FSP Clinical Trial Coordinator

Job Description

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation. As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. 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 and aid in the development of the critical path for site activation within assigned projects to support rapid site activations.

What You'll Do

• Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, 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.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• 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 and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• May support scheduling of client and/or internal meetings.
• May review and track local regulatory documents.
• May support RBM activities.
• Transmits documents to client and centralized IRB/IEC.
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned.
• May complete the 'Site Interest Plan' in CTMS and collection and delivery of associated documents from investigators and site personnel.
• Documents in real time all communication, attempts and follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects.
• Ensures an efficient, effective plan is in place for site contact and follow up.
• May act as the local expert regarding site capacity and experience.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain 'accounts and contact' information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.
• Trains new personnel in processes and systems.
• Utilizes local knowledge to contribute to the identification and development of new sites.

Education and Experience Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

Knowledge, Skills and Abilities

• Ability to work in a team or independently as required.
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
• Strong customer focus.
• Flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
• Good English language and grammar skills and proficient local language skills as needed.
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
• Ability to successfully complete the organizations clinical training program.
• Self-motivated, positive attitude and good interpersonal skills.
• Effective oral and written communication skills.
• Essential judgment and decision-making skills.
• Capable of accurately following project work instructions.
• Good negotiation skills.
• Independent thinker.
• Ability to manage risk and perform risk escalation appropriately.

Working Conditions and Environment

Work is performed in an office/laboratory/clinical and/or home office environment with exposure to electrical office equipment. Occasional drives to site locations. Potential occasional travel required.