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Clinical Trial Coordinator – Monitoring

🔥 16 hours ago

🏖️ New Jersey – Remote

infoinfo

💵 $68k - $107k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

Where this job comes from

Posted on MSD's careers page, not through a job board

First seen by Remote Rocketship 16 hours ago

Still open on MSD's site. Checked 35 minutes ago.

Logo of MSD

MSD

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Provide trial and site administration support, including data tracking and reporting • Prepare, collate, distribute, and archive clinical documents • Support clinical and non-clinical supply management • Maintain clinical trial databases, CTMS, trackers, and reporting tools • Manage labeling requirements and coordinate translation change requests • Prepare documents and correspondence and assist with eTMF reconciliation • Execute the eTMF Quality Control Plan • Update manuals and documents, including patient diaries and instructions • Document proper destruction of clinical supplies • Prepare Investigator trial file binders and obtain document translations • Support site evaluation, validation, start-up, and regulatory submissions • Track and update study insurance certificates • Publish study results where required by local legislation • Develop, control, update, and close out country and site budgets • Develop, negotiate, approve, and maintain contracts such as CTRAs • Track contract negotiations and maintain contract templates with Legal • Calculate and execute payments to investigators, vendors, and grants • Ensure adherence to financial and compliance procedures • Monitor and track adherence and disclosures • Obtain and process FCPA documentation • Coordinate meetings and site visits, track and analyze study data, and prepare reports • Support local investigator meetings, including invitations, materials, venue selection, and vendor support • Collaborate with Clinical Operations Managers, Clinical Research Managers, Clinical Research Associates, finance, and budgeting representatives

🎯 Requirements

• Fluent in local languages and business proficient in English, verbal and written • Good understanding of Global, Country/Regional Clinical Research Guidelines • Hands-on knowledge of Good Documentation Practices • Good IT skills, including MS Office and clinical IT applications • Strong MS Excel skills • ICH-GCP knowledge appropriate to the role • Excellent negotiation skills for CTCs in finance area • Effective time management, organizational, interpersonal, and conflict management skills • Effective communication with external customers, sites, and investigators • Ability to set priorities and handle multiple tasks simultaneously in a changing environment • Ability to work effectively in a matrix multicultural environment • Ability to establish and maintain culturally sensitive working relationships • Customer-focused mindset • Ability to work independently • Proactive attitude to solving problems and proposing solutions • Positive and growth mindset • Completed job training in office management, administration, finance, or health care, or a bachelor's degree • No visa sponsorship available • Valid driving license not required

🏖️ Benefits

• Annual bonus and long-term incentive, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement • 10% travel requirement • No relocation required

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