Clinical research associate (Zydus)

Roles and Responsibilities

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 close-out 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 US-based 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

· 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. Follow-up 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 well-organized 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 non-traditional workday hours.

  · The ideal candidate must be able to work independently.

  · Personal interactions are critical to the role. Must have good inter-relationship skills.

  · The individual in the position will be expected to coordinate activities during the local time zones for the investigational sites and US-based CRAs.

  EDUCATION & EXPERIENCE:

  · Minimum of Bachelor’s Degree, preferably in life sciences.