Clinical Research Associate, Medical Device
: Job Details :

Contract Clinical Research Associate

Kelly Science & Clinical is seeking a CRA for a full-time, contract-to-hire opportunity with a Biotech Company in Roswell, GA. This role is remote with occasional in-office work in a Roswell, GA office. This contract period is approximately nine (9) months to one (1) year with the possibility of subsequent full-time employment.

Overview

Our client is a well-funded startup medical device company early in its development that is seeking an experienced, ambitious, enthusiastic clinical research associate (CRA) to join our growing team. The role of the CRA is to ensure clinical studies are conducted in compliance with FDA regulations and ICH guidelines. The CRA will be involved in all investigational stages of the clinical trial, including identifying site(s); and setting up, initiating, monitoring and closing the trial upon completion or termination. The CRA is encouraged to have strong organizational skills, interpersonal and team participation skills.

Responsibilities

Perform study start up activities which includes the regulatory document collection, review and approval process for IRB submission. Prepare site regulatory binder. Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites. Audit the eTMF to ensure that regulatory documents are complete and accurate and audit ready. Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects. Verify adequacy, completeness, reliability, and quality of trial data collected at study sites. Conduct site qualification, site initiation, interim monitoring and close out visits. Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently. Commute clear, concise information to the sponsor in a timely manner. Participate in the preparation or creation of study related materials. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. The CRA may be assigned other responsibilities as needed. Reporting to and working collaboratively with the Associate Director, Clinical Operations.

Experience

Strong organizational skills, interpersonal and team participation skills are essential. Working understanding of renal and cardiac therapeutic areas and ICU experience is a plus. The CRA must have the ability to effectively operate in a small company environment with potential fast future growth.

Qualifications

Bachelor's degree in life sciences or a healthcare field. 2+ years of relevant experience or an advanced degree with a minimum of 2 years relevant experience, including on-site monitoring. Prior experience in clinical trials with medical devices. Clinical research certification preferred. The ability to perform travel up to an average of 80%, depending on project needs. Extensive experience in clinical research settings. Proficient with scientific software, including clinical trial management systems (CTMS), electronic data capture systems (EDC), and electronic trial master files (eTMF). Proficient with database software such, Microsoft Access, SharePoint and electronic medical records (EMR). Ability to work independently and manage multiple projects. Detail-oriented; able to perform complex tasks with a high degree of accuracy. Superior deductive reasoning, problem-solving, and decision-making abilities. Excellent time management: able to prioritize tasks and accomplish set goals efficiently. Strong written and oral communication skills. This role is home based with minimum visit to the Roswell GA office for in-person activities.

Time Period

This contract period is approximately nine (9) months to one (1) year with the potential for full-time employment.

About Kelly

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsit's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

Diversity and Inclusion

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide.