JOB SUMMARY

The position is responsible for providing clerical, technical and administrative support to one or more business units or clients within Clinical Operations. Provides overall study support to functional leads to ensure the successful completion of project deliverables. Mentors and/or trains less experienced staff.

JOB RESPONSIBILITIES

· Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions

· Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines

· Creates and assists with maintenance of project files, handles project correspondence

· Participates in file audits

· Prepares and maintains site manuals, reference tools and other documents

· Maintains, updates, and inputs clinical tracking information into databases

· Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client

· Manages shared mailbox, processes site requests and routes correspondence appropriately

· Coordinates the ordering, packaging, shipping and tracking of site supplies and materials

· Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items

· Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues

· Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.

· May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)

• Associates degree preferred or equivalent
• Experience in clinical research/pharma/biotech or related field considered in lieu of degree
• Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
• Ability to successfully prioritize and work on multiple tasks
• Strong attention to detail, accuracy and organizational skills
• Excellent communication, presentation, and interpersonal skills
• Ability to embrace new technologies
• Minimal travel up to 10% may be required

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.