Clinical Research Associate

8 months ago

Gurgaon, India MSD Full time

**Clinical Research Associate**

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites.

Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:

- Data generated at site are complete, accurate and unbiased.
- Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs co-monitoring visits where appropriate.
- Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

**CORE Competency Expectations**:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.

**Behavioral Competency Expectations**:

- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Demonstrated high level of monitoring skill with independent professional judgement.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Works with high quality and compliance mind-set.
- Positive mindset, growth mindset, capable of working independently and being self-driven.
- Demonstrates and projects professional

  • Clinical Research Associate

    3 days ago

    Gurgaon, India Apothecaries Clinical Research Full time

    The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training and close-out. - Coordinating site selection, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out. - Liaising and maintaining relationships with investigators, site...

  • Clinical Research Associate

    7 months ago

    Gurgaon, India MSD Full time

    **Clinical Research Associate** - Permanent Headcount with International Pharmaceutical company - Multiple therapeutic area study to explore your clinical experience. - Best team and career development with company **WHAT YOU WILL DO** - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. -...

  • Research Associate

    16 hours ago

    Gurgaon, India medONE Pharma Solutions Full time

    We are currently looking for passionate, and committed professional to join our team as Research associates. B. Pharm, M. Pharm preferred or Bachelor's Degree in a Life Sciences discipline or health care, with Post Graduate Diploma in clinical research. The ideal profile will have 0.5- 2 years of experience. An equivalent combination of education, training...

  • Associate Clinical Research Monitor

    3 days ago

    Gurgaon, India Medtronic Full time

    **Position Description**: Responsibilities may include the following and other duties may be assigned. - Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable...

  • Clinical Research(Md Ayurveda)

    7 months ago

    Gurgaon, India Nirvasa Healthcare Pvt. Ltd. Full time

    **Eligibility - Must have MD in Ayurveda**: - **Work from office**: - **Location - Gurgaon**: - **5 working days**: - **Experience Level**: 2-3 years of Ayurveda Practice/ Clinical Research (Ayurveda) **Company**: Nirvasa Pvt Ltd As a Clinical Research Analyst specializing in Ayurveda at Nirvasa Pvt Ltd, you will be an essential part of our research...

  • Medical Writer I

    7 months ago

    Gurgaon, India Syneos Health Clinical Full time

    **Description** **Medical Writer I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

  • Medical Writer I

    7 months ago

    Gurgaon, India Syneos Health Clinical Full time

    **Description** **Medical Writer I (R**edaction/Clinical Trial Transparency)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...

  • Clinical Development Research Specialist

    2 weeks ago

    Gurgaon, Haryana, India Everest Group Full time

    About Everest GroupEverest Group is a leading research firm that empowers business leaders to navigate today's market challenges with confidence. Our team of experts delivers precise and action-oriented guidance, helping organizations maximize operational and financial performance while driving transformative experiences.The Clinical Development Technologies...

  • Research Associate

    7 days ago

    Gurgaon, India Clarivate Full time

    We are looking for Research Associate to join our LifeScience and Healthcare Products business group in Gurgaon. This is an amazing opportunity to be a member of a talented and vibrant Biopharma Insights team. The team consists of about 100 people and is reporting to the Director/Senior Director. We have a great skill set in market research and assessment,...

  • Regulatory Associate

    7 days ago

    Gurgaon, India Syneos Health Clinical Full time

    **Description** **Regulatory Associate** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team,...

  • Research Associate

    3 days ago

    Gurgaon, India cocentrus Full time

    Hiring for the **Primary Research Associate** profile for **Gurgaon** location.please find the job responsibility as below: - **Job Title** : Primary Research Associate **Experience** : Fresher **Salary Budget** : Up To 4.00 LPA **Location** : Gurgaon **Working Days ** : Monday To Friday **Shift Timings** : Rotational Shift Depends on projects **Job...

  • Healthcare Research Associate

    6 months ago

    Gurgaon, India Neo Research Consulting Full time

    **Responsibilities**: **Research Design and Execution**:Develop and execute research plans, including literature reviews, study design, and data collection methodologies. Collaborate with cross-functional teams to ensure the successful implementation of research projects. **Data Collection and Analysis**:Collect, organize, and analyze healthcare data using...

  • Research Associate

    16 hours 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...

  • Senior Manager

    2 months ago

    Gurgaon, India Naari Pharma Pvt Ltd. Full time

    Who You Are:You are a detail-oriented and proactive with experience in overseeing BA/BE and clinical studies. You excel in coordinating between internal teams, external vendors, and regulatory bodies to ensure timely execution of clinical and bioanalytical phases. With strong negotiation, communication, and project management skills, you thrive in managing...

  • Senior manager

    2 months ago

    Gurgaon, India Naari Pharma Pvt Ltd. Full time

    Who You Are:You are a detail-oriented and proactive with experience in overseeing BA/BE and clinical studies. You excel in coordinating between internal teams, external vendors, and regulatory bodies to ensure timely execution of clinical and bioanalytical phases. With strong negotiation, communication, and project management skills, you thrive in managing...

  • Director of Clinical Operations

    1 month ago

    Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    Overview:Navigating the dynamic landscape of clinical research, Naari Pharma Pvt Ltd. seeks a seasoned Director of Clinical Operations to spearhead BA/BE and clinical studies. This pivotal role demands expertise in coordinating cross-functional teams, external vendors, and regulatory bodies to drive timely project execution.

  • Assistant professor/ associate professor/ professor

    2 weeks ago

    Gurgaon, India GD Goenka University Full time

    Assistant Professor/ Associate Professor/ Professor GD Goenka University is inviting applications for faculty positions, including Assistant Professor, Associate Professor, and Full Professor, to join and enrich its academic team . We welcome applications in the following academic areas: We welcome applications in the following academic areas: ...

  • Research Associate

    16 hours 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...

  • Clinical Development Expert

    4 weeks ago

    Gurgaon, Haryana, India Everest Group Full time

    Everest GroupAbout UsWe are a research firm that helps business leaders make informed decisions with confidence. Our deep expertise and tenacious research focus on software, technology, business processes, and engineering through the lenses of talent, sustainability, and sourcing.The Clinical Development Technologies team focuses on current and anticipated...

  • Research Associate

    16 hours 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...