Sr. Clinical Research Associate
The Judge Group Inc.

Job Info

---

Location: REMOTE
Description: Our client is currently seeking a Sr. Clinical Research Associate

This job will have the following responsibilities:

• Title: Sr. Clinical Research Associate
• Job Type: Permanent
• Location: Princeton,NJ-note: fully remote now-Plan in 2022 is to roll people eventually back in-house, 2-3 days per week).
• Summary:
• The Sr. Clinical Research Associate will be responsible for site management and reporting of trials in accordance with company plans/objectives, ICH/GCP, local requirements and company standard operating procedures. Additional responsibilities will include in-house data review and occasionally leading the planning and development of study set-up.
• Primary Responsibilities
• Acts as primary point of contact for investigative sites and cross functional teams and escalates to the study lead as necessary.
• May lead the development of study-related documents such as study manuals, monitoring plans, informed consents, recruitment materials and other study related tools.
• Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and User Acceptance Testing (UAT).
• Performs in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.
• Responsible for the development and distribution of study newsletters and tracking/reporting of recruitment updates.
• May participate in monitoring/co-monitoring and/or training visits, TMF and on-site audits as requested.
• Participates in the training of investigative sites and third-party vendors.
• Assists with providing oversight of CROs and vendors, including managing cross-functional teams.
• May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs including directing/guiding day to day activities and review/approval of monitoring reports.
• Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.
• Assists with the organization and management of internal meetings, investigator meetings and other trial specific meetings as required.
• Mentor junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
• Performs other work-related duties as assigned.
• Other Requirements
• BA/BS or higher in a scientific field.
• Minimum of 4 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.
• Experience in interactions with outside vendors (CROs and other vendors) is preferred

Contact: rbohra@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.