Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team.
• Support audit readiness through scheduled department, internal, country, and investigator file reviews, documenting findings in appropriate systems.
• Coordinate, oversee, and complete assigned trial activities according to the task matrix.
• Ensure allocated tasks are completed on time, within budget, and to a high-quality standard; communicate risks to project leads.
• Provide system support for Activate and eTMF and keep system databases current.
• Process documents for the Client eTMF, perform eTMF reviews, distribute mass mailings and communications, and provide documents and reports to internal team members.
• Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings.
• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites.
• Support study-specific translation materials and translation quality control.
• Maintain knowledge of SOPs, client directives, and regulatory guidelines.
• Conduct on-site feasibility visits where applicable (Asia Pac only); occasional travel may be required.
• Support client/internal meeting scheduling and tracking of local regulatory documents.
• Support RBM activities and study documentation, training requirements, system access, and project activity plans.
• Transmit documents to the client and centralized IRB/IEC.
• Maintain vendor trackers.
• Support the start-up team with regulatory submissions.
• Work directly with sites to obtain site-selection documents.
• Assist with regulatory compliance review packages and coordinate internal departments to align site start-up activities with the site-activation critical path.
• Complete Site Interest Plans in CTMS where applicable and collect associated investigator/site documents.
• Document site communications, follow-ups, and survey responses in real time; review survey data for completeness and logic.
• Collaborate with teammates and clinical personnel to meet deadlines and address site issues and risks.
• Ensure effective site-contact and follow-up plans, escalating concerns or non-compliance to management.
• Act as a local expert on site capacity and experience, recommend additional sites, and support local site tiering.
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information.
• Contribute to global strategic feasibility processes and best practices.
• Train new personnel in processes and systems.
• Use local knowledge to identify and develop new sites.

• 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).
• 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.
• 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.
• 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 able to learn clinical trial database systems.
• Ability to successfully complete the organization's 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.