We are seeking a Senior CRA (Remote Contract with VERY MINIMAL TRAVEL – Less than 10%) for a successful and stable Molecular Diagnostics Sponsor. This Senior CRA to support Oncology Diagnostics studies. You will perform site start-up activities and visits (such as SQVs and SIVs), Site Monitoring Visits/IMVs (mostly remote visits), and related pre- and post-monitoring activities. This Senior CRA should be able to communicate with sites, deliver presentations, provide updates, and provide ongoing site management and support. Also: Support eTMF management, document filing, CTMS updates, EDC query follow-up, and site data cleaning activities.
REQUIREMENTS:
4 years of Regional/Site Monitoring experience. Experience working on oncology trials Tech Savvy, ability to pick up new systems quickly, experience working in google workplace a plus. Recent Study Start-Up, SIV visit experience a hard requirement Remote Monitoring experience a plusPRIMARY RESPONSIBILITIES:
- Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
- Develop study-related documents with minimal Clinical Trial Manager guidance including protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
- Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
- Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC
- Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements
- Oversees clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
- Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
- Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies
- Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies
