Position Overview:
The Clinical Trial Specialist (CTS) at PERI plays a key role in accomplishing tasks and projects that are instrumental to successful execution of assigned programs. The CTS engages in clinical trial management on a day-to-day level, while working closely with the project Clinical Trial Manager (CTM) for timely delivery of recurrent tasks consistently with a high degree of accuracy. The CTS compiles and maintains project-specific status reports, interacts with the sponsor, study sites and internal associates, and provides oversight and quality control of our internal regulatory filing system.
Required Skills and Experience:
•Bachelor's degree in scientific or health related field
•Minimum of two years of experience in a clinical operations role at a CRO or Sponsor
•Working knowledge of clinical drug development process, along with ICH-GCP guidelines and FDA regulations
•Proven problem-solving abilities and propensity for independent working style
•Effective time-management and prioritization skills
•Must possess soft skills and team player mentality
•Excellent computer, organizational, and time management skills
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Assists with site management activities, including communicating with sites to collect regulatory documents, support IRB submissions, discuss screening/enrollment activities and other project specific requirements.
•Maintains study-level timelines and data entered into PERI systems.
•Creates and assists with maintenance of Trial Master File and project files, including participation in TMF audits.
•Prepares and maintains site manuals, reference tools, and other project specific documents.
•Requests and manages project specific system accesses for internal study team and sites.
•Aids with coordination of team meetings, including preparing meeting minutes and action items.
•Contributes to vendor management in tandem with Clinical Trial Manager, including maintaining sample tracking logs.
•Updates study dashboards, status trackers, and other applicable study documents to provide regular updates on trial status.
•Maintains oversight for completion of study specific training across functional areas
•Supports clinical team with ad hoc requests as needed, from study start up through study closure.
•Upholds a professional interpersonal relationship with study team, sites and sponsors.
•Demonstrates proficient knowledge of FDA regulations and ICH-GCP guidelines, as applies to both premarket and post-market studies.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. While performing the duties of this job, the employee is regularly required to sit, talk, hear, and use hands to write, type or operate office equipment. The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and smell. The employee is required to perform repetitive motions, including reaching above the head, and typing. The employee must occasionally lift up to 50 pounds and/or carry objects weighing up to 25 pounds. Specific vision abilities required by this job include peripheral vision, depth perception, and ability to adjust focus.