Clin Infotech

Clinical Research Coordinator Certification – CRC Training & Placement Program

Increase your job prospects with clinical research coordinator training program.

A clinical research coordinator (CRC), sometimes called a clinical trial manager, plays an integral role in medical studies of all kinds. They typically work under the direction of the principal investigator (PI), who is in charge of designing, conducting, and managing the clinical trial from a high level. It is the CRC’s job to support, facilitate, and organize daily clinical trial activities.

Clinical research coordinators also work in conjunction with the department, sponsor, and institution to guide them through compliance, finances, and personnel issues. In short, the CRC manages the day-to-day clinical operations activities, overseeing and executing delegated tasks to appropriate parties.

What is Clinical Trial Management System – CTMS

CTMS helps to maintain and manage the planning, performing, and reporting functions, along with participant contact information, tracking deadlines, and milestones.

This system maintains and manages the planning, performing, and reporting functions, along with participant contact information, tracking deadlines, and milestones.

Softwares In The Clinical Trial Management System:

WHAT ARE THE BEST CLINICAL TRIAL MANAGEMENT SOFTWARE IN 2022?

Roles And Responsibilities of Clinical Research Coordinator:

Key responsibilities of the CRC include the planning and management of the study, enrollment, maintenance, training initiatives, and maintaining compliance with federal, state, and institutional regulations. In addition, they carry out experiments, clinical research, and medical studies. They also engage directly with the trial participants as they screen them for eligibility, develop and implement recruitment strategies, and liaise with all teams throughout the trial. From evaluating research protocols to seeking approval from regulatory committees, CRCs have a broad reach within laboratories, medical centers, and research hospitals.

Our  Interactive-CRC training program for Clinical Research Professional are designed for persons with or without prior on-site clinical trials experience, seeking qualifications and/or current practical knowledge to effectively work as a Principal Investigator (PI), Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Data Coordinator or Clinical Data Manager (CDM) in the monitoring of clinical trials globally in all countries that follow the ICH-GCP guidelines for conducting clinical trials. All courses include ICH-GCP certification.

Prior to the start of the course, participants will receive comprehensive course material. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates.

Program Objective:

  • Describe the drug development process, the importance of Good Clinical Practice, and the roles and responsibilities of the research team
  • Define the regulatory requirements, explain the differences between ICH and FDA guidelines, and describe the elements of a protocol
  • Outline required elements of the informed consent
  • Identify the investigational product accountability requirements and impact of the reconciliation process on the study
  • Define the safety definitions and comprehend the safety reporting requirements
  • Prepare for and complete source document verification
  • Perform the steps involved in monitoring the study pre-visit, during the visit, and post-visit
  • Create cohesive, well-written protocol deviations and action items, and accurately complete the monitor visit report and site follow-up letter
  • Define the impact of quality assurance and audits in clinical research

CRC Course syllabus

  • Module 1: Drug Development Process, Good Clinical Practice (GCP), and Clinical Research Team Roles and Responsibilities
  • Module 2: IRB, Clinical Study Protocol Elements and Amendments
  • Module 3: Informed Consent
  • Module 4: Investigational Product Accountability
  • Module 5: Safety Definitions and Reporting Requirements
  • Module 6: Source Document Verification
  • Module 7: Monitoring the Study
  • Module 8 and Module 9: Monitoring Visit Reports and Contact Reports
  • Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections

Eligibility for CRC Certification Program:

  • Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
  • To secure a job as a CRC, professionals must have at least a four-year bachelor’s degree in a field such as medical technology, microbiology, or public health administration. However, some employers require an additional two-year master’s degree, particularly for management positions.

Clinical Research Associate VS Clinical Research Coordinator:

clinical research associate (CRA), also called a clinical monitor or trial monitor, is a research professional with a minimum of a bachelors degree (usually nurses!) who works under contracts or hired by sponsors, CROs, or freelancing (by biopharma and research institutes) to perform roles listed in ICH GCP guidelines for monitoring clinical trials.When a PI (principal investigator, i.e. often a busy, working physician running a trial on the side) is chosen to conduct a trial at their site, clinical research coordinators often take over part of the essential responsibilities of PI. This includes making sure the trial is 1) conducted and 2) in compliance with the protocol and federal or international regulations.

Note: Please go through ICH GCP guidelines once for CRC Interview Preparation:

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

  • A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying CRC online training material is appropriately aligned with the current Industry’s expectations.
  •  Assignments for all the programme modules for continuous evaluation and guidance.
  •  Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • CRC Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
  • All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
  • Clinical trail program Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.

Interview Preparation Sessions

Participants who have completed the Clinical Research Coordinator course training will be put under our Placement Incubation Program. As part of this program, participants will undergo a thorough CRC interview preparation process. A huge repository of Clinical Research Coordinator Interview questions with answers will be provided for the participants to prepare after CRC online Certification. A dedicated Clinical Research Coordinator Expert Trainers (SME) will help in resume building, conduct mock interviews and evaluate each participant’s knowledge, expertise and provide feedback. Clinical Research coordinator Resume Samples will be given and the participant should Update With Clinical Research coordinator Skills. Our SMEs will do the necessary handholding on Clinical Research coordinator interview preparation process till the time the participant is placed in Clinical Research Companies in Hyderabad,Pune Mumbai and Bangalore etc. Guidance is also provided on Linkedin profile building and tricks of the trade to improve the marketability of the resume. – Clin Infotech Management.

Assessment & Certification

All the participants are expected to appear online assessment . After successful completion the participants will be certified as professional in Clinical Research Coordinator (CRC) by Clin Infotech. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The CRC certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the Clin Infotech assessment process.

Placement Assistance & Corporate Relations

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

Clinical Research coordinator Companies

  • IQVIA
  • Covance
  • Parexel
  • Asiatic clinical Research
  • Astron research
  • BioAxis
  • Bioclinica
  • Axis Clinical
  • Croissance
  • Dubar Research foundation
  • Eresearch technologies
  • Global clinical Trials
  • GVK Biosciences
  • Kemwell Biopharma
  • Labcorp
  • Lambda Therapeutics
  • Makro care
  • Navitas LifeSciences
  • Novotech
  • PPD
  • Sai Life Sciences
  • Spectrum Clinical Research
  • Strides Pharma Research
  • symphony,syneos Health Care
  • Syngene,Techobserver
  • Vedic  Life sciences Etc.