Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team.
• Support audit readiness by ensuring files are reviewed according to the organization's SOP and department guidance.
• Provide administrative support for site activation activities and aid in developing the site activation critical path.
• Develop and review site lists for feasibility activities and provide local input into site tiering.
• Coordinate, oversee, and complete assigned trial activities according to the task matrix.
• Perform department, internal, country, investigator, and eTMF file reviews and document findings.
• 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 databases current.
• Process documents to the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports.
• Analyze and reconcile study metrics and findings reports; assist with resolution of site documentation findings.
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies.
• Support study-specific translation materials and translation quality control.
• Conduct on-site feasibility visits where applicable in Asia Pacific.
• Support client/internal meeting scheduling and local regulatory document tracking.
• Support RBM activities and study documentation/system maintenance.
• Transmit documents to clients and centralized IRB/IEC.
• Maintain vendor trackers.
• Support regulatory submissions and site start-up activities.
• Work with sites to obtain site-selection documents and complete regulatory compliance review packages.
• Document site contacts, 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 site contact and follow-up plans are implemented and escalate concerns or non-compliance.
• Provide local expertise 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 feasibility processes and best practices.
• Train new personnel in processes and systems.
• Utilize local knowledge to identify and develop new sites.
• May act as a buddy during onboarding.

• 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.
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.
• 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.
• Occasional drives to site locations and potential occasional travel required.