Senior Clinical Research Associate - Oncology
Posted today
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Job Description
The ideal candidate will possess extensive experience in clinical research, with a strong focus on oncology. You will conduct site visits to verify data accuracy, assess patient safety, and ensure adherence to study protocols. Excellent communication and interpersonal skills are essential for building strong working relationships with investigators, site staff, and internal project teams. This role requires meticulous attention to detail, a thorough understanding of regulatory guidelines (e.g., FDA, EMA), and the ability to manage multiple study sites effectively.
Key responsibilities include training site personnel on study procedures, managing study supplies, and ensuring timely submission of regulatory documents. You will also be involved in problem-solving at the site level, identifying and resolving issues that may impact study progress or data integrity. This position offers a challenging and rewarding opportunity to contribute to the development of life-saving cancer therapies and advance patient care. A proactive approach to quality assurance and a commitment to ethical research practices are paramount.
Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits for clinical trials.
- Ensure compliance with study protocols, SOPs, and regulatory requirements (GCP, FDA, EMA).
- Verify the accuracy and completeness of clinical data at study sites.
- Assess patient safety and ensure adherence to ethical standards.
- Train and support investigators and study staff on trial procedures.
- Manage study documentation and regulatory binders.
- Identify, track, and resolve site-specific issues and deviations.
- Communicate effectively with study sites, internal teams, and sponsors.
- Prepare and present monitoring visit reports.
- Contribute to the development of study protocols and CRFs as needed.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
- In-depth knowledge of GCP, FDA regulations, and ICH guidelines.
- Proven experience in site monitoring and data verification.
- Excellent analytical, organizational, and problem-solving skills.
- Strong communication, interpersonal, and negotiation abilities.
- Ability to travel to study sites as required.
- Experience with electronic data capture (EDC) systems.
Senior Clinical Research Associate - Oncology
Posted 3 days ago
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Job Description
Key Responsibilities:
- Conduct pre-study, initiation, interim, and close-out monitoring visits for clinical trial sites.
- Ensure adherence to study protocols, GCP, ICH guidelines, and applicable regulations.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Manage and monitor study site activities, including patient recruitment and retention.
- Ensure timely reporting and documentation of adverse events and safety information.
- Serve as the primary point of contact for study sites, addressing questions and issues.
- Provide training and ongoing support to site staff.
- Review and approve essential regulatory documents.
- Contribute to the development of clinical trial protocols and monitoring plans.
- Maintain effective communication with study teams, investigators, and internal stakeholders.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or related discipline.
- 5+ years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research.
- Proven experience in site monitoring, data management, and regulatory compliance.
- Strong understanding of oncology indications, treatment modalities, and drug development processes.
- Excellent interpersonal, communication, and organizational skills.
- Ability to travel to study sites as required (though the role is remote).
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to work independently and manage time effectively in a remote setting.
- Detail-oriented with a strong commitment to quality and patient safety.
Senior Clinical Research Associate - Oncology
Posted 5 days ago
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Job Description
Key Responsibilities:
- Conduct pre-study, initiation, routine, and close-out monitoring visits for assigned clinical trial sites.
- Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols.
- Verify the accuracy, completeness, and integrity of clinical data.
- Manage and mentor junior CRAs and study site personnel.
- Prepare comprehensive monitoring visit reports and follow up on action items.
- Identify and report adverse events and protocol deviations.
- Collaborate with cross-functional teams, including data management, regulatory affairs, and project management.
- Contribute to the development and review of study-related documents.
- Maintain accurate and up-to-date study documentation.
- Act as a primary point of contact for assigned sites and investigators.
Qualifications:
- Bachelor's or Master's degree in a life science, nursing, or related field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
- Extensive knowledge of ICH-GCP guidelines and regulatory requirements (e.g., FDA, EMA, CDSCO).
- Strong understanding of oncology disease states and treatment modalities.
- Exceptional organizational and time management skills.
- Excellent written and verbal communication abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and manage multiple priorities in a remote setting.
- Demonstrated ability to build and maintain strong relationships with clinical sites.
Senior Clinical Research Associate - Oncology
Posted 17 days ago
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Job Description
As a Senior CRA, you will be responsible for managing and monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. You will act as the primary point of contact for study sites, providing training and support to site staff, and ensuring accurate and timely data collection. This position demands a deep understanding of oncology drug development, clinical trial conduct, and regulatory affairs. The ideal candidate will possess strong analytical skills, excellent organizational abilities, and a commitment to ethical research practices.
Key Responsibilities:
- Monitor assigned clinical trial sites to ensure adherence to study protocols, SOPs, and regulatory guidelines (GCP, FDA, EMA).
- Perform site initiation, interim monitoring, and close-out visits.
- Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
- Manage site-level recruitment efforts and ensure timely subject enrollment.
- Provide training and ongoing support to site investigators and study coordinators.
- Build and maintain strong relationships with site personnel and key opinion leaders.
- Identify, assess, and resolve site-specific issues and deviations.
- Ensure timely submission of all required regulatory documents and reports.
- Track study progress and report on key performance indicators to study management teams.
- Contribute to the development of study protocols, case report forms (CRFs), and monitoring plans.
- Maintain accurate and up-to-date site files and documentation.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with a strong focus on Oncology clinical trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trial sites and managing data integrity.
- Excellent understanding of oncology drug development processes and therapeutic areas.
- Strong communication, interpersonal, and negotiation skills.
- Ability to travel frequently to clinical trial sites (up to 60%).
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Detail-oriented with strong analytical and problem-solving capabilities.
- Ability to work independently and manage time effectively in a hybrid work environment.
Clinical Research Associate (CRA) - Oncology
Posted 17 days ago
Job Viewed
Job Description
- Conduct site initiation visits, routine monitoring visits, and close-out visits at clinical trial sites to ensure adherence to the study protocol, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure patient safety and rights are protected throughout the clinical trial process.
- Manage and maintain effective communication with investigators, site staff, and study sponsors.
- Oversee the regulatory compliance of study sites, including essential document review and audit preparation.
- Identify, track, and resolve study-related issues and deviations in a timely manner.
- Train site personnel on study protocols, procedures, and data collection requirements.
- Prepare and submit monitoring visit reports promptly and accurately.
- Contribute to the development and review of study-related documents, such as protocols and informed consent forms.
- Ensure timely drug accountability and management at study sites.
- Stay current with advancements in oncology research and clinical trial methodologies.
- Collaborate with internal teams, including data management, medical affairs, and project management.
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or a related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA), with a significant focus on oncology trials.
- Thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements.
- Proven experience in monitoring clinical trial sites and managing data integrity.
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities, with meticulous attention to detail.
- Ability to travel to clinical trial sites as required (approximately 50-70% travel).
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Problem-solving skills and the ability to work independently and as part of a team.
Research Scientist - Oncology
Posted 15 days ago
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Job Description
Key Responsibilities:
- Conduct independent research to identify and validate novel oncology targets.
- Design, perform, and interpret complex in vitro and in vivo experiments to assess drug efficacy and mechanism of action.
- Analyze and interpret large datasets using advanced bioinformatics tools and statistical methods.
- Develop and optimize cell-based assays and biochemical assays relevant to oncology.
- Collaborate closely with computational biologists, medicinal chemists, and pharmacologists.
- Prepare and present research findings at internal meetings and external scientific conferences.
- Contribute to the writing of grant proposals, manuscripts for publication, and regulatory submissions.
- Stay current with the latest scientific literature and technological advancements in oncology drug discovery.
- Mentor junior research staff and contribute to a positive and collaborative research environment.
- Troubleshoot experimental challenges and propose innovative solutions.
Medical Science Liaison- Oncology
Posted today
Job Viewed
Job Description
Domnic Lewis has been mandated to hire for a Medical Science Liaison – Oncology role with a Global Pharma MNC.
Position: Medical Science Liaison – Oncology
Location: Kolkata & Bangalore
Qualification: MBBS/ MD Pharmacology/ PhD with extensive experience in Oncology
Experience: 0-5yr
Travel: Approximately 70% of the time
Role Purpose:
Build and strengthen medical affairs presence in oncology by engaging key stakeholders, supporting research, and sharing scientific insights on hard-to-treat cancers. Field-based role covering India.
Key Responsibilities:
- Engage with KOLs, hospitals, and institutions to share fair and balanced medical information.
- Support company-sponsored studies, IITs, registries, and RWE projects.
- Provide medical expertise and field insights to internal teams.
- Collaborate with sales, market access, and other functions to execute regional medical plans.
- Ensure compliance with regulations and support patient awareness/PSP initiatives.
Profile:
- MBBS/MD/PhD with 1–2 years of oncology experience.
- Strong communication, stakeholder management, and scientific knowledge.
- Ability to work cross-functionally with integrity and business acumen.
- Proficient in English.
Note: Only candidates with relevant experience and qualification will be contacted.
Interested candidates can reach out to to expedite the process.
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Medical Science Liaison- Oncology
Posted today
Job Viewed
Job Description
Position: Medical Science Liaison – Oncology
Location: Kolkata & Bangalore
Qualification: MBBS/ MD Pharmacology/ PhD with extensive experience in Oncology
Experience: 0-5yr
Travel: Approximately 70% of the time
Role Purpose:
Build and strengthen medical affairs presence in oncology by engaging key stakeholders, supporting research, and sharing scientific insights on hard-to-treat cancers. Field-based role covering India.
Key Responsibilities:
Engage with KOLs, hospitals, and institutions to share fair and balanced medical information.
Support company-sponsored studies, IITs, registries, and RWE projects.
Provide medical expertise and field insights to internal teams.
Collaborate with sales, market access, and other functions to execute regional medical plans.
Ensure compliance with regulations and support patient awareness/PSP initiatives.
Profile:
MBBS/MD/PhD with 1–2 years of oncology experience.
Strong communication, stakeholder management, and scientific knowledge.
Ability to work cross-functionally with integrity and business acumen.
Proficient in English.
Note: Only candidates with relevant experience and qualification will be contacted.
Interested candidates can reach out to to expedite the process.
Medical Science Liaison- Oncology
Posted today
Job Viewed
Job Description
Domnic Lewis has been mandated to hire for a Medical Science Liaison – Oncology role with a Global Pharma MNC.
Position: Medical Science Liaison – Oncology
Location: Kolkata & Bangalore
Qualification: MBBS/ MD Pharmacology/ PhD with extensive experience in Oncology
Experience: 0-5yr
Travel: Approximately 70% of the time
Role Purpose:
Build and strengthen medical affairs presence in oncology by engaging key stakeholders, supporting research, and sharing scientific insights on hard-to-treat cancers. Field-based role covering India.
Key Responsibilities:
- Engage with KOLs, hospitals, and institutions to share fair and balanced medical information.
- Support company-sponsored studies, IITs, registries, and RWE projects.
- Provide medical expertise and field insights to internal teams.
- Collaborate with sales, market access, and other functions to execute regional medical plans.
- Ensure compliance with regulations and support patient awareness/PSP initiatives.
Profile:
- MBBS/MD/PhD with 1–2 years of oncology experience.
- Strong communication, stakeholder management, and scientific knowledge.
- Ability to work cross-functionally with integrity and business acumen.
- Proficient in English.
Note: Only candidates with relevant experience and qualification will be contacted.
Interested candidates can reach out to to expedite the process.
Medical Science Liaison- Oncology
Posted today
Job Viewed
Job Description
Domnic Lewis has been mandated to hire for a Medical Science Liaison – Oncology role with a Global Pharma MNC.
Position: Medical Science Liaison – Oncology
Location: Kolkata & Bangalore
Qualification: MBBS/ MD Pharmacology/ PhD with extensive experience in Oncology
Experience: 0-5yr
Travel: Approximately 70% of the time
Role Purpose:
Build and strengthen medical affairs presence in oncology by engaging key stakeholders, supporting research, and sharing scientific insights on hard-to-treat cancers. Field-based role covering India.
Key Responsibilities:
- Engage with KOLs, hospitals, and institutions to share fair and balanced medical information.
- Support company-sponsored studies, IITs, registries, and RWE projects.
- Provide medical expertise and field insights to internal teams.
- Collaborate with sales, market access, and other functions to execute regional medical plans.
- Ensure compliance with regulations and support patient awareness/PSP initiatives.
Profile:
- MBBS/MD/PhD with 1–2 years of oncology experience.
- Strong communication, stakeholder management, and scientific knowledge.
- Ability to work cross-functionally with integrity and business acumen.
- Proficient in English.
Note: Only candidates with relevant experience and qualification will be contacted.
Interested candidates can reach out to to expedite the process.