Clinical Research Associate I

4 days ago

Beijing, Beijing, China Parexel Full time

Parexel is seeking a highly skilled Clinical Research Associate I to join our team in this exciting role. As a key member of our site management team, you will be responsible for ensuring the timely and accurate completion of project goals and update of applicable trial management systems.

Job Summary

We are looking for a motivated and detail-oriented individual with excellent communication and problem-solving skills to work as a Clinical Research Associate I. In this role, you will be responsible for building relationships with investigators and site staff, facilitating and supporting sites with access to relevant study systems, and ensuring compliance with all project specific training requirements.

Responsibilities
  • Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • BUILD RELATIONSHIPS WITH INVESTIGATORS AND SITE STAFF.
  • CONDUCT, DRIVE AND MANAGE COUNTRY SPECIFIC FEASIBILITY AND/OR SITE PRE-QUALIFICATION AND QUALIFICATION ACTIVITIES, WHICH MAY INCLUDE:
    • -PREPARATION, NEGOTIATION, AND FACILITATION OF EXECUTION OF CONFIDENTIALITY AGREEMENTS (CDA), CLINICAL SITE AGREEMENTS (CSAS) AND ANY AMENDMENTS.
    • -CONDUCT REMOTE QUALIFICATION VISITS (QVS).
  • GENERATE VISIT/CONTACT REPORTS, USING JUDGMENT TO IDENTIFY SITE ISSUES AND PROBLEM SOLVING TO DIRECT RESOLUTION.
  • DEVELOP STRATEGY TO CONFIGURE, DISTRIBUTE, AND COLLECT, AND REVIEW AND APPROVE, HIGH QUALITY COUNTRY SPECIFIC AND/OR SITE SPECIFIC DOCUMENTS OR ESSENTIAL REGULATORY DOCUMENTS (SRPS) AND ANY UPDATED OR AMENDED REGULATORY DOCUMENTATION.
  • CUSTOMIZE, REVIEW, AND NEGOTIATE AS NEEDED, COUNTRY/SITE SPECIFIC INFORMED CONSENT FORMS (ICFS), TRANSLATIONS (WITHIN PARAMETERS OF COUNTRY/REGULATORY/CLIENT REQUIREMENTS), AND CUSTOMIZE AND NEGOTIATE ANY AMENDMENTS.
  • PREPARE AND SUBMIT IRB/IEC AND MOH/RA (IF APPLICABLE) APPLICATION(S), RESOLVING CONFLICTS, DETERMINING APPROPRIATE FOLLOW UP UNTIL RECEIPT OF FINAL APPROVAL.
  • SUBMIT ALL PERTINENT DOCUMENTATION TO THE TRIAL MASTER FILE AS PER PROJECT PLANS/SPONSOR/COMPANY POLICY.
  • FORECAST, DEVELOP, MANAGE, AND REVISE PLANS AND STRATEGIES FOR:
    • -IRB/IEC AND MOH / RA SUBMISSION/APPROVAL,
    • -SITE ACTIVATION,
    • -PATIENT RECRUITMENT & RETENTION.
  • UPDATE AND MAINTAIN APPROPRIATE CLINICAL TRIAL MANAGEMENT SYSTEMS (CTMS) IN A TIMELY MANNER.
  • PROMPTLY IDENTIFY, USE JUDGMENT AND KNOWLEDGE TO ADDRESS AND RESOLVE OR ESCALATE, ANY SITE QUESTION AND/OR ISSUE, INCLUDING BUT NOT LIMITED TO: POTENTIAL ISSUES OR RISKS WITH SITE ACTIVATION TIMELINES, ISSUES WITH PATIENT RECRUITMENT STRATEGY, DEFICIENCIES IN TRAINING, DATA QUALITY OR INTEGRITY, STUDY NON-COMPLIANCE, ETC.
  • FACILITATE AND SUPPORT ALLOCATED SITES WITH ACCESS TO RELEVANT STUDY SYSTEMS AND ENSURE THEY ARE COMPLIANT WITH ALL PROJECT SPECIFIC TRAINING REQUIREMENTS PRIOR TO STUDY START.
  • ACTIVELY PARTICIPATE IN INVESTIGATOR AND OTHER EXTERNAL OR INTERNAL MEETINGS, AUDITS & REGULATORY INSPECTIONS
  • WORK IN A SELF-DRIVEN CAPACITY, WITH LIMITED NEED FOR OVERSIGHT.
  • PROACTIVELY KEEP MANAGER INFORMED ABOUT WORK PROGRESS AND ANY ISSUES.
Qualifications
  • PREVIOUS RELEVANT WORK EXPERIENCE PREFERRED.
  • EDUCATED TO DEGREE LEVEL (BIOLOGICAL SCIENCE, PHARMACY, OR OTHER HEALTH-RELATED DISCIPLINE PREFERRED) OR EQUIVALENT NURSING QUALIFICATION OR OTHER EQUIVALENT EXPERIENCE.

The salary for this position is approximately $65,000 per year, based on national averages in the United States. However, please note that salaries can vary widely depending on location, experience, and other factors. We strive to offer competitive compensation packages to attract and retain top talent.

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