Clinical Trial Coordinator

Job Description

Clinical Trial Coordinator

Under the oversight of the linemanager this role is responsible for comprehensive trial and site administration and involves preparing collating distributing and archiving clinical documents. The CTC supports clinical supply nonclinical 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.

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 nonclinical 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 StartUp responsibilities Collaborate with other country roles to
• In a timely manner provide to and collect from investigators forms/lists for site evaluation/validation site startup 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 closeout 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.
• ICHGCP 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 Bachelors Degree

Who We Are

We are known as Merck Co. Inc. Rahway New Jersey USA in the United States and Canada and MSD everywhere else. For more than a century we have been inventing for life bringing forward medicines and vaccines for many of the worlds most challenging diseases. Today our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What We Look For

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here you have that opportunity. You can put your empathy creativity digital mastery or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving so if you are among the intellectually curious join usand start making your impact today.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.

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Remote Work :

No