7 Regional Cancer Centre jobs in Thiruvananthapuram

Job Role : Clinical Research Associate - Study Personnel (Toxicology & Efficacy)

Location: Dholka, Gujarat

Job Responsibilities :

1. Request for required no. of animals

2. Observe the study animals for clinical signs, functional observation battery and

mortality

3. Receipt, storage and handling of chemicals, reagents and solutions

4. Dose preparation and dosing of animals via different routs

5. Weighing of animals, feed consumption, body temperature, dermal observations

6. Randomization of study animals

7. Perform pharma-efficacy studies like batch release test i.e., Pyrogen test, Abnormal

toxicity test, Potency assays, nodule test etc.

8. Blood collection, separation and storage of samples

9. Preparation of study reports

10. Conduct of study, data collection, compilation and verification.

11. Collection of sample(s) / Specimen(s).

12. Preparation and verification of report.

13. To participate in Genotoxicity study

14. Data entry from raw data to computer application and further analysis

15. Co-operate during internal, RQA & sponsor audits of study plans, studies, data,

reports etc.

16. To participate in standardization of new toxicity study

17. Ensure proper labeling of containers (test item, samples etc.)

Documentation:

1. To document deviation from SOP or study plan and communicate directly with SD.

2. Recording raw data promptly and accurately and in compliance with Principles of

GLP.

3. Maintenance of internal records as per in-house SOPs and GLP

4. Update and maintain training records

5. Ensuring the availability of various monitoring certificates such as feed, water,

bedding material, health etc.

6. Request for the issuance of controlled / uncontrolled document and maintain the

documentation

7. Prepare / revise the SOPs as and when required in accordance with in-house SOP

8. Archive the documents as per in-house SOPs when applicable

9. Document the deviation from study plan or SOP and report the incident to SD or

HOS.

10. Record the raw data as and when activities are performed, verify the data and

calculation.

11. Results compilation and analysis

Instrument handling and maintenance:

1. Operate the instruments in accordance with respective instrument SOP, monitor

calibration & maintenance of instrumentation in lab

2. Perform the calibration / maintenance of instruments as per in-house SOP

• Plan, implement, and manage clinical trial activities at assigned sites.
• Monitor clinical trial progress, ensuring data integrity, accuracy, and patient safety.
• Verify that investigational product is handled, administered, and accounted for correctly.
• Conduct site visits (initiation, monitoring, close-out) according to study requirements and standard operating procedures (SOPs).
• Ensure compliance with study protocols, FDA regulations, ICH-GCP guidelines, and other applicable regulatory requirements.
• Train and support study site staff on protocol requirements, study procedures, and data collection.
• Resolve site-level issues and escalate critical issues to the clinical project manager as needed.
• Manage essential study documents and ensure their accurate and timely submission.
• Communicate effectively with investigators, site staff, and internal project teams.
• Prepare and present study progress reports.
• Contribute to the development of study protocols, informed consent forms, and other study documents.
• Ensure timely query resolution and data cleaning at study sites.
• Maintain proactive communication channels with study sites and internal stakeholders.
• Oversee the recruitment and retention of study participants.
• Manage site budgets and expenses related to clinical trial activities.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline. Master's degree preferred.
• Minimum of 4 years of experience as a Clinical Research Associate or equivalent role in clinical trial management.
• Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Experience in therapeutic areas such as (mention relevant areas, e.g., oncology, cardiology, neurology) is highly desirable.
• Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, time management, and multitasking skills.
• Strong analytical and problem-solving abilities.
• Exceptional communication, interpersonal, and presentation skills.
• Ability to travel to clinical sites as required (approximately 50-60% travel).
• Attention to detail and commitment to data accuracy and patient safety.
• Ability to work independently and effectively within a hybrid work environment.
• Certification from recognized clinical research organizations is a plus.

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Minimum 5 years of experience as a Clinical Research Associate.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Proven experience in conducting site monitoring visits (IMVs, PMVs, SIVs, COVs).
• Familiarity with clinical trial phases and study design.
• Experience with EDC and CTMS systems.
• Excellent communication, interpersonal, and organizational skills.
• Ability to manage multiple studies and sites simultaneously.
• Strong problem-solving and decision-making abilities.
• Willingness to travel frequently to clinical trial sites.
• Detail-oriented with a focus on data accuracy and integrity.

• Conduct site visits (pre-study, initiation, monitoring, and close-out) to assess study conduct and regulatory compliance.
• Verify the accuracy, completeness, and validity of clinical trial data.
• Ensure that the clinical trial is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
• Monitor patient safety and report adverse events promptly.
• Review and reconcile essential study documents at clinical sites.
• Provide training and ongoing support to site staff on study-specific procedures.
• Prepare monitoring visit reports and follow up on action items.
• Collaborate with investigators, site staff, and internal study teams to resolve issues.
• Ensure timely submission of study-related documents to regulatory authorities.
• Maintain effective communication channels with all stakeholders involved in the clinical trial.

• Bachelor's degree in a life science, nursing, or a related field. Advanced degree preferred.
• Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Experience with clinical trial monitoring tools and electronic data capture (EDC) systems.
• Excellent organizational, analytical, and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to travel to clinical sites as required (estimated X% travel).
• Proficiency in Microsoft Office Suite.
• Ability to work effectively in both remote and on-site settings.
• Certification from a recognized organization (e.g., ACRP, SOCRA) is a plus.

• Deliver projects in digital transformation initiatives, including cloud technologies, AI, and automation.
• Collaborate with teams and clients to define long-term vision, goals, and strategies.
• Implement problem-solving procedures to enhance efficiency in resolving customer issues.
• Create and implement strategies and solutions to maximize customer satisfaction.
• Deep understanding of Pharma Value Chain, regulatory requirements and compliance standards.
• Ability to manage change effectively and drive adoption of new solutions.
• Collaborate with cross-functional teams to ensure seamless project execution.
• Lead and motivate teams to achieve project objectives.
• Develop data-driven solutions to address business challenges
• Clearly articulate and document business requirements, functional specifications, and user stories.
• Develop detailed process flows and diagrams to visualize business processes and system workflows.
• Collaborate with technical teams to create technical documentation, such as system design documents etc
• Clearly communicate complex technical concepts to both technical and non-technical audiences.
• Develop and deliver engaging presentations that captivate the audience and convey key messages.

Primary Skills:

• 3-6 years of experience in management consulting or relevant roles within the life sciences industry.
• Comprehensive understanding of life sciences industry Clinical Databases like CDD Vault, Dotmatics,Revvity, IDBS and more
• Knowledge of Ontologies and Data-catalog of Clinical Research Databases
• Understanding of Databases and ETL development process
• Analytical Problem-Solving: Decode complex business challenges and propose effective solutions.
• Conduct in-depth business analysis to identify opportunities for improvement and innovation.
• Gather and analyze requirements from stakeholders.
• Develop detailed functional and non-functional requirements.
• Create process flows, data flows, and other relevant documentation.
• Lead and manage complex projects across various life sciences domains.
• Define project scope, timelines, and resource allocation.
• Oversee project execution, monitor progress, and identify potential risks.
• Ensure adherence to project timelines, budgets, and quality standards.
• Deep understanding on the scrum methodology
• Hands-on experience with Google Workspace (Google Docs, Google Slides) and Microsoft Office Suite (Excel, Word).
• Familiar with ticketing systems like ServiceNow, Jira, Azure DevOps, etc.