Clinical Trials Administrator II

New Haven, CT

Contract

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OVERVIEW

The role of the Clinical Trials Administrator II is to generate and maintain study essential documents checklist, IP release documentation and proactively ensure study document submission to the eTMF throughout the study’s life cycle, deliver CRA training at kick-off meeting on business technologies/applications that are operational in a study and Coordinate study team training in the investigator portal; monitor site/CRA user access and track training compliance during the course of a study especially around staff changes or protocol changes.  The role is located in New Haven, CT. The Clinical Trials Administrator II is encouraged to have a solid understanding of software capabilities and business applications and good oral and written communication and interpersonal skills. 

RESPONSIBILITIES

  • Customize/update any portfolio level plans or process flows to the study/site level in collaboration with the CPLs and the CRO teams, as appropriate such TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release documentation collection plan, etc.
  • Serve as a system expert for the implementation of any business technologies that are operational in a study/franchise throughout the study’s life cycle (EDC, Legal suite, Inv. Portal, eTMF, infosario, etc.)
  • Generate and maintain study essential documents checklist, IP release documentation and proactively ensure study document submission to the eTMF throughout the study’s life cycle
  • Coordinate study team training in the investigator portal; monitor site/CRA user access and track training compliance during the course of a study especially around staff changes or protocol changes
  • Deliver CRA training at KOM on business technologies/applications that are operational in a study
  • Responsible for ensuring registration of a protocol in ClinTrials.gov and monitor its update throughout a study’s life cycle for compliance with the regulations and SOP
  • Participate in sponsor operational team meetings with the CRO, Data Management, Regulatory Affairs, CQA and Clinical Supplies and document escalations and actions around training, TMF, IP release Clinical Trial Registry documentation
  • Participate as a SME in the implementation of various Clinical Operations initiatives in conjunction with the CoE as required. Ensure consistent implementation of best practices across all studies in a franchise


EXPERIENCE

  • 4 years clinical research experience in the pharmaceutical industry
  • Solid understanding of software capabilities and business applications
  • Good oral and written communication and interpersonal skills
  • Knowledge of clinical trial practice and processes with ability to present systems/application requirements for business system design
  • Proven ability to manage and prioritize multiple tasks remaining focused on personal objectives and working effectively in a multi-disciplinary team or independently when required
  • Mentor and lead junior staff to share their vision and support them to reach a common goal
  • Work with CROs and vendors to drive accountability

EDUCATION

  • CCRP certification.  Bachelor’s degree is preferred.

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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