The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Pharmaceutical Company is seeking a Clinical Research Coordinator in North Charleston, SC.
Roles & Responsibilities
The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.
In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
• Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines:
• Screening of patients for study enrollment
• Patient consents
• Patient follow-up visits
• Documenting in source clinic charts
• Entering data in EDC and answering queries
• Obtaining vital signs and ECGs
• May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up
• Requesting and tracking medical record requests
• Updating and maintaining logs, chart filings
• Maintaining & ordering study specific supplies
• Scheduling subjects for study visits and conducts appointment reminders
• Building/updating source as needed
• Conducting monitoring visits and resolves issues as needed in a timely manner
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner
• Filing SAE/Deviation reports to Sponsor and IRB as needed
• Documenting and reporting adverse events
• Reporting non-compliance to appropriate staff in timely manner
• Maintaining positive and effective communication with clients and team members
• Always practicing ALCOAC principles with all documentation
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF
• Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed
• May set up, train and maintain all technology needed for studies.
• May assist with study recruitment, patient enrollment, and tracking as needed\
• Maintaining confidentiality of patients, customers, and company information, and performing all other duties as requested or assigned.
Skills & Requirements
• 2+ years of experience as a Clinical Research Coordinator
• Direct site experience (coming from a CRO environment tends to not be successful)
• Experience in a high-volume environment
• Strong understanding of core clinical research fundamentals and study conduct
• Bachelor's or equivalent experience
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1145171
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