Welcome to the "MARCHING AHEAD" a comprehensive workshop-based training program designed to empower Clinical Research Associates (CRAs) in their roles as monitors for regular phase clinical trials as well as Real-World Evidence (RWE) studies. This training aims to enhance their skills and abilities, enabling them to handle their responsibilities more effectively in the workplace. Whether you are an experienced CRA or a fresher, this program will equip you with the necessary knowledge and expertise to excel in your role.
Role Of CRA In Clinical Trials
Clinical Research Associates (CRAs) play a crucial role in ensuring the success and safety of clinical trials. They are responsible for monitoring the progress of trials at investigative sites, verifying data accuracy, and ensuring compliance with protocols, regulations, and guidelines. CRAs act as a bridge between sponsors, investigators, and regulatory authorities, making them essential to the clinical trial process.
CRAs face various challenges during their monitoring activities. Some of these challenges include:
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Site Management: Ensuring sites are adequately prepared, adhering to protocols, and maintaining proper documentation.
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Communication: Effective communication with investigators, study coordinators, and other stakeholders is vital for the success of the trial.
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Decision-Making: CRAs must make critical decisions related to data quality and patient safety, often under time constraints.
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Negotiation: Negotiating with site personnel and resolving issues diplomatically to maintain trial integrity.
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Crisis Management: Handling unexpected situations and emergencies that may arise during the trial.
The Need For "Marching Ahead" Training
The "MARCHING AHEAD" training program addresses the challenges faced by CRAs during
monitoring and provides practical solutions to overcome them. This training is essential because it
Enhances Monitoring Skills
The program strengthens clinical trial monitoring fundamentals and site management skills, improving overall efficiency.
Protocol Adherence
Participants learn the importance of protocol adherence and how to ensure compliance ffectively.
Effective Communication
CRAs gain valuable communication skills, enabling better interactions with stakeholders.
Decision-Making & Crisis Management
The training equips participants to make informed decisions, de-escalate issues and handle crises confidently.
Empowerment
Continuously improves its analytical capabilities, providing increasingly valuable insights over time.
Key Challenges Faced By
CRAs During Monitoring
Advantages Of The Training
Real-Life Examples
"MARCHING AHEAD" uses real-life case studies and examples to help participants relate directly to their work.
Tailored for Experience Levels
The program is ideal for participants with at least 2 – 3 years of experience, but can be customized for any experience levels, ensuring relevant and impactful learning.
Soft Skills Development
Participants enhance soft skills, such as effective communication, business etiquettes, negotiation, conflict resolution, and time management, for career growth.
Comprehensive Coverage
The training covers various aspects, from site selection to site close-out, from informed consent to audits and inspections, from source data verification to eTMF management, making it a holistic learning experience.
Expert Trainers
The program is led by experienced trainers with extensive expertise in clinical research, clinical trial operations, project management, and communication.
Key Aspects Of The Training
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Duration:
The training is a 3-day program, which can be further customized into a 2-day format if required.
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Interactive Learning:
The training includes role plays, experience sharing, case studies, presentations, videos, and team activities.
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Training Mode:
The program can be conducted face-to-face with groups of up to 15-25 participants or as virtual instructor-led training.
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Ready-Reckoner:
Participants receive a one-page overview of lessons learned after each session
for quick reference.
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Assessments & Feedback:
Pre- and post-training assessments are conducted, and feedback is sought from participants for continuous improvement. ROI to the organization and impact of the training program at the participant/group/organization levels can also be analysed upon request.
Topics Covered In The Training
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Introduction and Goal Setting
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Informed Consent Process and Challenges
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Safety Monitoring and Adverse Events
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Source Documents and Source Data
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Investigational Medicinal Products and Vendors
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Data Management and Query Resolution
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Investigator Site File and Trial Master File
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Site Evaluation, Initiation, and Close-out Visits
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Site Visit Report Writing Skills
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Time Management during Site Visits
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Managing Difficult Conversations and Negotiations
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Handling Crisis and Stakeholder Management
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Audits and Inspections
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Wrap-up Session and Additional Discussions
Contact us today for the "MARCHING AHEAD" training program and unlock your full potential as a Clinical Research Associate. Take the next step in your monitoring journey and be prepared to MARCH AHEAD with confidence!