Trial Operation Lead-Clinical Research Scientist (CRS/Sr. CRS)
HAYS

Job Info

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The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking an Trial Operation Lead-Clinical Research Scientist (Sr. CRS and CRS) in Rockville, MD.

Role Description

As our corporate activities rapidly grow we are looking for a Sr. Clinical Research Scientist(s) and Clinical Research Scientist(s) (Sr. CRS and CRS) to help us complete our growing research staff.

• The Clinical Research Scientist will conduct collaborative research projects that are aligned with the strategic mission of the Research department. Lead the planning, execution and reporting of clinical trials on time, within budget and in compliance with company processes and regulatory requirements

Major Activities:
• Serve as support to Clinical Trial Leader for clinical trials and be responsible for assisting with the preparation of the protocol-related documents in IRB submission, eCRF development, data review, report and publications
• Responsibilities for the execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment and data consistency). Contribute to the preparation of clinical program documents (investigator brochure, IND annual report, HA briefing books and submissions).
• Part of the clinical trial team working with site staff throughout the trial execution. Coach and work collaboratively with team members. Actively contribute to multidisciplinary teams to support continuous improvement
• Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity
• Oversight of all activities listed and ensures all duties/documents/protocols to meet quality and integrity expectations, and delivers them in accordance with the sponsor expectations, trial protocol, GCP guidelines and applicable SOPs (local/US/international)
• Verifies that the rights and well-being of human subjects are protected, and that the reported trial data are accurate, complete and verifiable from source documents
• Coordinates and oversees the development of study protocols and amendments, and cooperates in the development of other essential materials for clinical studies, providing expertise and input throughout
• Obtain, review, and process necessary regulatory and administrative reports. Review essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
• Interact with other functional areas and key stakeholders, including Clinical Development and Clinical Operations; Regulatory Affairs, Data Management, Finance, Regulatory, Quality Assurance, Safety, and Human Resources as needed, to support clinical trial activities.
• Obtain and relay key study issues, status updates and other study information to the clinical trial team and management
• Review data to identify protocol deviations and risks to subject safety/data integrity and evaluate execution of study protocol at the site level.

Skills & Requirements

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information. #1125305

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