Clinical Trial Coordinator

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

📋 Description

• Execute thorough trial and site administration under the supervision of the line manager.

• Prepare, organize, distribute, and archive clinical documentation.

• Assist in managing both clinical and non-clinical supplies.

• Maintain tracking and reporting tools effectively.

• Aid in achieving scheduled Site Ready dates.

• Assist in the preparation of submission packages for IRB/ERC and Health Authorities.

• Collaborate with COM, CRM, CRA, finance, and budgeting teams.

• Monitor essential documents and report safety findings.

• Gather and distribute study tools and documents.

• Update CTMS databases and trackers regularly.

• Oversee labeling requirements and manage translation change requests.

• Draft documents and correspondence as needed.

• Manage eTMF distribution, archiving, reconciliation, and quality control processes.

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

• Document the destruction of clinical supplies accurately.

• Prepare binders for Investigator trial files.

• Obtain necessary document translations.

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

• Obtain, track, and update study insurance certificates as required.

• Publish study results as mandated by local laws.

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

• Create, negotiate, approve, and maintain CTRAs and other contracts.

• Monitor contract negotiations and uphold contract templates with Legal.

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

• Ensure compliance with financial and procedural regulations.

• Track adherence and disclosures effectively.

• Obtain and process FCPA documentation as necessary.

• Organize meetings and prepare study memos, letters, and protocols.

• Provide support for local investigator meetings, including invitations, materials, venue selection, and vendor coordination.

⛳️ Requirements

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

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

• Practical knowledge of Good Documentation Practices.

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

• Excellent skills in MS Excel.

• Knowledge of ICH-GCP relevant to the role.

• Exceptional negotiation skills in financial areas for CTCs.

• Effective time management, organizational, interpersonal, and conflict-resolution skills.

• Strong communication abilities with external customers, sites, and investigators.

• Capability to set priorities and manage multiple tasks concurrently in a dynamic environment.

• Ability to work efficiently in a matrix multicultural setting.

• Skill in establishing and maintaining culturally sensitive working relationships.

• Ability to work autonomously.

• Proactive approach to problem-solving and proposing solutions.

• Positive and growth-oriented mindset.

• Preferred background includes job training in office management, administration, finance, or healthcare, or a Bachelor's Degree.

• Required skills: Clinical Document Management, Clinical Research, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Customer Focus, Microsoft Excel, Microsoft Office.

• Preferred skills: Clinical Trial Management Systems (CTMS), Clinical Trials, Communication.

• Only residents of the US and Puerto Rico are eligible.

• Visa sponsorship is not available.

🏝️ Benefits

• Annual bonus and long-term incentive, if applicable.

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

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

• Paid holidays.

• Vacation time.

• Compassionate and sick days.

• Remote work arrangement available.