There are many careers in clinical research. Our institute only offers training on some of the careers that we currently employed through our consulting firm. However, you will be given more information about all other career opportunities in clinical research when you purchased any of our training program.
Research & Development
A drug or medical device sponsor develops a new product and seeks FDA evaluation. A Regulatory Affairs Specialist guides the sponsor through regulatory requirements and the submission process. Our Regulatory Affairs program teaches the responsibilities and processes involved in this role. Graduates may also pursue related positions within the Regulatory Affairs department, such as Quality Control Specialist, Quality Assurance Specialist, and other compliance-focused roles.
Regulatory Affairs jobs involves:
Medical device Pre-Market Applications and Notifications (PMA or 510(k)), de novo review process, and pre-submission meeting processes.
Laboratory, pre-clinical, and clinical trial processes and requirements, including ICH and FDA requirements and good clinical practice guidelines.
NDA and ANDA, Biologics License Application (BLA), the pre-Investigational New Drug (pre-IND) and IND submission and review processes and the Drug Efficacy Study Initiative (DESI) evaluation process.
Current good manufacturing practices (cGMPs) applicable to drugs and dietary supplements (FDA, ICH, etc.), AND/OR medical device quality system regulations (QSR).
Medical device and drug product reviews and classifications; medical product labeling reviews; indication for use and directions for use; monograph reviews; scientific and clinical data and other evidentiary reports; and similar medical products related matters.
Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies on regulatory and enforcement matters, such as responses to Inspectional Observations (Form FDA 483), and to untitled and warning letters.
Advise clients during regulatory inspections and interact with regulators and inspectors, including State Boards of Pharmacy and FDA.
Perform regulatory reviews of client files and product materials.
Draft standard operating procedures (SOPs), manuals, and policies for clients to implement and improve business processes and for compliance with regulatory requirements.
Communicate effectively, professionally, knowledgeably, and in a timely manner, both orally and in writing to managers, colleagues, clients and government agencies while maintaining appropriate Firm image.
Advise clients on regulatory requirements applicable to medical products, on pathways to lawful marketing, and on bringing medical products into compliance.
Read, analyze, and interpret regulations and policies of FDA, Customs, and other federal and local regulatory agencies.
Read and analyze articles in scientific, regulatory, and technical journals.
Support business development marketing efforts of the Firm and many more......
What is Validation? What does a validation Engineer do?
A Validation Engineer may also work for the Regulatory Affairs department, or the Validation Department depending on the size of the company. Validation is usally done as a project.
There are different types of validation.
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Analytical method validation
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Process validation
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Cleaning validation
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Equipment validation
There are types or stages) of Qualification:
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Design qualification (DQ)
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Installation qualification (IQ)
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Operational qualification (OQ)
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Performance qualification (PQ)
A Validation Engineer daily job description include:
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Developing Standards, Guidelines and SOP to enhance the quality of manufacturing operations.
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Performing IQOQPQ Validation of Facilities, Utilities, Equipment, and Process.
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Developing and sharing validation expertise and scientific understanding of key Pharmaceutical Operations.
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Acting as an SME in validation approaches (e.g., Facility, Utility, Equipment, Process)
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Acting as an SME in validation activities such as Computer System Validation CFR11, and Risk-Based approaches.
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Coordinating and collaborating with cross-functional teams in achieving successful project milestones.
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Leading all projects customizing project management methodologies to suit the project's specific scope.
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Supporting projects from new product development to technology infrastructure, based on the client needs.
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Creating and upholding project plans, schedules, and resource tracking mechanisms for assigned projects.
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Developing, executing, and documenting validation programs for facilities/utilities and equipment.
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Developing validation protocols for both internally and for externally manufactured products.
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Supporting products through Process Design, Process Qualification and Continuous Process Verification
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Developing and leading Validation Master plans, in collaboration with manufacturing sites.
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Executing validation projects and ensure that Quality and Regulatory guidelines are enforced.
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Executing, providing guidance and oversight and for site validation of facilities/utilities, and equipment.
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Developing risk-based approaches to revalidation of products, processes, and systems.
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Our Validation Program prepares our students to be industry ready, to obtain a career as an entry level Validation Engineer.
Clinical Research Associate's (CRA's) must be GCP trained. The position entails managing and monitoring clinical trials at the study sites and ensuring clinical trials are conducted, recorded and reported in accordance with the protocol designed, the standard operating procedures, ICH/GCP, ISO 14155 and all applicable regulatory requirements.
A CRA job duties also include
● Performing monitoring activities at investigational sites.
● Collaborating with cross-functional teams (e.g., data management and partner CROs), with query management, data reviews and resolution.
● Conducting source data verification (SDV) of patient medical charts required per monitoring plan
● Conducting reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with SOPs, Good Documentation Practices and applicable regulations.
● Managing progress of contracts and monitoring CRO CRAs for respective sites.
● Providing oversight of and insight into trial activities (e.g., protocol compliance, enrollment, monitoring deviations, data quality).
● Managing and reviewing site invoices as per the study contracts
● Contributing to the development of clinical protocols, informed consent forms, and case report forms.
● Validating investigational device accountability by tracking the history of investigational devices from Bolt to the field sites and through final disposition.
● Supporting audits and inspections, as needed and many more.....
Our CRA program prepare our students to be industry ready to obtained a job as a Clinical Research Associate with a college degree, or Clinical Research Cordinator if they have a high school diploma.
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