Senior Clinical Research Associate - Oncology
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry.
The Senior Clinical Research Associate - Oncology is a critical position within the Operations team and is assigned as a study lead to manage clinical trial studies. The Senior CRA will partner with a Project Manager to support activities on complex/larger trials and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Senior CRA will work to manage, oversee and may monitor/co-monitor clinical trial sites.
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
- Provide regular updates of study progression; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Participate in developing study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
- Maintains project timeline, conducts risk assessment/mitigation and contingency planning
- Create and conduct training sessions including investigator meetings and team trainings
- All work must adhere to ICH/GCP guidelines and comply with company SOP's
- Minimum of 5-7 years’ experience as a CRA, in the pharmaceutical/biotech or CRO industry
- BS in a life science discipline is preferred, minimum of an Associate’s Degree required. RN/BSN degrees are a plus.
- Must have 5 years of strong and recent experience monitoring Oncology clinical trials across multiple indications including blood cancers, solid tumors, and immuno-oncology studies
- Must have strong knowledge of ICH/GCP guidelines
- Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
- Travel varies due to COVID19 restrictions; combination of remote and onsite monitoring at this time. Typical average travel of 50% to study sites, to monitor, co-monitor, train, attend Investigator meetings or conferences.
?SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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