Senior Clinical Trial Assistant

Rockville, Maryland
Mar 25, 2021
Apr 10, 2021
Jobseeker Type
Organization Type
Are you looking for an opportunity to share your knowledge of how evidence generation and research studies are conducted, reported, and published? If so, this is the role for you.

As a Senior Clinical Trial Assistant you will be responsible for supporting the end to end delivery of Evidence Generation for marketed products across the classic and established portfolio. You will also work with country study teams to manage budgets, resourcing, and be responsible for tracking funded studies.

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

Regulatory and Ethics
  • Assist timely regulatory submissions.
  • Liaise with investigators to ensure timeous application to and satisfactory approval of clinical trials by the appropriate ethics committees.
  • Assist with collation of clinical trial progress reports for regional and national ethics committees and regulatory authorities, as well as for GSK internal use.
  • Tracks any changes in local regulations and drives local implementation and communication towards management on this and proposes actions

Support to Clinical Trials often involved in more complex studies
  • Maintain eTrack and Veeva Vault
  • Maintain TMF(Veeva throughout the course of the study according to departmental SOPs and ICH- GCP.
  • Manages the collection, submission and review of important trial related documents
  • Assist in ordering and shipping of clinical trial materials to sites
  • Support translations of study related documents where applicable
  • Manage user access for clinical trial related systems (e.g Inform, SBIR, Team sites)
  • Tracks and maintain safety reports reported in compliance with regulatory authorities, GSK SOPs and ICH-GCP.
  • Maintain and disseminate study contact lists and trackers
  • Assist as needed with site selection activities
  • Maintain study sharing databases and accesses
  • Support the Organization of study specific meetings
  • Provide assistance to CRA/LDL during the course of the trial.
  • Maintain working relationship with investigators and staff.

Process Improvement
  • Acts as Subject Matter Expert - might be involved as such as well in above country initiatives
  • Maintains and revises current processes
  • Pro-actively proposes process improvement, SOPs, policies, guidelines, etc
  • Focus on continuous improvement of clinical trial processes.
  • Participate in peer review processes
  • Identify as expert to collaborate in the different Process improvement initiatives (e.g Champion role: e-TMF, e-Track Cold Chain, etc)

Mai nta in G SK 's Pr ofess ion al Qual it y and Res earch Va lues
  • Complies with both local and corporate SOPs, ICH-GCP Guidelines and other statutory regulations to ensure quality standards are achieved.
  • Complies with Regulatory and IEC/IRB requirements.
  • Always being proactive in issue detection, escalation and resolution
  • Assist in setting up new employees on relevant systems and completing documentation
  • Assist in Completion and tracking of ABAC related activities

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Associates Degree (in a life science field)
  • 5+ years of experience in similar roles
  • Computer literate -Word, Excel, PowerPoint, Outlook, SAP
  • Knowledge of ICH GCP

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • G raduate/Bachelor degree (in a life science field)
  • Relevant working experience in pharmaceutical / scientific environment.
  • Finance experience
  • Knowledge/experience in Veeva Clinical Vault
  • Previous experience in feasibility and clinical site selection as well as document management in study start up.
  • Excellent knowledge of written and spoken English
  • Excellent organization skills, ability to prioritize
  • Flexible and proactive working attitude
  • Good communication skills
  • Professional attitude with good customer focus
  • Effective team member with good interpersonal skills
  • Attention to detail
  • Demonstrated ability to organize and facilitate/conduct the events
  • Ability to understand and follow policies and procedures
  • Strong administrative skills

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

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