Research Associate jobs in Altoona, FL

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Regulatory Associate
  • CHARTER RESEARCH
  • The Villages, FL FULL_TIME
  • POSITION OVERVIEW   
    The Regulatory Associate is responsible for processing regulatory packets and documents for each clinical trial protocol, maintaining regulatory files, and facilitating Institutional Review Board (IRB) submissions.

    RESPONSIBILITIES
    1. Prepare regulatory documents for new study submissions to the IRB and sponsor. Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.
    2. Review Informed Consent Form (ICF) drafts and incorporate suggested revisions in alignment with clinical operations, the IRB, and sponsor.
    3. Inform clinical operations of new IRB approvals including initial approval, protocol amendments, consent forms, and other subject-facing materials. Provide guidance regarding implementation and training requirements.
    4. Verify protocol training is completed prior to assigned team members completing the Delegation of Authority (DOA) logs.
    5. Maintain regulatory files in an “audit-ready” status at all times by ensuring documentation and filings are up to date.
    6. Meet with study monitors during interim monitoring visits to ensure resolution of outstanding regulatory document issues within an appropriate time frame.
    7. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.
    8. Track IRB approval expiration dates and submit continuing review reports to the IRB prior to the deadline to avoid lapses in approval.
    9. Communicate with study sponsors regarding any revised site information and notify the IRB as required.
    10. Receive, track, and distribute Investigational New Drug (IND) Safety Reports to the Principal Investigator for acknowledgement of review and file.
    11. Ensure all regulatory books are updated at final monitoring closeout visits and notify the IRB of closure.
    12. Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
    13. Maintain documentation of staff credentials and qualifications (e.g., CVs, licenses, GCP) and facilitate updates and / or renewal as required.
    14. Perform ad-hoc projects and/or general office duties as requested.

    KNOWLEDGE, SKILLS, AND ABILITIES
    1. Ability to handle multiple tasks/projects simultaneously.
    2. Exceptional planning/organizational skills and attention to detail.
    3. Strong verbal and written communication skills.
    4. Ability to work well both independently and as part of a team.
    5. Must possess a high degree of integrity and ability to handle confidential information appropriately.

    QUALIFICATIONS
    Education
    1. Associate’s degree required.  Bachelor’s degree preferred.
    Experience
    1. 1 year of clinical research experience preferred.

    PHYSICAL REQUIREMENTS
    1. Prolonged periods of sitting at a desk and working on a computer.
    2. Prolonged periods of standing, bending, and reaching.

  • 5 Days Ago

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Patient Recruitment Associate
  • Charter Research
  • Orlando, FL FULL_TIME
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill ...
  • 13 Days Ago

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Patient Recruitment Associate
  • CHARTER RESEARCH
  • Winter Park, FL FULL_TIME
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Winter Park, FL that is looking to add to our team to help us fulf...
  • 15 Days Ago

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Research Assistant
  • CHARTER RESEARCH
  • The Villages, FL FULL_TIME
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Winter Park, FL that is looking to add to our team to help us fulf...
  • 25 Days Ago

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Research Assistant
  • Charter Research
  • Orlando, FL FULL_TIME
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill ...
  • 15 Days Ago

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Research Assistant
  • Charter Research
  • Winter Park, FL FULL_TIME
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Winter Park, FL that is looking to add to our team to help us fulf...
  • 1 Month Ago

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0 Research Associate jobs found in Altoona, FL area

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Research Assistant
  • DLCFL
  • Orlando, FL
  • Job Description Job Description We are seeking a Research Assistant to become an integral part of our team! You will ass...
  • 4/30/2024 12:00:00 AM

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Clinical Research Coordinator CRC / RN
  • Omega Research
  • Orlando, FL
  • Job Description Job Description Here we grow again! Our busy clinical research sites in Debary and Orlando are looking f...
  • 4/30/2024 12:00:00 AM

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Research Associate (Remote First - Los Angeles or Minneapolis Only)
  • Murphy Research
  • Orlando, FL
  • Murphy Research is a full-service custom market research firm known for our innovative research design and consultative ...
  • 4/29/2024 12:00:00 AM

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Regulatory Specialist
  • Actalent
  • Altamonte Springs, FL
  • Description: Responsible for assisting with the submission of research protocols and other required documents/components...
  • 4/29/2024 12:00:00 AM

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Information Technology Coordinator
  • Brooksource
  • Orlando, FL
  • IT Coordinator Contract to Hire Hourly Rate: $35/hr Hybrid On-Site Schedule Orlando, FL The IT Coordinator is responsibl...
  • 4/29/2024 12:00:00 AM

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Research Associate (Remote First - Los Angeles or Minneapolis Only)
  • Murphy Research
  • Orlando, FL
  • Murphy Research is a full-service custom market research firm known for our innovative research design and consultative ...
  • 4/28/2024 12:00:00 AM

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Research Assistant
  • Charter Research
  • The Villages, FL
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The...
  • 4/28/2024 12:00:00 AM

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Research Assistant
  • Charter Research
  • The Villages, FL
  • COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based in The...
  • 4/26/2024 12:00:00 AM

Altoona is an unincorporated census-designated place in Lake County, Florida, United States. The population was 88 at the 2000 United States Census. It is part of the Orlando–Kissimmee–Sanford Metropolitan Statistical Area. Altoona is located at 28°57′57″N 81°38′54″W / 28.96583°N 81.64833°W / 28.96583; -81.64833 (28.965742, -81.648453). According to the United States Census Bureau, the CDP has a total area of 0.5 square miles (1.3 km2), of which 0.4 square miles (1.0 km2) is land and 0.1 square miles (0.26 km2) (12.00%) is water....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Research Associate jobs
$53,846 to $68,684
Altoona, Florida area prices
were up 1.5% from a year ago

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