Clinical Research Associate- I

18 hours ago

Karve Nagar Pune Maharashtra, India ProRelix Research Full time

**Immediate Joiners**

**Job Summary**:
We are looking for a motivated and detail-oriented Clinical Research Associate (CRA) - I to join our Clinical Research Operations team. The CRA will be responsible for monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. This role involves close collaboration with site staff, project managers, and cross-functional teams to support the successful execution of clinical studies.

**Key Responsibilities**:

- Perform site monitoring visits (pre-study, initiation, routine, and close-out) in accordance with the monitoring plan.
- Assist in site selection and feasibility assessments.
- Ensure trial sites adhere to the study protocol, SOPs, and applicable regulatory guidelines. Verify source documents and ensure accurate data collection and reporting.
- Maintain regular communication with site staff to ensure smooth trial conduct and resolve issues proactively.
- Document and report findings in visit reports and follow-up letters.
- Support site start-up activities including document collection and regulatory submissions.
- Coordinate with clinical project teams and contribute to team meetings.
- Maintain study documentation and Trial Master File (TMF) compliance.
- Willingness to travel for site visits and monitoring activities as required by the study.
- Ensure timely identification, documentation, and escalation of protocol deviations, safety concerns, or compliance issues.
- Contribute to audit readiness by ensuring all monitoring and site activities are well documented and compliant.
- Provide input to improve study tools, processes, or monitoring practices based on site feedback and field experience.
- Support timely resolution of site queries and follow-up on pending actions from monitoring visits.
- Maintain continuous awareness of project timelines and deliverables, and take responsibility for meeting assigned milestones.

**Skills**:

- Excellent communication and interpersonal skills.
- Strong organizational and time management abilities.
- Proficient in MS Office tools (Word, Excel, Outlook, PowerPoint).
- Attention to detail and ability to work independently in a dynamic environment.
- Adaptability to work in a small team and contribute to the setup of processes and systems.

**Education**:

- Bachelor’s or Master's degree in Life Sciences, Pharmacy, Nursing, or related healthcare field.
- Certification in Clinical Research is preferred.
- Working knowledge of GCP, ICH guidelines, and basic regulatory environment.

**Experience**:

- Minimum 1 years of experience in clinical research, preferably in roles supporting trial operations or site management.
- Hands-on involvement in study coordination, site communications, or regulatory documentation.

**Job location**:
ProRelix Services LLP, Pune

**Work mode**:
Office based

**About company**:
ProRelix Research (ProRelix Services LLP) is a global clinical research organization with presence in India and USA. We are a full service clinical trial solution provider with high reputation in industry. If you are passionate and possess enthusiasm to develop and embark on a fulfilling career in clinical research industry, we encourage you to apply. Join us in out of box thinking environment where your skills and creativity will be admired for continuous personal growth.

Schedule:

- Day shift
- Monday to Friday

Work Location: In person

  • Clinical Trial Assistant- I

    18 hours ago

    Karve Nagar, Pune, Maharashtra, India ProRelix Research Full time

    **Immediate Joiner** **Job Summary**: We are seeking a highly motivated and detail-oriented Clinical Trial Assistant (CTA) - I to join our clinical operations team. The CTA will support the execution of clinical trials by providing administrative and coordination assistance. This is an entry-level position ideal for recent graduates or those with up to 6...

  • Clinical Research Associate

    6 days ago

    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**: -...

  • Clinical Research Associate

    18 hours ago

    Pune, Maharashtra, India Fusion Market Research Full time

    Responsibilities for Clinical Research Associate - Recruit and enroll study participants - Input clinical research data into electronic data systems - Coordinate patient visits and procedures related to research - Act as resource for study participants by answering questions and explaining related procedures - Ensure the study site is compliance with all...

  • Clinical Research Associate

    6 days ago

    Aurangabad, Maharashtra, India Fusion Market Research Full time

    _**Clinical Research Associate Duties and Responsibilities**_ A competent Clinical Research Associate should be able to perform various duties and responsibilities. Proper fulfillment of a Clinical Research Associate’s duties and responsibilities brings success to your company. Clinical Research Associates should assist in organizing and monitoring the...

  • Clinical Research Associate

    1 week ago

    Pune Cantonment, Pune, Maharashtra, India Pacifix Research Full time

    We are hiring enthusiastic and career-driven **Clinical Research Associates (CRA)** to join our growing team. This is an excellent opportunity for **fresher's** from **Pharmacy, Life Sciences, Biotechnology, or Medical** backgrounds to step into the Clinical Research industry. **Key Responsibilities**: Assist in clinical trial operations and...

  • Clinical Research Associate

    18 hours ago

    Kharadi, Pune, Maharashtra, India Pacifix Research Full time

    We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team. This entry-level position is ideal for recent graduates or individuals with mínimal experience in clinical research who are looking to start their careers in this dynamic field. As a CRA, you will be responsible for overseeing and monitoring clinical...

  • Clinical Research Faculty

    2 weeks ago

    Nashik, Maharashtra, India Clinomic Center For Clinical research Full time

    Experience in Clinical research. Must have well experienced in Clinical research coordinator clinical data management - 5- 8 years Pay: ₹10,000.00 - ₹15,000.00 per month Schedule: - Day shift - Morning shift Supplemental pay types: - Shift allowance **Education**: - Bachelor's (preferred) **Experience**: - Teaching: 1 year (preferred) - Making...

  • Clinical Research Associate

    18 hours ago

    Navi Mumbai, Maharashtra, India OMH HealthEdge Holdings Full time

    Vasta Bio-Informatics Private LimitedMaharashtraPosted On - 04 Oct 2024 - Required Experience - 1 - 3 Years Basic SectionNo. Of Openings 1 Grade C1B Designation CLINICAL RESEARCH ASSOCIATE Closing Date 29 Nov 2024 - OrganisationalCountry IN State MAHARASHTRA City NAVI MUMBAI Location Navi Mumbai-I - SkillsSkill CLINICAL...

  • Clinical Research Associate

    1 week ago

    Pune, Maharashtra, India Cliniweb Services Full time

    Assist in the preparation and coordination of clinical trial protocols and associated documents. - Support the monitoring of clinical trials at various stages, including site initiation, maintenance, and close-out. - Ensure that study sites are compliant with Good Clinical Practice (GCP) and regulatory requirements. - Conduct site visits to assess the...

  • Medical Writing Associate

    4 days ago

    Pune, India Jehangir Clinical Development Centre (JCDC) Full time

    Company Description Jehangir Clinical Development Centre (JCDC) is a global, clinical-stage full-service CRO providing comprehensive support for Phase I-IV clinical trials, validation studies, real world evidence (RWE) studies, and biobanking projects. With over 350 successfully executed clinical projects, JCDC has a proven track record in developing...