Senior Clinical Trial Coordinator (Sr. CTC) - Remote

Merck

Topeka (KS)

Remote

USD 74,000 - 118,000

Full time

5 days ago

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Benefits offered by this job

Annual bonus and long-term incentive

Medical, dental and vision insurance

401(k) and paid holidays

Job summary

Merck & Co., Inc. in the United States is seeking a Clinical Trial Coordinator to support trial and site administration, compliance with GCP and documentation standards, and collaboration with finance and regulatory teams. Role includes preparing submission packages for IRB/ERC and Health Authorities.

The position emphasizes process improvement, training, and mentoring junior CTCs, with remote work flexibility and a strong focus on document management and tracking tools.

Qualifications

Minimum 3 years in Clinical Research or relevant healthcare experience.
Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

Responsibilities

Track essential documents and reports (e.g., Safety Reports).
Collate, distribute, and archive clinical documents (eTMF); update CTMS trackers.
Support site start-up, IRB/ERC submissions, and regulatory packages.
Manage budgeting, CTRAs, payments, and contracts in collaboration with Finance and Legal.
Organize meetings and support investigator meetings; provide training and mentorship to junior staff.

Skills

Clinical Research

CTA (Clinical Trial Agreements)

GCDMP

Microsoft Excel

Time Management

Training Delivery

Leadership

Communication

Budgeting

Regulatory Knowledge

Education

Bachelor’s Degree

Office management/training or healthcare-related training

Tools

CTMS

MS 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.

The person acts as process Subject Matter Expert (SME), making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior CTCs.

Responsibilities include, but are not limited to:

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:

Collaborate with finance/budgeting representatives for:

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).

Quality & Oversight:

Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Mentors / buddies to junior CTCs (including, but not limited to process requirements).

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.
Highly 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 taking full ownership of delegated tasks.
Proactive attitude to solving problems / proposing solutions.
Positive mindset, growth mindset.
Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Qualification & Experience:

Minimum 3 years in Clinical Research or relevant healthcare experience.
Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

The salary range for this role is: $74,000 - $117,900

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.

Required Skills:

Clinical Research, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Customer-Focused, Good Clinical Data Management Practice (GCDMP), Microsoft Excel, Microsoft Office, Time Management, Training Delivery

Preferred Skills:

Clinical Trial Management Systems (CTMS), Clinical Trials, Leadership

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.

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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License: