team. If you're excited by new challenges, to work as the lone CRA in a small clinical development group, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.
As the CRA 1 at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team.
What You'll Do:- 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
Who You Are:- 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
The 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.
