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    Clinical Research Associate-I

    Prorelix Research
    1-2 years
    Not Disclosed
    Boston Remote, USA
    10 Feb. 11, 2025
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Research Associate-I
    Location: Pune, India
    Experience Required: 01-02 years
    Job Type: Full-Time

    Job Summary:

    ProRelix Research is seeking a motivated and dynamic Clinical Research Associate-I (CRA-I) to join our growing team. The ideal candidate will be responsible for supporting clinical trials by ensuring proper management and execution of clinical research activities according to Good Clinical Practice (GCP), regulatory requirements, and company protocols. This role will involve working closely with the clinical team, investigators, and study coordinators to ensure the successful implementation of clinical studies.

    Key Responsibilities:

    1. Clinical Trial Management:

      • Assist in the planning, execution, and monitoring of clinical trials, ensuring adherence to study protocols, regulatory guidelines, and internal standard operating procedures (SOPs).
      • Support the preparation of regulatory submissions and documentation required for clinical trials.
      • Ensure proper handling, tracking, and documentation of study materials, including investigational products (IP).

    2. Site Management:

      • Perform site initiation, monitoring, and close-out activities to ensure compliance with study protocols and regulatory requirements.
      • Coordinate with investigators and clinical sites to ensure the timely recruitment of subjects.
      • Conduct routine site visits to monitor the progress of the clinical trial and resolve any issues that may arise.
      • Ensure the proper training and support for site staff, ensuring that they adhere to GCP and study protocols.

    3. Data Collection and Reporting:

      • Ensure accurate and timely data collection and documentation from clinical sites.
      • Review case report forms (CRFs) and ensure that data entered is complete, accurate, and consistent with the source data.
      • Provide regular updates on clinical trial progress, including site performance, recruitment rates, and any challenges faced during the trial.

    4. Compliance and Quality Assurance:

      • Monitor clinical trial activities to ensure that all processes comply with regulatory requirements, ethical guidelines, and company policies.
      • Ensure that adverse events (AEs) and serious adverse events (SAEs) are promptly reported and followed up on.
      • Assist in audits and inspections by regulatory authorities and sponsor representatives.

    5. Collaboration and Communication:

      • Collaborate with internal teams (e.g., data management, regulatory, safety, and medical teams) to ensure smooth execution of clinical trials.
      • Communicate effectively with investigators, clinical trial coordinators, and site staff to resolve any trial-related issues.

    6. Documentation and Reporting:

      • Maintain study-related documents, including regulatory files, ethics committee submissions, and patient records.
      • Ensure the proper documentation of study progress, monitoring activities, and any deviations or changes in the study plan.

    Key Skills & Qualifications:

    • Educational Qualification:

      • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (B.Sc, M.Sc, B.Pharm, M.Pharm).

    • Experience:

      • 01-02 years of experience in clinical research or related fields, preferably within a CRO or pharmaceutical industry.
      • Previous experience with clinical trial monitoring and site management is an advantage.

    • Technical Skills:

      • Knowledge of Good Clinical Practice (GCP) and regulatory requirements for clinical trials.
      • Familiarity with clinical trial management software (CTMS) and databases.
      • Strong organizational and time management skills with the ability to prioritize tasks effectively.

    • Soft Skills:

      • Excellent verbal and written communication skills.
      • Attention to detail and ability to manage multiple tasks simultaneously.
      • Strong problem-solving and critical thinking abilities.
      • Ability to work both independently and as part of a team.

    • Preferred Skills:

      • Experience in clinical research data management and monitoring.
      • Knowledge of regulatory submissions and compliance documentation.

    Why ProRelix Research?

    • Career Growth:
      At ProRelix Research, you will have the opportunity to develop your skills and advance in your clinical research career with exposure to a wide variety of clinical studies.

    • Collaborative Work Environment:
      Work alongside an experienced team of professionals committed to making a difference in clinical research and patient outcomes.

    • Competitive Compensation:
      We offer competitive compensation and benefits, along with opportunities for professional development and career growth.

    Interested candidates are encouraged to send their CVs to career@prorelixresearch.com to explore career opportunities with ProRelix Research.

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