Our client is looking for Sr. CRA / Clinical Trial lead with 3-5+ years of monitoring and at least 2 years of clinical lead experience. This professional will support the VP in overseeing and implementing necessary monitoring-related project activities and will ensure that assigned clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Primary responsibilities (Not limited to):
- Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) / Good Clinical Practice (GCP) guidelines, and company / sponsor SOPs.
- Critically evaluates monitoring effectiveness. Collaborates planning techniques to ensure efficient monitoring and corrective plan implementation when necessary.
- Maintains awareness of key study performance indicators for all study sites. Updates study and subject status information.
- Anticipates and identifies potential issues. Implements corrective action. Provides guidance to resolve complex issues.
- Collaborates with clinical study team to successfully carry out study objectives.
- Oversees and manages multiple ongoing protocols.
- Assists with review, escalation and follow up of patient issues including safety, registration, and visits.
- Assists with reviewing country and site specific ICFs.
- Oversees routine reviews of study eTMF and portals for accuracy and completeness. Ensures proper documentation / filing practices are being maintained.
- Clinical Research Associate
- Clinical Trial Lead
- Oncology (min 2 years)
- Phases I,II,III and expanded study experience
- Experience in management of vendors and global sites
Duration: 6 Months +
Start Date: 12/5
Education: BS/BA degree or equivalent (background in life sciences preferred)
Remote: Sr. CRA / Clinical Trial Lead (232131)