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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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  • Administrative Assistant
    Administrative Assistant
    23 days ago
    $35000–$40000 yearly
    Part-time
    Manhattan, New York

    Working in Harlem, Street Corner Resources a non-profit organization, enhances the lives of young adults and community members by delivering a clear pathway to opportunity. We provide essential resources for education, job training, and employment to combat gun violence and build a more empowered, resilient community. Administrative Assistant About the Role We are seeking a highly organized and proactive Administrative Assistant to join our team. In this role, you will be the backbone of our office, ensuring smooth daily operations by providing comprehensive support to our leadership and staff. You will manage administrative tasks, coordinate schedules, and assist with a variety of clerical, financial, and strategic activities. This position requires a motivated and detail-oriented individual with exceptional communication and multitasking abilities. Key Responsibilities • Office & Calendar Management: Oversee daily office operations, including managing office schedules and the CEO's calendar., • Coordination: Organize and distribute program invitations and notices, ensuring all stakeholders are informed., • Administrative Support: Maintain and update both digital and physical files, proofread documents, and prepare expense reports., • Communication: Serve as a primary point of contact by answering routine telephone calls and referring visitors to the appropriate staff., • Procurement & Inventory: Recommend and manage the purchase of office materials and resources for staff and participants., • Digital Skills: Manage social media accounts and assist with researching and applying for grant opportunities., • Community Engagement: Research and gather information on relevant community activities to support organizational involvement., • Flexibility: Be available to work occasional evening hours and weekends as needed. Qualifications • A Bachelor's degree and two years of relevant administrative or clerical experience., • OR a High School diploma (or equivalent) and six years of relevant experience., • OR an equivalent combination of education and experience, including at least one year of administrative experience., • Demonstrated proficiency in administrative and clerical tasks., • Excellent planning, organizational, and multitasking skills., • Strong verbal and written communication abilities.

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