In-House CRA II / Senior In-House CRA
You’ll be accountable for:
- Managing Study Master Files
- Collecting contracts, requesting/collecting relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator/site documentation, reviewing and approving documents in applicable database
- Processing core study documents (upload, assign attributes, file, review and approval in eTMF)
- Ensuring successful study start-up (e.g site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements, as needed
You’ll be responsible for:
- Monitoring data remotely, as needed, with a focus on data integrity and patient safety, in accordance with specific country regulations
- Working with the line manager and CM to ensure that visit metrics are maintained as required.
- Gauging the quality of clinical deliverables and addressing quality issues with team members
- Managing query resolution with study sites and Premier Research data management operations.
- Maintaining the project tracking system of subjects and site information
- Maintaining contact with investigator sites via telephone calls
- Ensuring adherence to study timelines and budgets.
- Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
- Perform budget negotiations and/or interact with internal legal team , as needed
You'll need this to be considered:
- Bachelor’s Degree required
- 5+ years of relevant clinical research experience
- Background in human clinical study experience required
- Experience working with CTMS and eTMF systems
- Experience with Informed Consent review
- Experience working with Institutional Review Board(s)
- Must have experience with inspection readiness and NDA submission
- Must have oncology experience