Clinical Research Associate

3 weeks ago


Thane District Maharashtra, India Ibhaan Pharmaceuticals Full time

Act as the company’s direct point of contact with the assigned sites, accountable for quality and delivery during all the phases of the study (Start up, Initiation through closeout)

Build relationships with investigators and site staff

Preparation, negotiation and facilitation of execution of Confidentiality Agreements, Clinical site agreements and any amendments

Generate visit or contract reports, using judgement to identify site issues and problem solving to direct resolution

Customize, review and negotiate as needed, site specific ICFs, translations & customise and negotiate any amendments

Submit all pertinent documentation to the TMF as per project plan

Forecast, develop, manage and revise plans and strategies for EC submission, regulatory submission and approval, site activation, patient recruitment and retention

Actively participate in Investigator and other external or internal meetings, Audits and regulatory inspections, conduct on site study specific training if required

Work in a self-driven capacity with limited need for oversight, Show commitment and perform consistent high quality work

Proactively keep manager informed about work progress and any issues

Address and resolve any issues at site including the need for additional training potential deficiencies in documentation and communication

Perform on site visits [site feasibility, site initiations through closeouts] and generate visit reports

Assess and manage IP supply including supply accountability, destruction/return status

Review and follow up site payment status

Follow up on CRF data entry/query status and SAEs

Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, encourage the support of team members were required

Update all appropriate clinical trial management systems on an ongoing basis, perform regular reviews of site level data, ensure timely and high quality data entry & compliance from sites, manage and submit all relevant documents to the trial master file, ensuring first time quality and distribute study documents to site including configuration of Investigator site files if applicable and ongoing maintenance for completeness and quality

Ensure that assigned sites are audit and inspection ready

Monitor and maintain compliance with ICH GCP and applicable international and local regulations

Maintain a positive result oriented work environment, building partnerships and collaborative relationship, communicating with team in an open balanced objective manner thus modelling high performance culture values

Maintain a working knowledge of and ensure compliance with applicable ICH GCP guidelines, international and local regulations, companies sops, sponsor’s training requirements, study specific procedures plans and training

Ensure basic understanding of project scope, milestones, budgets and study for high quality timely and efficient delivery

Complete additional tasks in a timely manner

**Job Types**: Full-time, Permanent

Schedule:

- Day shift

Ability to commute/relocate:

- Thane, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)



  • Pune, Maharashtra, India Ascentrik Research Pvt Ltd Full time

    **Job Type - Fresher or Internship level** Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. **Responsibilities**: **1. Assist in Protocol Development**: -...


  • Thane, India Biosphere Clinical Research Pvt. Ltd. Full time

    To coordinate with Principal Investigator, Research department and Ethics committee for a new Clinical Trial Start up (CDA, FQ, PSP, IU & other). To coordinate with Principal Investigator to help ensure that clinical research and related activities are performed. - To coordinate and facilitate monitoring and auditing visits. - EC Submission. - Completion of...


  • Thane, India Fusion Research Full time

    We are seeking a dedicated and enthusiastic individual to join our team as a Clinical Research Coordinator. This is an excellent opportunity for a recent graduate or entry-level professional looking to gain valuable experience in the field of clinical research. As a Clinical Research Coordinator, you will play a key role in assisting with the planning,...


  • 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...


  • Mumbai, Maharashtra, India Novartis Full time

    393172BR **Clinical Research Medical Advisor**: India **About the role** Novartis is a pioneer in drug development with a robust pipeline across therapy areas. CRMAs work closely with Investigators and ensure scientific engagement with the Investigator community to drive our programs and trials across the globe. Your responsibilities include, but are not...


  • Thane, India Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Thane, India Armsoftech private limited Full time

    URGENT REQUIREMENT FOR ( HEAPS ) CLINICAL ASSOCIATE PROCESS. Salary : Up to ₹ 18,000 per month. **Salary**: Up to ₹18,000.00 per month Schedule: - Day shift Work Location: In person


  • Pune, Maharashtra, India Research NXT Full time

    Being Analytical, Excellent in Research, Good at Searching, Reading between the lines, compiling data from various sources and repeating it umpteen times daily.**Research Associate - Data Business - B0223 (FRESHERS ONLY)** **Are you the one?** Sherlock Holmes is a no-brainer! We all have lived the fantasies of becoming one. Being Analytical, Excellent in...

  • Clinical Nutritionist

    4 weeks ago


    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...

  • Qc Chemist

    1 month ago


    Navi Mumbai, Maharashtra, India Promas Research Laboratories Pvt. Ltd. Full time

    As a senior research associate, your job duties include performing clinical research, complex testing of samples, data collection, and analysis of results. In this job, you direct researchers in your lab and collaborate with other scientific professionals to design experiments or compare results. 1. Performing Analytical Method Development & Method...

  • Research Associate

    1 month ago


    Gurgaon District, Haryana, India Unimrkt Research Full time

    **Location**: Gurugram **Shift Timings**: Rotational Shifts - Collect data on company demographics and preferences/needs. - Devise and evaluate methods and procedures for collecting data, such as surveys, opinion polls, or questionnaires, or arrange to obtain existing data. - Doing secondary research following the project assigned. - Conducting telephonic...


  • Pune, Maharashtra, India Axiom Market Research & Consulting Full time

    As a Market Research Associate, you will play a pivotal role in driving strategic business decisions through comprehensive market analysis and insightful data interpretation. This role demands a passion for research, an analytical mindset, and a keen understanding of market trends. Key Responsibilities: - Conduct in-depth research on companies, industries,...

  • Research Associate

    1 month ago


    Gurgaon District, Haryana, India Unimrkt Research Full time

    **Location**: Gurugram **Shift Timings**: Rotational Shifts - Conducting telephonic interviews with respondents such as C-level executives, Directors and Manager level etc; compiling and recording the results and data obtained from the interviews. - Collecting data on customer demographics and preferences/ needs. - Helping in secondary research as and when...

  • Research Associate

    1 month ago


    Gurgaon District, Haryana, India Unimrkt Research Full time

    **Location**: Gurugram **Shift Timings**: Rotational Shifts - Collect data on company demographics and preferences/needs. - Devise and evaluate methods and procedures for collecting data, such as surveys, opinion polls, or questionnaires, or arrange to obtain existing data. - Doing secondary research following the project assigned. - Conducting telephonic...

  • Clinical Psychologist

    1 month ago


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

    **POST: CLINICAL PSYCHOLOGIST** QUALIFICATION: Master's in **PSYCHOLOGY** 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- 022-27796660 /61/62/63 **NEARBY CANDIDATES PREFERRED.** **Job...


  • Thane, India Vertex Business Solutions Full time

    As a Clinical Trials Coordinator, you will play a crucial role in the planning, execution, and monitoring of clinical trials conducted within our organization. This position offers an exciting opportunity for individuals with a strong interest in clinical research to gain hands-on experience in a dynamic and collaborative...

  • Research Associate

    1 day ago


    Pimple Soudagar, Pune, Maharashtra, India Infinium Global Research LLP Full time

    **Job description**: We are looking for an organized, flexible Research Associate to write analytical reports on different verticals such as Chemicals & Materials / Healthcare / Food & Beverages/ Consumer Goods/ ICT etc. on key market trends and on key issues impacting the industry. **Role & responsibilities**: - Managing the delivery of insightful and...


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

    Writing clinical trial protocol - Preparing SOP for selection of patient - Site initializing - Monitoring progress of trial - Ethics Committee submission - Data Analysis - Report writing - Publication in Peer reviewed journals **Job Types**: Full-time, Contract Contract length: 60 months **Salary**: From ₹40,000.00 per month **Benefits**: - Flexible...

  • Clinical Dietitian

    1 week ago


    Thane, India Trinity Empowerment Full time

    **Job Summary**: The Clinical Dietician will be responsible for assessing the nutritional needs of patients, developing and implementing nutrition programs, and providing education and support to promote healthy eating habits. This role requires a compassionate individual who can work collaboratively with healthcare professionals to enhance patient...


  • Pashan, Pune, Maharashtra, India Acesso Innovation Lab Full time

    **Responsibilities** - Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations - Serve as primary Sponsor contact for operational project-specific issues and study deliverables - Maintain in depth knowledge of protocol, therapeutic...