Contract – Clinical Trial Assistant

CONTRACT - CLINICAL TRIAL ASSISTANT

Position Summary:

The Clinical Trial Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager (CTM) and Clinical Research Associate (CRA) in the management of clinical trials.

The CTA will be responsible for  tracking and document maintenance as applicable and supporting the oversight of vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals and budgets.

Essential Duties and Responsibilities: 

• Support one or more study execution team (SETs), including scheduling meetings, distributing agendas and meeting minutes

• Document outstanding action items with expected completion dates and responsible individual(s).  Follows-up on all SET action items
• Support SET risk management discussions, follow-up and documentation

• Track and maintain study information and report on study progress

• Track and provide IRB/IEC submission documentation and other supplementary documentation, as appropriate

• Obtain, review, process, and track study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
• Maintain and disseminate basic study tracking information including, but not limited to: visit reports, regulatory documents, site contact lists, team contact lists and vendor lists
• Support Essential Document Packet  (EDP) review and approval process
• Support Informed Consent Form (ICF) development, review and approval process

• Maintain and ensure the completeness of the Trial Master File (TMF) in accordance with SOP requirements
• Oversight of preparation, shipment and management of study supplies to sites
• Support preparation of materials for investigator meetings, workshops, and study manuals
• Lead development of study newsletters
• Support onboarding of new CTA team members
• Support process improvement initiatives 
• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs

Qualifications:

• Bachelor’s degree or equivalent or combination of relevant experience and training
• New to industry or up to 2 years of relevant industry experience  
• Effective communication skills
• Organizational skills and attention to detail
• Problem-solving skills
• Ability to efficiently perform multiple tasks and manage changing priorities
• Appropriate and timely escalation.​Demonstrate proficiency in Microsoft Word, PowerPoint and Excel
• Take direction well

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.