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 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 - 5 years in Clinical Research or relevant healthcare experience

Completed job training (office management administration finance health care preferred) or Bachelors Degree.

Required Skills:

Preferred Skills:

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