Clinical Research Associate

4 weeks ago


mumbai, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

Site management responsibility for clinical studies according to Fortrea’s Standard 
Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor 
requirements, including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard 
Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, 
Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and 
protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, 
query generation, and resolution against established data review guidelines on Fortrea or 
client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are 
complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate 
and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics. 
• Ensures audit readiness at site level.
• Acts in the project role of a Lead CRA as assigned.

Qualifications (Minimum Required):
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements

Experience (Minimum Required): 
• A minimum of 2 years of Clinical Monitoring experience.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.



  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Mumbai, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Navi Mumbai, India Labcorp Full time

    **Job Summary**: The Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a...

  • Clinical Dietitian

    24 hours ago


    mumbai, India DS Research Full time

    Clinical Dietitian Mumbai We are looking for a passionate and experienced Clinical Dietitian to join our team at D. S. Research Centre. As a Clinical Dietitian, you will be responsible for creating and implementing individualized nutrition plans for our patients. Responsibilities: Conducting assessments of patients' dietary needs,...

  • Clinical Dietitian

    4 weeks ago


    Mumbai, India DS Research Full time

    Clinical Dietitian Mumbai We are looking for a passionate and experienced Clinical Dietitian to join our team at D. S. Research Centre. As a Clinical Dietitian, you will be responsible for creating and implementing individualized nutrition plans for our patients. Responsibilities: Conducting assessments of patients' dietary needs, including...


  • Navi Mumbai, India Labcorp Full time

    **Essential Job Duties**: - The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study...


  • Dadar, Mumbai, Maharashtra, India Solumiks Herbaceuticals Ltd. Full time

    To monitor clinical trials in various Hospitals. - Coordinate with the Hospital staff for pre - clinical reports. - Ensure proper execution of clinical protocols in the hospitals. - Analyse statistical data generated from the clinical trials. - Prepare report and articles based on the data analysis. - Submit clinical trial documents to the ethics committee...


  • Mumbai, India Hinduja Hospital Full time

    Medical Clinical Assistant/ Associate- Gynaecology : Opportunity for Clinical Assistant/ Associate- Gynaecology Candidate should be MBBS+ MS/DNB in Gynaecology. DGO candidates might also be considered as a Registrar. Fresher's can also apply.


  • Navi Mumbai, India Labcorp Full time

    Job Summary: - Site management responsibility for clinical studies according to Labcorp Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. - Conducts site monitoring responsibilities for clinical trials according to Labcorp Standard Operating Procedures...


  • Mumbai, India Hinduja Hospital Full time

    Medical Clinical Assistant/ Associate- Urology : Opportunity for the post of Clinical Assistant/Associate-Urology for our Hospital in Mahim, Mumbai. Location: Mahim, Mumbai Qualification & Experience: MBBS + MCH (Urology).Freshers can also apply.


  • Airoli, Navi Mumbai, Maharashtra, India INDIAN BURNS RESEARCH SOCIETY Full time

    **POST: CLINICAL NUTRITIONIST** QUALIFICATION: M.Sc. / PG Diploma in Nutrition Therapy / Dietetics / Clinical Nutrition EXPERIENCE: 1-5 YRS (PREFERABLY HOSPITAL BACKGROUND ONLY) SALARY: Commensurate with Experience **Contact Address**: **INDIAN BURNS RESEARCH SOCIETY** Plot No-1,Sector-13,Airoli-w,Navi Mumbai-400708 Phone No- ...


  • Mumbai, India NMS Consultant Full time

    From 10 to 15 year(s) of experience ₹ Not Disclosed by Recruiter - Mumbai (All Areas) - Reviewing all bioequivalence study protocols and reports so as to ensure the quality and to meet regulatory requirements. - Resolving queries raised by regulatory authorities after submission of registration dossier and pre-submission queries raised by our customer -...


  • Mumbai, India Novartis Full time

    105,000 people reimagining medicine for more than 766 million people globally. To provide country clinical strategic guidance and feasibility assessment for GDD trials. Your responsibilities include, but are not limited to - To provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change the...


  • mumbai, India Hinduja Hospital Full time

    Medical Anaesthesia- Clinical Assistant/ Associate : Opportunity for Anaesthesia- Registrar/Clinical Assistant/ Associate for our Hospital in Mahim Location: Mahim Experience : Freshers can also apply Qualification: Candidate should be MD/DNB Anaesthesia. DA with minimum 1 year experience can also apply Please send your resume...