Clinical Trial Coordinator (CTC)

Merck; Rahway (NJ); Remote; USD 68,000 - 107,000; Full time

Benefits offered by this job

Remote work

Annual bonus

401(k) and benefits

Job summary

Regulatory Jobs in the United States is seeking a Clinical Trial Coordinator to support trial and site administration, document management, and regulatory submissions. The role involves maintaining CTMS, coordinating CTRAs, and assisting with IRB/ERC submissions while collaborating with COM/CRM/CRA and finance teams.

You will handle budgeting, vendor payments, meeting planning, and ensure adherence to ICH-GCP guidelines. This remote-friendly position includes up to 10% travel within the U.S.

Qualifications

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.
• Fluent English with strong written and verbal communication.
• Experience in clinical trial operations and regulatory processes is a plus.

Responsibilities

• Trial and site administration including tracking essential documents.
• Document management: collate, distribute, archive eTMF and study tools.
• CTA: update CTMS, trackers, and support CTRAs with budgets.
• Regulatory & site start-up: assist with submissions to IRB/ERC and health authorities.
• Budgeting, contracts, and payments: manage country/site budgets and payments.

Skills

Clinical document management

Clinical research

Clinical trial documentation

ICH-GCP knowledge

Negotiation skills (finance)

Time management

Communication skills

Independent worker

Education

Bachelor’s Degree

Tools

CTMS

Clinical Trials

Microsoft Excel

Microsoft Office

Job description

Job Description

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Trial and site administration

• Track (e.g. essential documents) and report (e.g. Safety Reports).
• Ensure collation and distribution of study tools and documents.
• Update clinical trial databases (CTMS) and trackers.
• Clinical supply & non-clinical supply management, in collaboration with other country roles.
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable).

Document management

• Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF.
• Assist with eTMF reconciliation.
• Execute eTMF Quality Control Plan.
• Update manuals/documents (e.g., patient diaries, instructions).
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders.
• Obtain translations of documents.

Regulatory & Site Start-Up responsibilities

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions.
• Obtain, track and update study insurance certificates.
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation.

Budgeting, Agreement and Payments

• Develop, control, update and close-out country and site budgets (including Split site budget).
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs).
• Track and report contract negotiations.
• Update and maintain contract templates (in cooperation with Legal Department).
• Calculate and execute payments (to investigators, vendors, grants).
• Ensure adherence to financial and compliance procedures.
• Monitor and track adherence and disclosures.
• Maintain tracking tools.
• Obtain and process FCPA documentation in a timely manner.

Meeting Planning

• Organize meetings (create & track study memos/letters/protocols).
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable).

Skills

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role.
• Excellent negotiation skills for CTCs in finance area.
• Effective time management, organizational and interpersonal skills, conflict management.
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally.
• Able to work independently.
• Proactive attitude to solving problems / proposing solutions.
• Positive mindset, growth mindset.

Qualification & Experience

• Completed job training (office management, administration, finance, health care preferred) or 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-Focused
• Microsoft Excel
• Microsoft Office

Preferred Skills

• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Communication

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Remote

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 11/10/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The salary range for this role is: $68,000 - $107,000

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.