Description
Job Description:- 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 with study drug requests
- Assist in the management of clinical drug supplies, provide detailed reports to ensure sites have adequate clinical supplies to enroll patients without excessive waste of clinical products
- 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
- Assist in the organization and preparation for investigator, expert, IDMC and other meetings
- Assist in the tracking and administration of study budgets
- Assist in the preparation of progress updates
Requirements:
- Candidate will have a BA or BS in the sciences field.
- 3-4 years working in the industry is required, and at least one year of monitoring experience.
- Candidate will have strong written and verbal communication skills, and good organization skills with an attention to detail.
- The ability to work independently and collaboratively to provide high quality work while prioritizing task and meeting timelines.
- This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.
- Up to 25% travel may be required.
- Experience in the oncology therapeutic area is desirable.
To find out more about Real please visit www.realstaffing.com