Clinical Trial Coordinator I

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Coordinate, manage, and finalize assigned trial activities in accordance with the task matrix.

• Conduct reviews of department, internal, country, and investigator files, documenting findings.

• Complete assigned tasks punctually, within budget, and to a high-quality standard.

• Proactively communicate project risks to project leads.

• Provide system support for Activate and eTMF while ensuring system databases are up to date.

• Process documents for Client (e)TMF, conduct (e)TMF reviews, distribute mass communications, and deliver documents and reports to internal teams.

• Analyze and reconcile study metrics and findings reports.

• Assist in resolving issues related to site documentation.

• Coordinate, compile, and distribute materials for the Investigator Site File, Pharmacy binder, and non-clinical study supplies.

• Assist with the preparation of study-specific translation materials and oversee translation quality control.

• Stay informed about SOPs, client directives, and regulatory guidelines.

• Support the scheduling of client and internal meetings.

• Review and monitor local regulatory documents.

• Assist with RBM activities and study-specific documentation and systems.

• Maintain study team lists, track training requirements, manage system access, and develop project activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers.

• Support regulatory submissions and activities related to site start-up.

• Collaborate directly with sites to gather site-selection documents.

• Assist in the preparation of regulatory compliance review packages.

• Complete Site Interest Plans in CTMS and gather relevant investigator and site personnel documents.

• Document communications with sites, follow-ups, and survey responses in real time.

• Review survey data for logical, complete, and relevant responses.

• Work collaboratively with team members and clinical personnel to meet deadlines and resolve site issues and risks.

• Maintain plans for site communication and follow-up, escalating concerns or instances of non-compliance as needed.

• Provide local expertise regarding site capacity and experience, recommending additional sites when necessary.

• Liaise with Global Investigator Services to address investigator queries and update account/contact information.

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel in processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

• Conduct on-site feasibility visits as applicable for Asia Pacific roles.

• May involve occasional driving to site locations and potential travel.

⛳️ Requirements

• High/Secondary school diploma or equivalent, along with relevant formal academic or vocational qualifications.

• Bachelor's degree is preferred.

• Prior experience of 0 to 1 year in a comparable role.

• An equivalent combination of relevant education, training, and/or directly related experience may be considered.

• Ability to work effectively both in a team and independently.

• Strong organizational skills and keen attention to detail.

• Capable of managing multiple tasks efficiently and effectively.

• Ability to analyze project-specific data and systems for accuracy and efficiency.

• Strong customer service orientation.

• Flexibility to reprioritize workload as necessary.

• Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

• Proficient English language and grammar skills, along with necessary local language proficiency.

• Proficient in MS Office Suite (Word, Excel, and PowerPoint).

• Ability to learn and master clinical trial database systems.

• Capability to complete the organization’s clinical training program.

• Effective oral and written communication skills.

• Strong judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Good negotiation skills.

• Ability to manage risk and perform appropriate risk escalation.

🏝️ Benefits

• Fully Remote work arrangement.

• Standard Monday–Friday work schedule.