Note: The job is a remote job and is open to candidates in USA. Just-Evotec is a forward-thinking company that values curiosity and innovation. They are seeking a Clinical Research Associate I to join their small clinical development group, where the individual will drive impactful projects and collaborate with the team on clinical trials.
Responsibilities
- 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
Skills
- 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
- Proficient with MS Project and/or Smartsheet
- Experience managing clinical lab samples
- Data review experience
- BSc degree in life sciences or related field
Benefits
- Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
- Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life, with hybrid work schedules in many of our various locations.
- Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
- Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
Company Overview
Company H1B Sponsorship