Job Details

Clinical Trial Assistant Clinical Operations Excellence

The Opportunity:

• This is a unique opportunity for a Clinical Operations Professional. As the Clinical Trial Assistant Clinical Operations Excellence, you will be responsible for acting as an integral member of the Clinical Operations Excellence team and will be tasked to support the management of Clinical Operations processes and systems, in support of Clinical Operations and execution of clinical trials.

• Responsibilities include:

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Under guidance of manager, assist with the development, tracking and management of central Clinical Operations activities.

• Assist with development of standard processes (e.g., SOPs), tracking and documentation to facilitate efficient, high quality and compliant Clinical Operations processes across clinical studies.

• Assist in the central development, review, distribution, and follow up for clinical study documents and templates (e.g., study plans, training materials, study guides, manuals, etc.).

• Assist with Clinical Operations Systems activities, such as maintenance of information in the Learning Management System (LMS), Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), the ClinicalTrials.gov website, or in other tracking systems.

• May support the selection and set up activities of new or updated clinical systems (e.g., eTMF, CTMS).

• Support Clinical Operations during internal gap assessments and during inspections.

• Support inspection readiness.

• Track and prepare study-specific information utilizing databases, trackers, and other study tools.

• Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal Clinical Operations team meetings.

• May liaise with other cross functional teams or functional team members to track status and/or assist with central support of study support activities.

• May support central collection of information from service providers, such as computer system validation inventory information.

• May conduct other activities to support study teams, such as gathering investigator and site information to support study start-up, maintenance, and close-out activities, contacting investigator sites to provide study specific information, working with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.

• May serve as the point of contact for vendors for central processes or document/information collection.

• Support other clinical operations activities as appropriate.

Required Skills, Experience and Education:

• RN or Bachelor’s degree in biological sciences or health-related field desired.

• 1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations in an industry setting.

• Has knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guideline.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Excellent written and verbal communication and interpersonal skills.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Experience using and maintaining information in Clinical Operations e-systems (e.g., CTMS, eTMF) preferred.

• Excellent organizational skills and follow through.

• Attention to detail.

• Travel may be required (~10%).

Preferred Skills:

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience preferred.