Description
Primary responsibilities include but not limited to:- Contribute to the preparation of clinical protocols and amendments
- Performs clinical study or clinical site feasibility
- Assist in the activities associated with site start-up and management
- Support the administration of study budgets
- Coordinate the preparation and conduct Investigator Meetings
- Monitor progress of studies identifying delays and initiating corrective actions when necessary
- Track study related trends
- Support CRO relationships
- Monitor clinical sites for adherence to protocol, GCP and company SOPs
- Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
- Ensures adverse events are reported properly and follow-up in a timely manner
- Assist with operational activities associated with clinical studies. This may include communicating with sites, various CROs and vendors involved in the studies.
- Review regulatory documents, track in database and file in the clinical master files
- Contribute to the administrative details of the following materials for clinical trial conduct: informed consent forms, study instructions, case report forms (CRFs) clinical trial binders, subject status tracking etc.
- Assist in the management of clinical drug supplies
- Develop newsletters and other patient recruitment tools to help motivate investigators to achieve target enrollment
- Assist in the administrative preparation of protocols, amendments, investigational brochures, CRFs and other study-specific documents
- Travel up to 25% as required
Requirements:
- BA or BS in a science related field
- 3-4 years industry experience required; minimum 1 year monitoring experience
- Strong written and verbal communication skills
- Excellent organization skills with an attention to detail
- Ability to work independently and collaboratively to provide high quality work while prioritizing tasks and meeting timelines
- Experience in the oncology therapeutic area is highly desirable
To find out more about Real please visit www.realstaffing.com