Clinical Trial Coordinator - Monitoring (Remote)

MSD•Rahway, NJ

1d•Remote

About The Position

Under the oversight of the line manager, the Clinical Trial Coordinator-Monitoring (CTC-M) is responsible for comprehensive trial and site administration, including preparing, collating, distributing, and archiving clinical documents. The role supports clinical and non-clinical supply management and maintains tracking and reporting tools to help meet planned Site Ready dates, including assisting with IRB/ERC and Health Authority submission packages. The CTC-M collaborates locally with Clinical Operations Managers, Clinical Research Managers, Clinical Research Associates, and finance and budgeting representatives to manage Clinical Trial Research Agreements and payments. The position also supports regulatory and site start-up activities, document management, budgeting and contracting, payments, and investigator meeting planning. It requires effective coordination with country teams and other internal functions, along with communication with investigators, sites, vendors, and regulatory stakeholders. This is a remote role with 10% travel. The stated salary range is $68,000–$107,000. The successful candidate may be eligible for an annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, and other insurance benefits for employees and family, retirement benefits including a 401(k), paid holidays, vacation, and compassionate and sick days.

Requirements

Fluent in local languages and business-proficient in English, both verbal and written.
Excellent communication skills, including effective communication with external customers such as sites and investigators.
Good understanding of global and country or regional clinical research guidelines and ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Good IT skills, including Microsoft Office and clinical IT applications, and ability to adapt to new IT applications.
Strong Microsoft Excel skills.
ICH-GCP knowledge appropriate to the role.
Excellent negotiation skills for finance-related CTC responsibilities.
Effective time management, organizational, interpersonal, and conflict-management skills.
High sense of accountability and urgency.
Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Ability to work effectively in a matrixed, multicultural environment and establish and maintain culturally sensitive working relationships.
Commitment to customer focus, internally and externally.
Ability to work independently.
Proactive approach to solving problems and proposing solutions; positive and growth mindset.
Completed job training in office management, administration, finance, or healthcare, or a bachelor's degree.

Nice To Haves

Preferred job training in office management, administration, finance, or healthcare.

Responsibilities

Provide data tracking and reporting assistance to teams within Site Management & Monitoring.
Collate and distribute study tools and documents.
Update clinical trial management systems (CTMS) and trackers.
Support clinical and non-clinical supply management with other country roles.
Manage labeling requirements and coordinate or sign translation change requests, where applicable.
Prepare documents and correspondence; collate, distribute or ship, and archive clinical documents, including eTMF materials.
Assist with eTMF reconciliation and execute the eTMF Quality Control Plan.
Update manuals and documents, such as patient diaries and instructions.
Document proper destruction of clinical supplies.
Prepare investigator trial file binders and obtain document translations.
Provide and collect forms and lists for site evaluation or validation, site start-up, and submissions in a timely manner, in collaboration with country roles.
Obtain, track, and update study insurance certificates.
Support preparation of IRB/ERC submission packages and submissions to regulatory agencies.
Publish study results for Global Clinical Trial Operations and Regulatory Affairs when required by local legislation.
Collaborate with finance and budgeting representatives to develop, control, update, and close out country and site budgets, including split-site budgets.
Develop, negotiate, approve, and maintain contracts such as CTRAs; track and report contract negotiations; and maintain contract templates with the Legal Department.
Calculate and execute payments to investigators, vendors, and grants.
Ensure adherence to financial and compliance procedures; monitor and track adherence and disclosures; maintain tracking tools; and obtain and process FCPA documentation in a timely manner.
Coordinate meetings and site visits, and track, manage, and analyze study data and prepare reports as needed.
Support local investigator meetings by managing invitations and materials, selecting venues, and supporting vendors where applicable.