Sr. Clinical Trial Coordinator

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:

o Track (e.g. essential documents) and report (e.g. Safety Reports)

o Ensure collation and distribution of study tools and documents

o Update clinical trial databases (CTMS) and trackers

o Clinical supply & non-clinical supply management, in collaboration with other country roles

o Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

• Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents, e.g. eTMF

o Assist with eTMF reconciliation

o Execute eTMF Quality Control Plan

o Update manuals/documents (e.g., patient diaries, instructions)

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders

o Obtain translations of documents

• Regulatory & Site Start-Up responsibilities:

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

o Obtain, track and update study insurance certificates

o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

o Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for:

o Develop, control, update and close-out country and site budgets (including

Split site budget)

o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)

o Track and report contract negotiations

o Update and maintain contract templates (in cooperation with Legal

Department)

o Calculate and execute payments (to investigators, vendors, grants)

o Ensure adherence to financial and compliance procedures

o Monitor and track adherence and disclosures,

o Maintain tracking tools

o Obtain and process FCPA documentation in a timely manner

• Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)

o Support local investigator meetings (invitations, prepare materials, select

venue, support vendor where applicable)

• Quality & Oversight:

o 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.

o Mentors / buddies 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 - 5 years in Clinical Research or relevant healthcare experience

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:10/28/2024

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.

Requisition ID:R305372