Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator II – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Operations Delivery Associate II, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities. Representing the organization in the global medical research community, you may develop collaborative relationships with investigators and site personnel. Additionally, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process.

What You’ll Do:
• Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. - Proactively communicates any risks to project leads and line manager as appropriate.
• Performs administrative tasks on assigned trials including but not limited to
• timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Reviews and tracks local regulatory documents.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials
• Assists with technical and administrative support for projects in collaboration with internal departments and team members.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
• May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
• May provide system support (i.e., Activate & eTMF).
• May transmit documents to client and centralized IRB/IEC.
• May attend Kick off Meeting and take notes when required.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
• May support start-up team in Regulatory submissions.
• Occasionally works directly with site(s) to obtain documents related to site selection.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalates concerns/non-compliance to management.

Education and Experience:
• High school diploma or equivalent; Bachelor's degree preferred
• Relevant experience in clinical trials or related field
• Previous experience that provides the knowledge, skills, and abilities to perform the job is the advantage
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Strong organizational and multitasking skills
• Proficiency in project-specific data/systems analysis

• Adaptability and ability to reprioritize workload
• Knowledge of Country Regulations, ICH Good Clinical Practices, and relevant SOPs
• Advanced English language skills; proficiency in local language (Czech) as needed
• Excellent computer skills, including MS Office and clinical trial database systems
• Strong interpersonal and communication skills
• Attention to detail and quality documentation
• Ability to work in a team or independently, as required
• Ability to work in a team environment or independently, under direction, as required

Working Conditions:
• Office or home office environment with standard office equipment