Clinical Trial Coordinator – Monitoring

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

📋 Description

• Offer administrative support for trials and sites, encompassing data tracking and reporting.

• Prepare, organize, distribute, and store clinical documents.

• Assist in managing clinical and non-clinical supplies.

• Oversee the maintenance of clinical trial databases, CTMS, trackers, and reporting tools.

• Handle labeling requirements and coordinate requests for translation changes.

• Draft documents and correspondence while aiding in eTMF reconciliation.

• Implement the eTMF Quality Control Plan.

• Revise manuals and documents, including patient diaries and instructions.

• Document the proper disposal of clinical supplies.

• Assemble Investigator trial file binders and procure document translations.

• Assist in site evaluation, validation, start-up, and regulatory submissions.

• Monitor and update study insurance certificates.

• Publish study results as mandated by local legislation.

• Develop, manage, update, and finalize country and site budgets.

• Create, negotiate, approve, and maintain contracts such as CTRAs.

• Track contract negotiations and manage contract templates in collaboration with Legal.

• Calculate and facilitate payments to investigators, vendors, and grants.

• Ensure compliance with financial and regulatory procedures.

• Monitor adherence and disclosures.

• Obtain and manage FCPA documentation.

• Organize meetings and site visits, analyze study data, and compile reports.

• Support local investigator meetings, including managing invitations, materials, venue selection, and vendor assistance.

• Collaborate with Clinical Operations Managers, Clinical Research Managers, Clinical Research Associates, and finance and budgeting representatives.

⛳️ Requirements

• Fluent in local languages and proficient in business English, both verbal and written.

• Strong understanding of Global, Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Proficient IT skills, including MS Office and clinical IT applications.

• Advanced MS Excel capabilities.

• Knowledge of ICH-GCP relevant to the position.

• Exceptional negotiation skills for CTCs in the finance sector.

• Effective time management, organizational, interpersonal, and conflict resolution abilities.

• Strong communication skills with external clients, sites, and investigators.

• Ability to prioritize and manage multiple tasks in a dynamic environment.

• Capability to work efficiently in a matrix multicultural setting.

• Skill in establishing and maintaining culturally sensitive professional relationships.

• Customer-oriented mindset.

• Ability to operate independently.

• Proactive approach to problem-solving and proposing solutions.

• Positive and growth-oriented mindset.

• Completed training in office management, administration, finance, or healthcare, or possess a bachelor's degree.

• No visa sponsorship available.

• A valid driving license is not required.

🏝️ Benefits

• Annual bonus and potential long-term incentives.

• Medical, dental, and vision healthcare options.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave and sick days.

• Remote work opportunities.

• 10% travel requirement.

• No relocation necessary.