Clinical Research Associate Role

1 week ago


Ahmedabad, Gujarat, India Zydus Group Full time
Department

  • ZTI
  • Job posted on


Apr 11, 202
  • Employment type
  • P-P8Probationer-HO Executive

RESPONSIBILITIES:

  • Manage assigned investigational sites in a remote capacity.
  • Perform remote monitoring of assigned investigational sites, including: site qualification visits, site initiation visits, routine monitoring visits, and closeout visits.
  • Support Project Management in the conduct of site feasibility assessments (may include participating in or managing the site selection process, analyzing patient recruitment and retention rates).
  • Assist in the planning of site initiation visits and site training activities.
  • May function as the primary point of contact with the site.
  • Coordinate activities with USbased regional CRAs.
  • Monitor site recruitment and enrollment activities. When applicable, coordinate recruitment plans with applicable sites.
  • Perform review and reconciliation of regulatory documents remotely at the investigational site against the trial master file.
  • Verify biological sample collection, storage, and shipping procedures at the site.
  • Review and reconcile laboratory data to ensure it is properly captured in the case report form, and if necessary, is reconciled with the CRF.
  • Review investigational product status in IRT systems.
  • Ensure study supplies are maintained in an ongoing manner.
  • Ensure timely completion of case report form data and query reconciliation. Followup with sites directly to ensure compliance with study metrics for data completion and query resolution.

QUALIFICATIONS - SKILLS & REQUIREMENTS:

  • Strong grasp of International Conference on Harmonisation Good Clinical Practice guidelines.
  • A keen understanding of the regulatory requirements in the United States, as they pertain to the conduct and oversight of clinical trials.
  • Proficient in various electronic data capture and clinical trial management systems. Proficient in Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat.
  • Must be wellorganized and possess attention to detail.
  • Must have excellent verbal and written skills.
  • Fluent in English (additional language skills will be noted).
  • Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances when meetings are scheduled during nontraditional workday hours.
  • Personal interactions are critical to the role. Must have good interrelationship skills.
  • The individual in the position will be expected to coordinate activities during the local time zones for the investigational sites and USbased CRAs.

EDUCATION & EXPERIENCE:

  • Minimum of Bachelor's Degree, preferably in life sciences.
  • At least 3 years as a fulltime regional monitor working for a sponsor or Contract Research Organization (CRO).
  • Extensive experience performing source data verification in an electronic data capture environment.
  • Experience with paper and electronic document management systems (eTMF, CTMS, etc.).
  • Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations.
  • Experience managing serious adverse events in collaboration with safety surveillance.
  • Extensive experience collaborating/interacting with counterparts at sponsors and other CROs/vendors (laboratories, drug depots, etc.).
  • Experience providing training to new employees and existing employees for new and updated procedures.

WORK ENVIRONMENT:

This position is
remote and will be based in India.

While the position will be home-based, there may be some travel required to the home office based in Ahmedabad, from time to time.

The role will report into the Pennington, NJ office. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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