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 Clinical Trial Coordinator supports clinical supply and 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 Clinical Operations Manager, Clinical Research Manager and Clinical Research Associate. 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 Clinical Trial Coordinators.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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 Global Clinical Trial Organisation and Regulatory Affairs where required per local legislation.
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 documentation in a timely manner
- Meeting Planning
- Organize meetings (create & track study memos/letters/protocols).
- Support local investigator meetings (invitations, prepare materials, select
- Quality & Oversight
- Contribute strongly to Clinical Trial Coordinator team knowledge by acting as process Subject.
- Mentors / buddies junior Clinical Trial Coordinators (including, but not limited to process requirements).
Qualifications, Skills & Experience
- 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 Clinical Trial Coordinators 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 Clinical Trial Coordinator team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.
- Minimum 3 - 5 years in Clinical Research or relevant healthcare 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 world's 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.
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.
What We Look For
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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
Regular
Relocation
No relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Shift
Valid Driving License
Hazardous Material(s)
Requisition ID R230961
