Senior Clinical Trial Coordinator

Job not on LinkedIn

🔥 15 hours ago

🌐 United States, Puerto Rico – Remote

🇺🇸 United States – Remote 🇵🇷 Puerto Rico – Remote

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $74k - $117.9k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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MSD

WebsiteLinkedInAll Job Openings

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 comprehensive trial and site administration under line-manager oversight • Prepare, collate, distribute, and archive clinical documents • Support clinical and non-clinical supply management • Maintain tracking and reporting tools, clinical trial databases, and CTMS • Assist with meeting planned Site Ready dates • Assist with IRB/ERC and Health Authority submission packages • Collaborate with COM, CRM, CRA, finance, and budgeting representatives • Manage labeling requirements and coordinate translation change requests • Prepare, distribute, archive, and quality-control eTMF documents • Assist with eTMF reconciliation and execute the eTMF Quality Control Plan • Update manuals and documents, including patient diaries and instructions • Prepare Investigator trial file binders and obtain document translations • Obtain, 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 CTRAs and contract templates • Track contract negotiations and calculate and execute payments • Ensure adherence to financial and compliance procedures • Monitor disclosures and process FCPA documentation • Organize meetings and prepare study memos, letters, and protocols • Support local investigator meetings and associated vendors • Act as process Subject Matter Expert, share best practices, recommend improvements, and provide training • Mentor and buddy junior CTCs

🎯 Requirements

• Minimum 3 years in Clinical Research or relevant healthcare experience • Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree • 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 prioritize and handle multiple tasks in a changing environment • Ability to work effectively in a matrix multicultural environment • Ability to work independently and take ownership of delegated tasks • Proactive problem-solving attitude • Clinical Research • Clinical Trial Agreements (CTA) • Clinical Trial Compliance • Clinical Trial Management • Good Clinical Data Management Practice (GCDMP) • Microsoft Excel • Microsoft Office • Time Management • Training Delivery

🏖️ Benefits

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

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