Clinical Research Project Mgmt. and Trial Monitoring Training.

Qtech-Sol Professional Development Center" is Private Career School (Since 2000), offering Title and Job focused Clinical Science Practicum and Certificate Programs. Its Center for Career & Professional Development specializes in offering Career Advancement programs towards Clinical Research and Trials, Drug Safety-Pharmacovigilance, SAS Data Analytics, and Reporting, Clinical Research Data Management, Clinical Research project Management and Healthcare Business Analysis. Our certificate programs are backed and approved by New Jersey Department of Education (DOE) and the Department of Labor and Workforce Development (DOL), USA. We encourage students to take advantage of this educational learning offered, meeting to the learning required per job market and as hired by Pharmaceuticals, Medical Devices, Clinical Research Organization (CRO) and Research Hospitals.

CLINICAL RESEARCH AND TRIALS

Introduction

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials.

Background and history

The evolution of clinical research traverses a long and fascinating journey. From the first recorded trial of legumes in biblical times to the first randomized controlled of trial of streptomycin in 1946, the history of clinical trial covers a wide variety of challenges - scientific, ethical, and regulatory. The famous 1747 scurvy trial conducted by James Lind contained most elements of a controlled trial. The UK Medical Research Council's (MRC) trial of patulin for common cold in 1943 was the first double blind controlled trial. Th is paved the way for the first randomized control trial of streptomycin in pulmonary tuberculosis carried out in 1946 by MRC of the UK. This landmark trial was a model of meticulousness in design and implementation, with systematic enrolment criteria and data collection compared with the adhoc nature of other contemporary research. Over the years, as the discipline of controlled trials grew in sophistication and influence, the streptomycin trial continues to be referred to as ground breaking. The ethical advances in human protection include several milestones - Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Conference on Harmonization Good Clinical Practice guidance. In parallel to ethical guidelines, clinical trials started to become embodied in regulation as government authorities began recognizing a need for controlling medical therapies in the early 20th century. As the scientific advances continue to occur, there will be new ethical and regulatory challenges requiring dynamic updates in ethical and legal framework of clinical trials.

Background and history

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Phases of clinical trials

  • Preclinical research
  • Phase 0
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Informed consent provides the information about a clinical study, who can enroll or continue to participate in the study. It is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. IRB is federally supported to conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored. Clinical outcomes are measurable changes in health, function or quality of life that result from our care. Constant review of our clinical outcomes establishes standards against which to continuously improve all aspects of our practice.

Career paths in Clinical Research

Based on highest Education Background and Prior experience students can apply from Entry thru Senior roles, after certification.

Career Positions (Entry Level): Minimum Education: Associate
Related Experience (if any) : 0-12 Months
Eligible Job Titles: Clinical Office Assistant, Clinical Trial Assistant (CTA), Clinical Documentation Assistant, Trial Master File (TMF) Assistant.

Career Positions (Mid-Level): Minimum Education – Associate / Bachelors
Related Experience: 12-36 Months
Eligible Job Titles: Clinical Research Associate-Level I & II, Clinical Research Coordinator, Clinical Research Specialist, Clinical Site Monitor.

Career Positions (Senior): Minimum Education: Bachelors / Masters / PhD
Related Experience: 36 Months and Above
Eligible Job Titles: Clinical Research Associate - Level III, Clinical Program Manager, Clinical Trial Manager, Clinical Study Manager, Clinical Site / Project Manager, Clinical Study Monitor

What does a Clinical Research Professional (CRA) do?

Clinical Research Associate manages clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market. The CRA acts as a liaison between the study’s sponsor CRO (e.g., pharmaceutical company) and the clinics where the study takes place. Because results of a clinical trial must be kept entirely transparent and not influenced by the interests of the sponsor, this is a critical role. A successful CRA will be detail oriented, highly educated, and able to communicate clearly with both sponsor and clinical representatives. CRA Educates staff, patients, and referring health care providers about the trial. Communicates regularly with the principal investigator. Assists the principal investigator with the informed consent process, study monitoring, quality assurance, audits, and data management and analysis.

A Typical CRA performs the following duties

Responsible for the overall operational planning and activities for the implementation and conduct of global studies in compliance with GCPs, SOPs and standards within established timelines and budgets.

Oversight/interacted with CROs, other external vendors and sites to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team.

Collaborated with other functional team and provide operational input into study documents such as synopsis, protocol, ICF, CRF Completion Guidelines, development of contracts and budgets, Study Execution Plans, Communication Plan, Monitoring Plan, Clinical Data Review Plan, Clinical Databases edit specifications, SAE Management plan, Clinical Study Report (CSR), TMF, etc.

Facilitated study activities such as: internal protocol approval, vendor selection, CRO selection, Site selection (site feasibility/selection processes, IRB approvals), contracts and budgets negotiations, obtaining country/site insurance, study registration, review and approve initial regulatory package for drug shipment to the site, site activation, preparing for Investigators meeting, SIV visits, training CRA and site staff , and more.

Responsible for the overall operational planning and activities for the implementation and conduct of global studies in compliance with GCPs, SOPs and standards within established timelines and budgets.

Oversight/interacted with CROs, other external vendors and sites to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team.

Collaborated with other functional team and provide operational input into study documents such as synopsis, protocol, ICF, CRF Completion Guidelines, development of contracts and budgets, Study Execution Plans, Communication Plan, Monitoring Plan, Clinical Data Review Plan, Clinical Database edit specifications, SAE Management plan, Clinical Study Report (CSR), TMF, etc.

Facilitated study activities such as: internal protocol approval, vendor selection, CRO selection, Site selection (site feasibility/selection processes, IRB approvals), contracts and budgets negotiations, obtaining country/site insurance, study registration, review and approve initial regulatory package for drug shipment to the site, site activation, preparing for Investigators meeting, SIV visits, training CRA and site staff , and more.

Apply project management techniques to ensure time, quality, and safety standards are achieved

Provide input into study feasibility, study specifications, recruitment plans & determine country participation in Study

Ensure compliance of study with mandatory governance controls such as (Delegation of Authority, Study attestations, Letter of Assurance, Clinical Trial Disclosure, etc.)

Set-up, populate and accurately maintain information in tracking and communication tools and support others in the usage of these systems

Chair, create, distribute, and track meeting outcome with follow-up actions via meeting minutes and team communication

Perform quality control visits, contribute to individual and team development through training initiatives and team building activities.

Review data listings and patient profiles, coordinate with site and monitor data query/cleaning, resolve the queries in timely manner and thus meet Database lock timelines.

Perform close-out activities such as database lock (hard lock), site close-out, vendor close-out and reconciliation, CSR preparation and publication.

Prepare slides/presentation for weekly study updates, Monthly Operational meetings, investigators meeting etc.

Oversight the TMF set-up, perform TMF audit and quality review, and final reconciliation of study documents including review of sponsor/site documents.

In 2019, the global clinical trials market was valued at $46.8 billion and is predicted to continue at a compound annual growth rate (CAGR) of 5.1% over the next seven years. Although the outbreak Covid-19 has interrupted the progress of clinical trials and shifted much of workforce towards a remote model, the industry’s drive to deliver a vaccine against coronavirus will create the momentum needed to support the market’s growth. With the clinical trials market set for a promising future, a CRA job offers great career prospects and the opportunity to work in a highly rewarding role that improves the lives of patients.

Clinical Research Project Mgmt. and Trial Monitoring program (CRPM)

With increase in demand for more Clinical Research Professional hired by Research Hospitals, Pharmaceuticals, and various consulting organizations. We developed our basic certificate CRAT program in 2003 and later expanded to include advanced and additional modules (ACRA and AACR) in year 2006. Our team consists of Physicians, Pharmacy, Public Health, Biostatistics, Healthcare Administration and Computer science professionals.

Qtech-Sol (QPDC) Drug Safety training programs is backed and approved by US-Department of Education (DOE) and Department of Labor and Workforce Development (DOL (State of New Jersey) since 2015. Our programs are designed as self-driven distance learning programs with support, packed with various real-time exercises as tasks, along with solutions. These tasks are in par to duties and tasks performed in real-time by a Drug Safety Associate on real-world.

The mix of all 3 modules (CRAT + ACRA + AACR) is the current CRPM package program, packed with practicum needed meeting job needs.

Post Training Assistance (PTA Program) - Job Readiness Program.

Do your Know, most recruiters look for keywords that match to their client requirements. When you apply to a job, your resume competes against 250 other applicants, on average. It’s important that your resume stands out from your competition’s and showcases what you bring to the table. Get Started with PTA program and have your resume prepared well to be successful. Students connect with us to gain the practicum needed, get referral and avail help on Resume preparation, Narrative Writing, and avail Interview mock session. These proven steps followed have helped many to achieve their career goal since 2005.

Other Certificate and Package programs Offered

About Qtech-Sol

Qtech-Sol Professional Development Center (QPDC) certificate programs are backed and approved by New Jersey Department of Education (DOE) and the Department of Labor and Workforce Development (DOL), USA. We primarily focus on Clinical Research and Trials, Drug Safety-Pharmacovigilance, SAS Data Analytics, and Reporting, Clinical Research Data Management, Clinical Research project Management and Healthcare Business Analysis.