Clinical Research Associate, Medical Device

Kelly Science & Clinical is seeking a CRA for a full-time, contract-to-hire opportunity with a Biotech Company in Roswell, GA. If youre passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Contract Clinical Research Associate

This role is remote with occasional in-office work in a Roswell, GA office.

This contract time frame is approximately nine (9) months to one (1) year with the possiblity 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 and 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:

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

9878757