Professional Excellence Program in Clinical Research (PEP-CR)

CLINICAL TRIAL MANAGEMENT JOB PROFILES

Clinical Research Coordinator (CRC):

1.     Protocol Implementation: Ensure adherence to study protocols and regulatory requirements at the study site.

2.     Participant Recruitment: Screen and enroll eligible participants according to study criteria.

3.     Informed Consent: Facilitate the informed consent process, ensuring participants understand the study risks and benefits.

4.     Data Collection: Collect and record accurate and complete study data, including medical histories and study-specific assessments.

5.     Study Documentation: Maintain regulatory documentation, including case report forms (CRFs) and investigator site files (ISFs).

6.     Study Coordination: Coordinate study visits, procedures, and follow-up activities for participants.

7.     Safety Reporting: Monitor and report adverse events (AEs) and serious adverse events (SAEs) to the appropriate regulatory authorities and study sponsors.

8.     Quality Assurance: Ensure compliance with Good Clinical Practice (GCP) guidelines and internal standard operating procedures (SOPs).

9.     Communication: Serve as the primary point of contact between the study site, investigators, sponsors, and regulatory authorities.

10. Training and Education: Provide training to study staff and investigators on study protocols, procedures, and regulatory requirements.

Clinical Research Associate (CRA):

1. Site Monitoring: Conduct routine site visits to ensure protocol compliance, data integrity, and participant safety.

2. Site Initiation: Perform site initiation visits (SIVs) to train study staff and ensure readiness for study initiation.

3. Site Closeout: Conduct site closeout visits to ensure all study activities are completed, data is accurate, and regulatory documents are archived appropriately.

4. Data Verification: Review and verify study data against source documents, ensuring accuracy and completeness.

5. Query Resolution: Generate and track data queries to resolve discrepancies or missing information in study data.

6. Regulatory Compliance: Ensure compliance with GCP, regulatory requirements, and study protocols.

7. Study Documentation: Maintain and update trial master files (TMFs) and other study documentation as per regulatory standards.

8. Risk Management: Identify and mitigate risks to study quality, participant safety, and data integrity.

9. Communication: Communicate effectively with study sites, sponsors, and other stakeholders to address study-related issues and ensure timely resolution.

10. Reporting: Prepare monitoring reports, study progress updates, and other documentation for internal and external stakeholders.

Principal Investigator (PI): If you are from a medical background then you can work as a Principal Investigator (PI). PI holds the primary responsibility for the conduct of a clinical trial at the investigative site. Their role is pivotal in ensuring the safety of participants, the integrity of data, and compliance with regulatory requirements.

CLINICAL DATA MANAGEMENT JOB PROFILES

Clinical Data Manager (CDM):

• Responsible for overseeing the collection, validation, and analysis of clinical trial data.
• Develops data management plans and ensures adherence to protocols and regulatory requirements.
• Manages data cleaning, coding, and database lock processes.
• Coordinates with study teams, vendors, and stakeholders to ensure data quality and timelines.

Clinical Database Programmer:

• Designs, develops, and maintains databases for clinical trial data
• Implements data validation checks and edit checks to ensure data accuracy and completeness.
• Generates data listings, tables, and figures (TLFs) for analysis and reporting.
• Provides technical support for database-related issues and query resolution.

Clinical Data Coordinator:

• Supports data management activities, including data entry, verification, and cleaning.
• Assists in the development of case report forms (CRFs) and data management plans.
• Performs quality control checks on data and resolves discrepancies.
• Communicates with study sites and monitors for timely data submission and query resolution.

Clinical Data Analyst:

• Analyzes and interprets clinical trial data to identify trends, patterns, and outliers.
• Conducts statistical analysis and generates summary reports for study teams.
• Participates in data review meetings and contributes to data interpretation discussions.
• Assists in the preparation of study manuscripts and presentations.

Clinical Quality Assurance Specialist:

• Conducts quality assurance audits to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Reviews study documentation, data management processes, and study conduct for adherence to protocols.
• Provides recommendations for process improvements and corrective actions.
• Assists in the preparation for regulatory inspections and audits.

Principal Investigator (PI)

• Protocol Development: The PI may contribute to the development of the study protocol, ensuring it aligns with ethical principles, regulatory guidelines, and scientific validity.
• Study Site Selection: The PI selects and evaluates potential study sites, ensuring they have the necessary infrastructure, resources, and expertise to conduct the trial effectively.
• Participant Recruitment and Informed Consent: The PI oversees participant recruitment efforts, ensuring adherence to eligibility criteria and ethical standards. They are responsible for obtaining informed consent from participants or ensuring delegated staff members do so.
• Study Conduct: The PI is responsible for the overall conduct of the study at the investigative site, including oversight of study procedures, participant care, and data collection.
• Safety Monitoring: The PI monitors participant safety throughout the trial, promptly reporting adverse events (AEs) and serious adverse events (SAEs) to regulatory authorities and the sponsor.
• Data Collection and Management: The PI ensures accurate and complete collection of study data, including adherence to data entry procedures and timely completion of case report forms (CRFs).
• Regulatory Compliance: The PI ensures compliance with Good Clinical Practice (GCP) guidelines, local regulations, and institutional policies throughout the trial.
• Investigational Product Management: If applicable, the PI is responsible for the handling, storage, dispensing, and accountability of investigational products according to protocol requirements.
• Site Monitoring and Audits: The PI may interact with clinical research associates (CRAs) during site monitoring visits and assist with audits and inspections conducted by regulatory authorities or sponsors.
• Study Closeout: The PI ensures that all study-related activities are completed according to the protocol and regulatory requirements, facilitating the timely submission of study documents for closeout.

PHARMACOVIGILANCE JOB PROFILES:

Pharmacovigilance Specialist:

• Collects, evaluates, and reports adverse drug reactions (ADRs) and adverse events (AEs) from healthcare professionals, patients, and literature sources.
• Conducts case processing activities, including data entry, coding, and narrative writing.
• Performs medical review of individual case safety reports (ICSRs) to assess causality and seriousness.

Drug Safety Associate:

• Assists in the collection, processing, and reporting of adverse events and safety data.
• Conducts initial triage and assessment of ICSRs for completeness and accuracy.
• Supports medical review activities and assists in signal detection and risk management tasks.

Pharmacovigilance Manager:

• Oversees pharmacovigilance operations and staff, ensuring compliance with regulatory requirements and company policies.
• Manages the processing, assessment, and reporting of adverse events in accordance with global pharmacovigilance regulations.
• Provides leadership and guidance on pharmacovigilance processes, risk management, and safety surveillance activities.

Pharmacovigilance Physician:

• Provides medical expertise in the evaluation and assessment of adverse events and safety signals.
• Conducts medical review of individual case safety reports (ICSRs) to determine causality, seriousness, and expectedness..
• Supports risk management activities, including safety assessments, signal detection, and risk minimization strategies.

Pharmacovigilance Scientist:

• Conducts signal detection and data analysis activities to identify potential safety concerns and emerging risks.
• Performs literature review and analysis to gather safety-related information and evidence.
• Collaborates with cross-functional teams to assess and mitigate safety risks throughout the product lifecycle.

Regulatory Affairs Specialist:

• Ensures compliance with pharmacovigilance regulations and guidelines, including reporting requirements and submissions to regulatory authorities.
• Supports the preparation and submission of periodic safety reports (PSURs), risk management plans (RMPs), and other regulatory documents.
• Provides regulatory guidance on pharmacovigilance-related issues and assists in regulatory inspections and audits.

Quality Assurance Specialist:

• Conducts audits and inspections to evaluate compliance with pharmacovigilance regulations, standard operating procedures (SOPs), and quality standards.
• Reviews pharmacovigilance processes, procedures, and documentation for adherence to regulatory requirements.
• Provides recommendations for process improvements and corrective actions to ensure data integrity and patient safety.