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  • Clinical Research Coordinator
    Clinical Research Coordinator
    4 days ago
    Full-time
    Morrisania, The Bronx

    Our Research facility/Urgent Care is looking for a full time Clinical Data Coordinator for various ongoing studies. The applicant must have good communication & organizational skills. The applicant must: Collect and document patient and regulatory data with exceptional attention to detail, submitting data promptly to appropriate persons or databases involved in research study. Ensures all data is accurate and entered in a timely manner. Works with research team to resolve all queries. Assists in the activities related to clinical research studies including but not limited to answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires. Facilitate and attend monitor meetings. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. Establish and maintain regular communication with study team, study sponsor, and applicable regulatory agencies to ensure all required information is communicated. Minimum Qualifications Bachelor's degree with 1-2 years related experience; or combination of equivalent education/Clinical Research experience. Work Remotely No Job Type: Full-time Schedule: Monday to Friday Ability to Commute: Bronx, NY 10456 (Required) Ability to Relocate: Bronx, NY 10456: Relocate before starting work (Required) Work Location: In person

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  • Regulatory Affairs Consultant
    Regulatory Affairs Consultant
    8 days ago
    Full-time
    Hartsdale

    JOB SUMMARY: We are seeking an experienced Regulatory Affairs Consultant to provide expert guidance on compliance, documentation, and regulatory strategy. The consultant will support product registrations, regulatory submissions, audits, and ensure adherence to all applicable local, federal, and industry regulations. KEY RESPONSIBILITIES: Develop and implement regulatory strategies to support product approvals and compliance. Prepare, review, and submit regulatory documents, reports, and technical files. Ensure products meet regulatory requirements across relevant markets. Advise on regulatory changes, updates, and potential business impacts. Coordinate with internal teams to ensure documentation accuracy and readiness for audits. Communicate with regulatory agencies as needed for approvals or clarifications. Conduct compliance assessments and recommend corrective actions. Maintain detailed records of submissions, approvals, and regulatory correspondence. QUALIFICATIONS: Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, Biotechnology, or related field. Proven experience in regulatory affairs within relevant industry (e.g., pharmaceuticals, medical devices, cosmetics, food, etc.). Strong knowledge of regulatory standards and submission processes. Excellent analytical, documentation, and communication skills. Ability to manage multiple projects and deliver within deadlines. PREFERRED SKILLS: Experience with FDA, EMA, or local regulatory authorities. Familiarity with quality management systems (ISO standards). Strong attention to detail and problem-solving skills. WORK SETUP: Contract / Consultant Remote or On-site depending on project needs

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