CCRPS provides accredited and clinical research training programs and certifications to professionals from varied larger organizations. The institute’s updated Advanced Medical Monitor Certification (AMMC) course is designed for MBBS, MD, IMG, and FMG to get the best clinical research jobs in the clinical trial industry. This course has 107 modules and can be completed within 2 weeks, and will help the individuals to start their career as the Medical Monitor.
According to the spoke person at CCRPS, “Our on-demand clinical research training programs assure the compliance in education for the clinical research coordinator, clinical associates/monitors, ICH GCP, research assistants, drug safety/Pharmacovigilance officers, etc. We include training for these professionals and individuals to get clinical research certifications, Medical Monitor Certification, Pharmacovigilance and Argus Safety Certification, and Clinical Research Coordinator Certification. Our updated Advanced Pharmacovigilance and Argus Safety Certification Course will be provided to the researchers for the drug safety training.”
CCRPS provides customized training durations, CE Credits, internationally accredited certifications, and integration of the SOPs/MOPs to complete the certifications modules. The AMMC course is quite affordable without any hidden fee. The certification cost will cover all the required material provided for lifetime access and the certification exam. Furthermore, the firm facilitates paying the course fee up to four installments.
The institute offers lifetime online access to the course materials. The course is completely flexible, and professionals can schedule it as per their availability without worrying about due dates. Moreover, the company also offers a recommendation letter and internationally accredited certificate to complete 52 questions tests. The certificate will be valid for ten years.
Accreditation Council for Pharmacy Education (ACPE), Accreditation Council for Clinical Research & Education (ACCRE), along with the American Medical Association (AMA), and American Nurses Credentialing Center (ANCC) accredit the courses provided by CCRPS. The company offers 17.5 CME credits through AMA & Joint Commission.
The advanced AMMC course by CCRPS will help the medical monitors get experience in drug safety training and become key leaders in providing the opinion for the medical trials. Professionals can visit https://app.ccrps.org/courses/medial-monitor-certification to register the course or for more details.
Medical Monitor Job Role Example:
Duties and Responsibilities:
- Design protocol strategy and assist with development of regulatory and study documents:
- Design a clinical study to meet the agreed strategic context.
- Leads study team in writing the synopsis and background section of the protocol.
- Finalize protocols and amendment.
- Approve study template informed consent form (ICF).
- Coordinate with the study team to review and approve study processes and deliverables.
- Participates in development of CRF, statistical analysis plan (SAP), DMC charter and other documents as required by the OCD.
- Responsible for study conduct in conjunction with clinical operations:
- Participate in study management team meetings, Data Monitoring Committee (DMC) and steering committees as required.
- Answer safety questions and review the literature as needed, provide input to safety issues and answer questions posed by IRB, IBC, DMC, etc.
- Actively interact with investigative sites, respond to protocol/medical questions.
- Provide communication(s) to sites across the stud.
- Assist sites with subject evaluation and protocol adherence.
- Review safety reports to support regulatory notifications and filings.
- Participate in vendor selection for IRB, DMC and other outsourcing activities.
- Study Level Data Review:
- Perform review of data generated by data listings or statistical analyses.
- Request additional tables or analyses where appropriate.
- Review individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities.
- Participate in all reviews and procedures required for database lock.
- Review all patient narratives.
- Review outstanding medical or GCP issues report and address issues across the study.
- Provide Study team with medical expertise during key activities:
- Answer medical and inclusion/exclusion questions.
- Issue resolution.
- Audit response.
- Study closeout/inspection readiness.
- Oversee and conduct protocol training; produce relevant and materials:
- Deliver protocol training during Investigator meeting and Site Initiation Visit (SIVs).
- Create medical training materials for SIVs and study team training.
- Provide specific medical/protocol training for Clinical Research Associates (CRAs) and study team.
- Develop medical/protocol training for use during Site Initiation Visit (SIV).
- Be available to answer questions specific to the protocol during the site start-up process.
- Participate in safety evaluation and support for the investigational products:
- In conjunction with the drug safety team, answer medical/safety questions and resolve medical/safety issues from sites, CRAs and study team; such as questions from sites on protocols. In conjunction with other medical personnel, ensure answers are consistent across all sites and studies.
- Participate or lead safety issue workups.
- Review study and individual subject safety for assigned studies and present findings at quarterly drug safety reviews.
- Interact with regulatory groups and internal auditing groups on a study level:
- DMC Interaction.
- Accountable for providing a response to regulatory agency inspection observations and internal audits.
- Support regulatory update.
- Assists with rest of world regulatory activities to support study conduct and future marketing approval strategy and execution.
- Contribute to, review, and edit Clinical Study Reports (CSR).Contributes to IB updates for the project:
- Approve patient narratives.
- Conduct decision point preparation for senior management.
- Assists in development of scientific meeting abstracts and presentations as well as manuscripts.
- BLA submission team. Performs other duties as required:
- Member of the team with specific responsibilities including CSR as well as summary documents which may be assigned.
- Assists in oversight of other BLA requirements such as clinical pharmacology requirements for the drug.
- M.D. degree or equivalent with + years’ experience in clinical trials and drug development.
- Clinical research experience in a pharmaceutical or CRO environment a plus.
- Demonstrated experience conducting of clinical studies supporting cancer research.
- Experience interacting with FDA.
CCRPS is an online training program for individuals and professionals to become experienced Clinical Research Coordinators, Medical Monitors, and Associates to excel in their fields.
For more details on cost and their certification programs, email them at support@CCRPS.org.
Company Name: CCRPS
Contact Person: M.K.
Email: Send Email
Country: United States