Central CRA (Clinical Research Associate)- Registries

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Hiring Manager: Project Lead - ESR and Grants

Location: Hyderabad

Site Monitoring:

Off-Site Visits

Onsite (where local hub affiliates are located)

Assure adequate safety reporting process of the site, and that site is submitting and/or

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Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.

To maintain all the tables, trackers and databases updated to follow the study progress

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To know and use all the tools needed.

Participates in the investigator payment process, if applicable

To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required.

Study Meetings: To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

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People: (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business

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Performance: (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA s reports, including monitoring visit reports, progress reports,

Performance: (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA s reports, including monitoring visit reports, progress reports,

Experience :

3+ years of experience in Clinical research & development including clinical trial monitoring experiences. Rare diseases or observational studies, real world evidence experience will be a plus.

Attention to Detail: Critical for monitoring trial data and ensuring accuracy.

Problem-Solving: Ability to address and resolve issues that arise during trials.

Project Management: Skills in managing timelines, budgets, and resources.

Technical Writing: Proficiency in writing reports, protocols, and regulatory documents.

Experience in working in global projects and international matrix environment.

Communication: Excellent written and oral communication skills to interact with various stakeholders.

Adaptability: Ability to adapt to changing requirements and environments3.

Interpersonal Skills: Building and maintaining positive relationships with stakeholders3.

Time Management: Efficiently managing time and prioritizing tasks.

Ethical Judgment: Strong sense of ethics and integrity in conducting clinical research.

Good Clinical Practice (GCP): Understanding and adherence to GCP guidelines.

Regulatory Requirements: Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).

Clinical Trial Processes: Familiarity with clinical trial phases, protocols, and methodologies.

Data Management: Skills in data collection, analysis, and reporting.