Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Clinical Research Associate position could be an exciting 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. We are looking for candidates in Charlotte, NC and Atlanta, GA.
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.
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.
Consistently displays excellence in communication skills of a top level CRA.
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.
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
If you have the following characteristics, it would be a plus:
Two years monitoring experience in clinical trials is preferable.
Our values and expectations are at the heart of everything we do and form an important part of our culture. These includePatient 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.
GSKBiopharm_Development (for R&D)
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.