Scientist - Clinical Research jobs in Georgia

Scientist - Clinical Research assumes lead role in various clinical research projects. Proposes, plans, organizes and executes experiments and research. Being a Scientist - Clinical Research secures grants and funding for research and is responsible for controlling budgets. Summarizes findings in reports and communicates results. Additionally, Scientist - Clinical Research interacts with other scientists within and outside of the organization. Provides recommendations that influence extensive clinical research activities. Requires an advanced degree. Typically reports to head of a unit/department. The Scientist - Clinical Research work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. To be a Scientist - Clinical Research typically requires 4 -7 years of related experience. (Copyright 2024 Salary.com)

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Clinical Research Regulatory Specialist
  • Alcanza Clinical Research
  • Decatur, GA FULL_TIME
  • Department: Quality, Regulatory & Source

    Employment Type: Full Time

    Location: Accel Research Sites - Decatur, GA

    Reporting To: Melissa Hodges

    Description

    Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

    The Regulatory Specialist is responsible for regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance. The RC maintains communication with the IRB and reviews on-site files, folders, binders, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides training and/or initiates corrective action as required. Ensures that essential documents are organized, up to date, and in compliance with ICH/GCP guidelines and federal regulations. Assists site-focused reviews, and quality improvement activities.

    Key Responsibilities

    Essential Job Duties:

    • Maintains regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies throughout the life of the studies. Keeps documents organized and ready for audit and ready for regulatory filings when required;
    • Follows the organization's SOPs and provides guidance with staff comprehension and compliance with the SOPs;
    • Facilitates communication with the IRB and/or Sponsors.
    • Assists with and coordinates the development of clinical trial support documents. Assists with all regulatory filings.
    • Ensures IND safety reports are distributed to investigators and the research team for review.
    • Assembles reproduces, and archives (hard and electronic copies) technical documents, as appropriate for the document type.
    • Collaborates with the research team to facilitate overall protocol operations;
    • Identifies problems and issues and takes corrective action and/or escalates appropriately;
    • Tracks sponsor and IRB approvals and renewals;
    • Reports on the status of clinical trials;
    • Generates and reviews reports of regulatory data using appropriate systems;
    • Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP;
    • Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations;
    • Assists in training programs as requested;
    • Perform all other duties that may be requested or assigned.
    • This position can be remote with local travel to the site in Decatur, GA

    Skills, Knowledge And Expertise

    Minimum Qualifications: A Bachelor's degree and a minimum of 2 years experience in clinical research, OR an equivalent combination of education and experience, is required. 1 years of regulatory experience is preferred. Knowledge of GCP/ICH guidelines is required.

    Required Skills

    • Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40 wpm).
    • Must possess strong organizational skills, attention to detail, and basic math proficiency.
    • Well-developed written and verbal communication skills.
    • Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
    • Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
    • Must be professional, respectful of others, self-motivated, and have a strong work ethic.
    • Must possess a high degree of integrity and dependability.
    • Ability to work under minimal supervision, identify problems and assist in implementing solutions.
    • Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

    Benefits

    • Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
    • Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
  • 8 Days Ago

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Senior Clinical Research Associate
  • Everest Clinical Research
  • Watkinsville, GA FULL_TIME
  • Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechn...
  • 13 Days Ago

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Clinical Research Scientist
  • Diagnostic Solutions Laboratory
  • Alpharetta, GA FULL_TIME
  • Clinical Research Scientist/Clinical Assay DeveloperJob DescriptionDiagnostic Solutions Laboratory is looking for a Clinical Research Scientist to join our Assay Development team. In this position, yo...
  • 17 Days Ago

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Research Assistant
  • Alcanza Clinical Research
  • Decatur, GA FULL_TIME
  • Department: OperationsEmployment Type: Full TimeLocation: Accel Research Sites - Decatur, GAReporting To: Adrienne HillDescriptionAlcanza is a growing multi-site, multi-phase clinical research company...
  • 5 Days Ago

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Clinical Research Regulatory Specialist (Remote with travel to Decatur, GA site as needed)
  • Alcanza Clinical Research
  • Decatur, GA FULL_TIME
  • Clinical Research Regulatory Specialist (Remote with travel to Decatur, GA site as needed)Department: Quality, Regulatory & SourceEmployment Type: Full TimeLocation: Accel Research Sites - Decatur, GA...
  • 2 Months Ago

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PRN Research Assistant
  • Alcanza Clinical Research
  • Decatur, GA PART_TIME
  • PRN Research AssistantDepartment: Operations Employment Type: Part TimeLocation: Accel Research Sites - Decatur, GAReporting To: Adrienne HillDescriptionAlcanza is a growing multi-site, multi-phase cl...
  • 26 Days Ago

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Scientific Director, Clinical Scientist, Oncology Early Development
  • AbbVie, Inc.
  • South San Francisco, CA
  • In collaboration with a therapeutic area, the Scientific Director, Clinical Science will lead the design, conduct, analy...
  • 6/11/2024 12:00:00 AM

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Principal Scientist, Clinical Research
  • J&J Family of Companies
  • Cincinnati, OH
  • Principal Scientist, Clinical Research - 2406190642W **Description** Johnson & Johnson, we believe health is everything....
  • 6/10/2024 12:00:00 AM

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FEMA - Scientific Specialist (Nationwide Openings)
  • Idaho State Job Bank
  • Nampa, ID
  • FEMA - Scientific Specialist (Nationwide Openings) at CDM Smith in Nampa, Idaho, United States Job Description 27234BR R...
  • 6/9/2024 12:00:00 AM

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FEMA - Scientific Specialist (Nationwide Openings)
  • Idaho State Job Bank
  • Idaho Falls, ID
  • FEMA - Scientific Specialist (Nationwide Openings) at CDM Smith in Idaho Falls, Idaho, United States Job Description 272...
  • 6/9/2024 12:00:00 AM

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Principal Scientist, Clinical Research, Breast Cancer
  • Merck
  • Rahway, NJ
  • **Job Description** Our company is a global health care leader with a diversified portfolio of prescription medicines, v...
  • 6/8/2024 12:00:00 AM

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Associate Scientist / Scientist
  • Meet
  • Thousand Oaks, CA
  • I am partnered with an exciting Biotech company out of Thousand Oaks, CA looking to grow their team with an Associate Sc...
  • 6/8/2024 12:00:00 AM

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Senior Scientist
  • Meet
  • Ridgefield, CT
  • Our esteemed client, a leading top 20 pharmaceutical company known for its continuous growth, is seeking a Senior Scient...
  • 6/7/2024 12:00:00 AM

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Process Development, Senior Scientific Specialist (Contract)
  • Vertex Pharmaceuticals
  • Boston, MA
  • Job Description: General Summary: Vertex is looking for a talented individual to join our team as a scientific specialis...
  • 6/7/2024 12:00:00 AM

Georgia is a state in the Southeastern United States.Beginning from the Atlantic Ocean, the state's eastern border with South Carolina runs up the Savannah River, northwest to its origin at the confluence of the Tugaloo and Seneca Rivers. It then continues up the Tugaloo (originally Tugalo) and into the Chattooga River, its most significant tributary. These bounds were decided in the 1797 Treaty of Beaufort, and tested in the U.S. Supreme Court in the two Georgia v. South Carolina cases in 1923 and 1989. The border then takes a sharp turn around the tip of Rabun County, at latitude 35°N, thou...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Scientist - Clinical Research jobs
$81,151 to $115,380

Scientist - Clinical Research in Savannah, GA
Most scientists choose to complete a dual degree, in both science and medicine.
January 10, 2020
Scientist - Clinical Research in Fort Wayne, IN
Natural sciences managers supervise the work of scientists, including chemists, physicists, and biologists.
February 15, 2020
Scientist - Clinical Research in Norwich, CT
Research projects may be aimed at improving manufacturing processes, advancing basic scientific knowledge, or developing new products.
December 15, 2019