Clinical Research Coordinator supporting study activities at Hawthorne Health with onsite and remote work. Responsible for clinical trial activities, patient interaction, and data management.
About the role
- Clinical Trial Manager overseeing clinical studies with a focus on Atopic Dermatitis. Ensuring compliance with ICH GCP and delivering results within contractual timelines.
Responsibilities
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
- Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
- Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics.
- Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met.
- Coordinate all start-up activities and ensure that timely ethics committee and regulatory submissions are addressed.
- Review and follow up on all questions raised by the ethics committees.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Therapeutic experience in Atopic Dermatitis is essential to be considered for the opportunity.
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
- Good planning and organizational skills to enable effective prioritization of workload.
- Familiarity with the practices, processes, and requirements of clinical monitoring.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
- Capable of evaluating workload against project budget and adjusting resources accordingly.
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
Benefits
- Competitive salary
- Health insurance
- Professional development opportunities
- Flexible working hours
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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