Sr Clinical Research Associate

Company: Peachtree Bioresearch Solutions, Inc.
Location: Marietta
Posted on: May 13, 2022

Job Description:

Job Description A remote position responsible for monitoring investigational sites according to project SOPs and GCP/ICH guidelines. They will participate in the design and monitoring of clinical trials, analyze and evaluate clinical data, and ensure compliance with protocol and overall clinical objectives. May be responsible for serving as Lead CRA on a study, dependent on project needs. Responsibilities: Provide support to Project Team and assume additional roles on the team when possible, including Lead CRA role, dependent on project needs Mentor other CRAs within or outside of assigned study Provide input into study documentation and monitoring worksheets Maintain working knowledge of protocols for assigned projects Identify and contact prospective investigational sites Serve as primary contact for assigned sites and maintain close contact with them throughout the study Schedule and conduct pre-study visits, initiation visits, interim monitoring visits and close-out visits Ensure that sites follow protocol requirements and applicable regulations Collect and ensure completeness of all essential regulatory documentation from sites from study start-up through close-out Review case report forms for completeness, accuracy, and legibility and perform source document verification Work with data management and sites to ensure all data queries are resolved Perform study drug accountability during routine monitoring visits Ensure that sites are following AE/SAE reporting procedures per regulatory and study-specific requirements Complete all monitoring reports and follow-up letters in a timely manner Review and approve site monitor visit reports completed by other CRAs Attend study team teleconferences/meetings, as needed Attend investigator meetings and provide support, as needed Make recommendations for improvement in processes to Project Manager/Director Experience: Ideal candidate will have a BS degree and at least 5 years of monitoring experience. Must have knowledge of FDA regulatory requirements, GCP/ICH guidelines, and general medical terminology. Excellent organization and problem solving skills. Ability to work independently, as well as handle a number of diverse projects simultaneously, under tight time constraints. Ability to engage and demonstrate cooperative behavior to support team efforts. Experience in responding rapidly to changing priorities and in managing aggressive deadlines. Excellent written and verbal communication skills. Demonstrated experience in leading and participating in collaborative work teams. Strong leadership abilities and interpersonal skills. Experience in managing multiple tasks.

Keywords: Peachtree Bioresearch Solutions, Inc., Marietta , Sr Clinical Research Associate, Healthcare , Marietta, Georgia