Clinical Research Associate

4 weeks ago

Mumbai, India REGROW BIOSCIENCES Full time

Overview:
As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.
Responsibilities:
1 . Trial Preparation : Assist in the development of study protocols, informed consent forms, and other essential trial documents. Coordinate with investigative sites to ensure proper training and understanding of trial procedures. Participate in the selection and qualification of clinical sites and investigators.
2. Trial Execution : Conduct site initiation, monitoring, and close-out visits to ensure adherence to protocol, regulatory requirements, and GCP guidelines. Perform source data verification and data review to ensure accuracy and completeness of clinical trial data. Act as a liaison between clinical sites, sponsors, and regulatory authorities, addressing any queries or issues that arise during the trial. Monitor subject safety and report adverse events in accordance with regulatory requirements.
3. Documentation and Compliance : Maintain accurate and up-to-date trial documentation, including regulatory files, trial master files, and study documentation. Ensure compliance with India FDA, drugs & Cosmetics Act and other relevant regulatory guidelines and standards.
4. Communication and Collaboration : Communicate effectively with internal stakeholders, including project teams, clinical operations, and regulatory affairs. Foster collaborative relationships with external stakeholders, including clinical investigators, study coordinators, and contract research organizations (CROs).
5. Regulatory: Preparing scientific documents, dossiers, Assist in the preparation of regulatory submissions and responses to regulatory inquiries. Government regulatory submissions as per Clinical Trial guidelines
5. Quality Assurance: Participate in internal and external quality assurance audits and inspections, Identify and mitigate risks to trial integrity and data quality.
6 . Site Monitoring : Conduct regular site visits to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
7 . Qualifications: Bachelor‘s degree in a scientific or healthcare-related field
- Certification as a Clinical Research Associate (CCRA) or equivalent.
- Experience with cell therapy clinical trials, including knowledge of cell processing techniques and regulatory requirements specific to cell-based therapies.
- Familiarity with advanced therapy medicinal products (ATMPs) and cell therapies, autoimmune, oncology and Clinical Trial.
8. Skills:
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in MS Office and clinical trial management systems.

  • Clinical Research Faculty

    24 hours ago

    Borivali, Mumbai, Maharashtra, India Clinomic Center For Clinical research Full time

    all Clinical Research Topic: - DRUG DEVELOPMENT: FROM MOLECULE TO PRESCRIPTION: PART 1 DRUG DEVELOPMENT: FROM MOLECULE TO PRESCRIPTION: PART 2 THE EVALUTION OF THE CLINICAL TRIAL PROCESS-A BRIEF HISTORY LESSON HISTORICAL BACKGROUND OF GCPINSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)STAKEHOLDERS ENGAGEMENT TO ENSURE A SUCCESSFUL TRIAL...

  • Clinical Research Associate

    30 minutes ago

    Mumbai, Maharashtra, India REGROW BIOSCIENCES Full time

    About the company and the position:Hey there! Are you a Clinical Research Associate (CRA) looking for an exciting opportunity to be a key player in clinical trials? Well, look no further! Join our team and be a crucial part of the development and execution of cutting-edge clinical research. Here's what you'll be doing:Responsibilities: Assist in developing...

  • Clinical Research Associate

    2 weeks ago

    mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1 . Trial...

  • Clinical Research Associate

    2 months ago

    mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1 . Trial...

  • Clinical Research Associate

    2 months ago

    Mumbai, India Novo Nordisk Full time

    **Department: Clinical Development Centre** Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find...

  • Clinical Research Associate

    2 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    2 weeks ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    2 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    2 weeks ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview: As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process. Responsibilities: 1 . Trial...

  • Clinical Research Associate

    2 weeks ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    2 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview: As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process. Responsibilities: 1 . Trial...

  • Clinical Research Associate

    3 hours ago

    Mumbai, Maharashtra, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial processResponsibilities:1 Trial...

  • Clinical Research Associate

    9 hours ago

    Mumbai, Maharashtra, India Novo Nordisk Full time

    Department: Clinical Development CentreDo you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find challenges...

  • Clinical Research Associate

    6 days ago

    Mumbai, India Statistical Pharma Full time

    Specific duties can vary depending on the company, but clinical research associates will generally be required to: - Develop trial procedures, methodology and instructions for clinical trials staff, as well as design data collection tools (case report forms) - Manage study supplies, drug supplies and drug accountability (and prepare study drugs for...

  • Clinical Research Associate

    2 weeks ago

    Mumbai, India BIORASI LLC Full time

    **We are Growing**! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of. Biorasi is looking for top...

  • Clinical Research Coordinator

    2 months ago

    Mumbai, India Learning Labb Research Institute Full time

    We are seeking a motivated and detail-oriented Clinical Research Coordinator to join our dynamic team. As a Clinical Research Coordinator, you will play a crucial role in the planning, implementation, and coordination of clinical research studies. You will work closely with principal investigators, study participants, and other healthcare professionals to...

  • Clinical Research Coordinator

    2 months ago

    Mumbai, India Learning Labb Research Institute Full time

    We are seeking a motivated and detail-oriented Clinical Research Coordinator to join our dynamic team. As a Clinical Research Coordinator, you will play a crucial role in the planning, implementation, and coordination of clinical research studies. You will work closely with principal investigators, study participants, and other healthcare professionals to...

  • Clinical Research Associate

    7 days ago

    Navi Mumbai, Maharashtra, India Medpace, Inc. Full time

    Job Summary: Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include: - Nurses - Dieticians - Pharmacy Technicians - Pharmaceutical/Device Sales Representatives - Biotech Engineers - Health and Wellness Coordinators - Research...

  • Experienced Clinical Research Associate

    7 days ago

    Navi Mumbai, Maharashtra, India Medpace, Inc. Full time

    Job Summary: Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include: - Nurses - Dieticians - Pharmacy Technicians - Pharmaceutical/Device Sales Representatives - Biotech Engineers - Health and Wellness Coordinators - Research...

  • Clinical Research Associate

    6 hours ago

    Mumbai, Maharashtra, India Novartis Full time

    Summary:Monitors patient data & study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related...