Research Associate - Biotech jobs in Orlando, FL

Research Associate - Biotech performs analytical tests and experiments in support of biotech research projects. Operates laboratory equipment and instruments. Being a Research Associate - Biotech utilizes scientific software to interpret and record test results. Experienced with standard chemistry and molecular biology lab practices and techniques. Additionally, Research Associate - Biotech requires a bachelor's degree. Typically reports to a supervisor. The Research Associate - Biotech work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Research Associate - Biotech typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

C
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.

  • 1 Day Ago

C
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 ...
  • 9 Days Ago

C
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...
  • 11 Days Ago

P
Open Applications
  • PSC Biotech
  • Orlando, FL FULL_TIME
  • At PSC Biotech, we believe that the right opportunity doesn't always come at the perfect time. That's why we encourage individuals who are interested in joining our team to apply, regardless of whethe...
  • 2 Days Ago

C
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...
  • 21 Days Ago

C
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 ...
  • 11 Days Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Research Associate - Biotech jobs found in Orlando, FL area

U
Research Associate, Florida Space Institute
  • University of Central Florida
  • Orlando, FL
  • The Opportunity The Florida Space Institute (FSI) at the University of Central Florida (UCF) invites applications for mu...
  • 4/26/2024 12:00:00 AM

U
Research Program Coordinator (TEMP)
  • University of Central Florida
  • Orlando, FL
  • The Opportunity: The Valle Lab at the University of Central Florida (UCF) College of Medicine (COM) Burnett School of Bi...
  • 4/26/2024 12:00:00 AM

D
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...
  • 4/25/2024 12:00:00 AM

O
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...
  • 4/25/2024 12:00:00 AM

A
Healthcare Compliance Analyst- Remote
  • AmICompliant
  • Orlando, FL
  • Intern Job Description: Healthcare Industry Outreach and Compliance Research Position Overview: We are a start-up seekin...
  • 4/25/2024 12:00:00 AM

C
Data Coordinator
  • Charter Research
  • Orlando, FL
  • Data Coordinator Winter Park COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical r...
  • 4/22/2024 12:00:00 AM

C
Data Coordinator
  • Charter Research
  • Orlando, FL
  • Data Coordinator Winter Park COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical r...
  • 4/22/2024 12:00:00 AM

A
Healthcare Compliance Analyst- Remote
  • Amicompliant
  • Orlando, FL
  • Intern Job Description: Healthcare Industry Outreach and Compliance Research Position Overview: We are a start-up seekin...
  • 4/22/2024 12:00:00 AM

Orlando (/ɔːrˈlændoʊ/) is a city in the U.S. state of Florida and the county seat of Orange County. Located in Central Florida, it is the center of the Orlando metropolitan area, which had a population of 2,509,831, according to U.S. Census Bureau figures released in July 2017. These figures make it the 23rd-largest metropolitan area in the United States, the sixth-largest metropolitan area in the Southern United States, and the third-largest metropolitan area in Florida. As of 2015, Orlando had an estimated city-proper population of 280,257, making it the 73rd-largest city in the United State...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Research Associate - Biotech jobs
$43,872 to $54,956
Orlando, Florida area prices
were up 1.5% from a year ago