Clinical Trial Associate at Pinnacle Clinical Research- A Summit Solution

Job Title: Clinical Trial Associate

Reports To: PM Manager

Department: Operations

FLSA Status: Exempt

Business Unit: IRO

Summary: The Clinical Trial Associate assists the Summit Project Management team with operational planning, scheduling, and managing of deliverables associated with sponsor protocols and clinical trial sites. The Clinical Trial Associate will work with sponsor requirements utilizing the project specific SOW, protocols, and other data to identify requirements to assist with planning, budgeting, estimating enrollment requirements and forecasting.

The Clinical Trial Associate will work in close collaboration with the Project Management team of SUMMIT

Duties and Responsibilities

• Assist in the preparation, handling, distribution, filing, and tracking of clinical documentation and reports
• Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes
• Assist in updates for all clinical trials tracking tools
• Assist in maintaining internal trackers for clinical study activities and study documents
• Serve as administrative point of contact for internal teams and for external sponsors and CROs
• Coordinates distribution and shipment of study-related materials
• Provides general support to the Project Management team on other clinical trial related duties and tasks, as required
• Maintains central registry of contact information for clinical sites, CROs, vendors and sponsors
• Assists with the organization of internal team meetings, and other trial-specific meetings
• Assist with and track Start-up items such as regulatory completion and IRB submission if needed, as well as to provide escalation support for Sponsor, CRO, and sites.
• Track completion of study set-up items such as Lab kits, IRT, EDC, trainings, SIVs, and vendor qualifications.
• Other duties as assigned

Qualifications:

• 2 years of experience in Clinical Research

Knowledge, Skills, and Other Abilities:

• Ability to synthesize data, with strong attention to detail and accuracy
• Strong knowledge and understanding of ICH Guidelines, FDA regulations, and GCPs
• Excellent written and verbal communication skills. Capable of developing precise, accurate written and verbal communications
• Ability to effectively work across multiple projects, and with multiple organizations in a professional manner
• Excellent reporting skills

• Excellent written and oral communication skills

• Organizational skills

• Ability to pay attention to detail

• People skills including possessing a positive, friendly, and professional demeanor

• Ability to be flexible with changing priorities

• Ability to communicate in a diplomatic and professional manner

• Strong interpersonal skills

• Strong mathematical knowledge

• Excellent computer skills

• Knowledge of Microsoft Office, internet browsers, and web-based enterprise solutions software.

Work Environment and Physical Demands: The work environment and 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Work may be performed in an office environment.
• Occasional domestic and/or international travel may be required (20%).