Catalyst Clinical Services Hiring For Clinical Research Coordinator (CRC)
Position Name: Clinical Research Coordinator (CRC)
Organization: Catalyst Clinical Services
Qualification: Bachelor's or Master's degree in Pharmacy or Life Sciences; Professional Diploma in Clinical Research (PDCR) preferred
Experience: 1 Year
Salary: ₹3,00,000 - ₹5,00,000 Per Annum
Location: New Delhi, India
Email: careers@catalystclinicalservices.con
Responsibilities
- Lead end-to-end coordination of clinical trial activities at assigned investigative sites.
- Prepare and submit regulatory documents in compliance with ICH-GCP, NDCT Rules, and local ethics committees.
- Facilitate site initiation visits, ensuring all study-specific documentation is complete and accurate.
- Monitor patient recruitment, screening, enrollment, and retention to meet study timelines.
- Schedule and conduct routine site monitoring visits, documenting findings and corrective actions.
- Maintain source documents and ensure proper archiving according to SOPs and regulatory requirements.
- Coordinate the collection, verification, and transfer of case report forms (CRFs) and electronic data capture (EDC) entries.
- Track investigational product (IP) accountability, storage conditions, and dispensing logs.
- Manage adverse event (AE) and serious adverse event (SAE) reporting to sponsors and ethics committees.
- Ensure timely resolution of data queries and discrepancies identified during monitoring.
- Collaborate with principal investigators, sub-investigators, and study nurses to resolve protocol-related issues.
- Prepare study progress reports, enrollment status updates, and site performance metrics for sponsor review.
- Conduct training sessions for site staff on protocol specifics, GCP, and study procedures.
- Assist in budgeting, invoicing, and financial reconciliation for site-related expenses.
- Maintain communication logs with sites, sponsors, CROs, and internal stakeholders.
- Support the preparation of study newsletters, newsletters, and other sponsor communications.
- Ensure compliance with confidentiality and data protection regulations throughout the study lifecycle.
- Participate in risk-based monitoring strategies and implement mitigation plans as required.
- Coordinate shipment and receipt of study supplies, including temperature-sensitive materials.
- Review and approve site documentation such as informed consent forms, delegation logs, and training records.
- Track and report study milestones, including first patient screened, first patient dosed, and database lock.
- Assist in the preparation of regulatory submissions for study amendments and extensions.
- Conduct periodic audits of site files to ensure readiness for sponsor or regulatory inspections.
- Provide mentorship to junior coordinators and interns, fostering a culture of continuous learning.
- Maintain up-to-date knowledge of evolving clinical research regulations and industry best practices.
- Facilitate resolution of protocol deviations and ensure proper documentation and reporting.
- Support the creation and maintenance of study-specific SOPs and work instructions.
- Collaborate with cross-functional teams including data management, biostatistics, and medical writing.
Skills
- ICH-GCP compliance
- NDCT regulatory knowledge
- Clinical trial monitoring
- Patient recruitment and retention
- Informed consent process
- Adverse event reporting
- Investigator site management
- Electronic Data Capture (EDC) systems
- Case Report Form (CRF) handling
- Investigational product accountability
- Protocol deviation management
- Regulatory document preparation
- Ethics committee liaison
- Risk-based monitoring
- Data query resolution
- Study budgeting and invoicing
- Site training and mentorship
- Medical terminology
- Good documentation practices
- Timeline and milestone tracking
- Cross-functional collaboration
- Quality assurance audits
- SOP development and implementation
- Clinical trial logistics
- Cold chain management
- Patient safety monitoring
- Statistical analysis basics
- Pharmacovigilance fundamentals
- Effective communication skills
- Problem-solving and decision making
Company Overview
Catalyst Clinical Services is a leading contract research organization (CRO) headquartered in New Delhi, specializing in end-to-end clinical trial management for pharmaceutical and biotechnology companies. With a robust portfolio spanning Phase I to Phase IV studies, Catalyst delivers high-quality data through rigorous adherence to ICH-GCP, NDCT regulations, and ethical standards. The company boasts a strong market presence across India and emerging markets, partnering with global sponsors to accelerate drug development pipelines. Employees benefit from structured career growth pathways, continuous learning programs, and exposure to diverse therapeutic areas such as oncology, cardiology, and rare diseases. Catalyst's reputation for scientific excellence, regulatory expertise, and patient-centric approach makes it a preferred employer for aspiring clinical research professionals seeking impactful careers in the life sciences industry.
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Common Interview Questions for Clinical Research Coordinator (CRC)
Prepare for your interview by reviewing these frequently asked questions. Click on a question to reveal the answer.
Can you describe your understanding of ICH-GCP and how you apply it in daily clinical trial activities?
ICH-GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. I apply it by ensuring informed consent is obtained, maintaining accurate source documentation, conducting monitoring visits according to the monitoring plan, reporting adverse events promptly, and safeguarding participant confidentiality throughout the study.
How do you ensure compliance with NDCT Rules during a multi-center study in India?
I stay updated with the latest NDCT guidelines, verify that each site has a valid ethics committee approval, ensure the trial is registered with the Clinical Trials Registry - India (CTRI), and maintain a compliance checklist that tracks documentation, safety reporting, and amendment submissions for each site.
What steps do you take to recruit and retain patients for a clinical trial?
I develop a recruitment plan based on the target population, collaborate with site physicians to identify eligible patients, use community outreach and digital platforms, provide clear information about study benefits and risks, and maintain regular follow‑up calls to address concerns, thereby improving retention.
Explain the process of handling an adverse event (AE) and serious adverse event (SAE) at the site level.
When an AE occurs, I document it in the source file, assess severity and causality, and report it in the eCRF within the required timeframe. For an SAE, I notify the sponsor and ethics committee within 24 hours, complete the SAE form, and ensure follow‑up information is provided until resolution.
Describe how you manage investigational product (IP) accountability and storage requirements.
I maintain a detailed IP ledger, perform temperature checks daily, ensure proper labeling, reconcile dispensed doses with the accountability log, and store the product according to manufacturer specifications, documenting any deviations immediately.
What strategies do you use to resolve data queries raised by the sponsor or CRO?
I review the source documents to verify the data point, provide a clear explanation or correction in the query response, and communicate with the site staff to prevent recurrence. I also track query resolution times to meet sponsor expectations.
How do you prepare for a site initiation visit (SIV) and what documents are essential?
I compile the study protocol, investigator brochure, informed consent forms, regulatory approvals, delegation logs, and training certificates. I conduct a pre‑visit checklist, ensure the site staff are trained on study procedures, and verify that the site has the necessary equipment and IP storage facilities.
Can you discuss a time when you identified a protocol deviation and how you handled it?
During a monitoring visit, I noticed a participant was enrolled outside the inclusion criteria. I documented the deviation, informed the principal investigator, reported it to the sponsor, and implemented corrective actions, including retraining staff and updating the screening log to prevent future occurrences.
What is your approach to maintaining accurate source documentation?
I ensure that all source documents are contemporaneous, legible, and signed by authorized personnel. I conduct regular internal audits, cross‑check entries against the eCRF, and train site staff on Good Documentation Practices to maintain data integrity.
How do you handle study budget and invoicing for site-related expenses?
I review the study budget, track site expenses such as patient reimbursements and lab tests, verify supporting documents, and submit accurate invoices to the sponsor or CRO on a monthly basis, ensuring alignment with the contractual terms.
Explain the importance of risk‑based monitoring and how you implement it.
Risk‑based monitoring focuses resources on critical data and processes that impact patient safety and data quality. I assess risk factors, develop a monitoring plan that includes targeted on‑site visits and remote monitoring, and adjust the frequency based on site performance metrics.
What tools or software have you used for electronic data capture (EDC) and trial management?
I have worked with Medidata Rave, Oracle Clinical, and Veeva Vault for EDC, as well as CTMS platforms like Veeva and MasterControl for trial management, ensuring data entry accuracy and real‑time monitoring.
How do you ensure patient confidentiality and data protection throughout a study?
I de‑identify patient data, store records in locked cabinets or secure servers, limit access to authorized personnel, and follow GDPR and Indian data protection guidelines for handling personal health information.
Describe your experience with preparing regulatory submissions for study amendments.
I compile amendment documents, update the protocol and informed consent forms, obtain ethics committee approval, submit the amendment to the regulatory authority, and track the approval status to ensure timely implementation at the site.
What steps do you take to ensure proper training of site staff on a new protocol?
I organize training sessions covering protocol objectives, inclusion/exclusion criteria, safety reporting, and eCRF navigation, provide training materials, conduct competency assessments, and maintain training logs for audit readiness.
How do you manage multiple studies simultaneously without compromising quality?
I prioritize tasks based on study timelines, use project management tools to track deliverables, maintain separate documentation folders, and schedule regular check‑ins with each site to monitor progress and address issues promptly.
Explain the process of preparing a study progress report for the sponsor.
I gather enrollment numbers, site performance metrics, query resolution status, safety reports, and any deviations. I compile this data into a concise report, include visual dashboards, and submit it according to the sponsor’s reporting schedule.
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