Top Clinical Research Executive jobs in Georgia
Top Clinical Research Executive plans and directs all aspects of the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Top Clinical Research Executive ensures adherence to SOPs, Good Clinical Practice and FDA regulations. Requires an advanced degree. Additionally, Top Clinical Research Executive typically reports to top management. The Top Clinical Research Executive manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. To be a Top Clinical Research Executive typically requires 8+ years of managerial experience. Comprehensive knowledge of the overall departmental function. (Copyright 2024 Salary.com)
Recently Added Top Clinical Research Executive jobs
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
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.
- 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
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
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
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
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
Clinical Rater
- Alcanza Clinical Research
-
Decatur, GA
FULL_TIME
- Department: OperationsEmployment Type: FlexibleLocation: Accel Research Sites - Decatur, GAReporting To: Adrienne HillDescriptionAlcanza is a growing multi-site, multi-phase clinical research company ...
- 12 Days Ago
Top Clinical Research Executive jobs at Popular Companies
Data Research Team Member The Mansour Group
- Marcus & Millichap
-
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Clinical Research Professional
- UpTrials
-
- Description We are looking for an entry to mid=level professional with at least 1 year of prior clinical research experi...
- 6/10/2024 12:00:00 AM
Faculty Research Staff Member
- LLNL
-
Livermore, CA
- Company Description Join us and make YOUR mark on the World! Come join Lawrence Livermore National Laboratory (LLNL) whe...
- 6/10/2024 12:00:00 AM
Research Professional
- University of Georgia
-
Athens, GA
- The research professionals responsibilities will be focused on performing independent research and providing technical a...
- 6/8/2024 12:00:00 AM
Investment Research Professional
- Leadenhall Search & Selection
-
- Leadenhall Search & Selection is recruiting for a growing Alternative Investment Advisory firm that has a global reach. ...
- 6/7/2024 12:00:00 AM
Research Staff Assistant
- Columbia University
-
New York, NY
- * Job Type: Support Staff - Non-Union * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $42,100-$50,000 ...
- 6/7/2024 12:00:00 AM
Coord Clinical Research II - Clinical Research Staff
- MetroHealth
-
Cleveland, OH
- **Location:** **METROHEALTH MEDICAL CENTER** **Biweekly Hours:** **80.00** **Shift:** **8-4:30** **The MetroHealth Syste...
- 6/7/2024 12:00:00 AM
Clinical Research Coordinator (Research Professional 1)
- University of Minnesota
-
Minneapolis, MN
- About the Job We are seeking a motivated and detail-oriented Clinical Research Coordinator (Research Professional 1) to ...
- 6/7/2024 12:00:00 AM
About Georgia
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 Top Clinical Research Executive jobs
$204,687 to $373,569