GSK

Senior Clinical Research Associate

Employer
GSK
Location
Miami, Florida; Jacksonville, Florida
Salary
Competitive
Posted
February 16 2021
Ref
280046
Organization Type
Pharma
Job Description

** We are seeking candidates from Florida - Miami, Orlando, Tampa Or Jacksonville

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 standards, and good clinical practices.
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Supports and implements Risk Based Monitoring as directed.
  • Evaluates the Risk Signals of KRIs along with existing knowledge and experience of investigator sites to support appropriate monitoring intervention, frequency of intervention and areas to focus on during intervention
  • Participates in study team activities, such as PM lead, reviewer for study documents, user acceptance testing, and all activities requiring the input of CRAs.
  • Contributes to Investigator meetings by presenting topics or managing interactive sessions with investigator site staff.
  • Reports out on audit findings, and corrective actions as lessons learned.
  • Assist in developing the field monitoring organization characterized by process standardization, best practice sharing, and continuous improvement.
  • Function as the primary site contact between the site staff (i.e., Principal Investigator, Study Coordinator) and GSK. Cultivates and maintains strong working relationships and communication with investigators and GSK staff.
  • Assume a greater leadership role in the development and implementation of efficient and effective approaches to study site management (e.g. training co-workers and/or contract monitors; coaching/mentoring monitoring colleagues and study staff, as appropriate;
  • Provides training, delegated by the Monitoring Manager, for new monitoring personnel and contributes to their performance appraisals, as appropriate.
  • Acts as a resource for other monitoring personnel regarding study-specific knowledge, as well as monitoring issues.
  • Assist with training of all site personnel through established formal channels when deemed essential
  • Takes a leadership role within monitoring organization through assisting with clinical projects, as appropriate.
  • Represents US Monitoring / Global Clinical Operations on internal and external process improvement teams. Takes leadership role when participating in process teams on behalf of the Monitoring organization.
  • Independently completes special projects as assigned by Monitoring management.
  • Performs the following routine clinical trial site monitoring functions:
    • 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.
  • A minimum of 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

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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