Sr Clinical Research Associate - North/South Carolina

*** We are seeking candidates from South/North Carolina***

Are you interested in a clinical research role that leverages your expertise in clinical trial site coordination? If so, this Clinical Research Associate role could be an ideal opportunity to explore.

As a Clinical Research Associate (CRA), you will manage/lead/be responsible for focusing on the coordination of all activities required to evaluate, initiate, monitor and close clinical trial sites in accordance with regulations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :

• Perform all site development, site set-up, site monitoring, and site close-out activities for specific clinical trial investigator sites in accordance with customer expectations, GSK operating
• Monitor compliance with study protocol, CFR, GCP/ICH and overall clinical objectives.
• Ensure clinical trial site training records are current and maintained as required.
• Verify adequacy of clinical data through comparison of case report forms to source documents.
• Perform CRF review, query generation and resolution against established data review guidelines
• Confirms appropriate management of investigational product by performing drug reconciliation and accountability and other related activities.
• Confirms all elements of lab assessment are conducted according to guidelines and standards.
• On-going review of site regulatory file for completeness and accuracy.
• Implement any new activities, instream, as defined by the study team to ensure compliance of protocol activities at site level
• Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance, subject safety and data quality.
• Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan.
• Assist with development of clinical trial specific documents such as Monitoring Plan, CRF Completion Guidelines, etc.
• Manage multiple timelines/deadlines to meet study milestones.
• Participate in Quality Plan activities, including management of activities to ensure quality outcomes.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in Life Science or professional degree in life science/ medical background/equivalent expertise.
• 5+ years of relevant experience working on clinical trials.
• Travel, including air travel is an essential function of the job - up to 80%. Travel external to assigned region is expected when other regions require support.
• Valid driver's license

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 2-3 years monitoring experience in clinical trials is preferable.
• Consistently displays excellence in communication skills of a top level CRA.
• CRA role requires understanding of medical and scientific concepts and language in order to effectively interpret protocol requirements, understand medical notes and effectively conduct monitoring activities.
• CRA role is complex and requires the ability to balance multiple competing priorities, stakeholders and timelines. Familiarity with the basic language and process of sponsored clinical research is required. In addition, knowledge of ICH-GCP and local regulations is critical for success in this role.
• Increased complexity of allocated studies, increased autonomy and requirement to contribute to process improvement requires significant level of expertise in core role.
• Exhibits ability to identify and interpret problems, recommend creative solutions, and influence appropriate changes.
• Demonstrates diligent and self-motivated approach to working in an off-site and independent working environment.
• Demonstrates above average ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Exhibits enhanced awareness of site dynamics and demonstrates ability to motivate, persuade, and educate site personnel.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*LI-GSK

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