Senior Clinical Research Coordinator

North Charleston, SC

Kelly Science and Clinical is hiring a permanent Senior Clinical Research Coordinator for one of our clients who is focused on bringing clinical trial opportunities involving life-changing treatments and vaccines to all patients, especially those from under-represented communities. Our client specialize in a range of conditions across psychiatry, neurology, dermatology, and infectious disease therapeutic areas. This is a full time, direct hire opportunity that offers a lot of options on career growth within clinical research. We are hiring various levels of clinical trail coordinators from 2+ years to 5+ years of experience. This Senior CRC will need to be onsite in North Charleston SC.

The Senior Clinical Research Coordinator works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

CRC II reports to Site Manager/Director
FLSA Status: Non exempt

Essential Job Duties:
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; o Patient consents;
• Patient follow up visits; o Documenting in source clinic charts;
• Entering data in EDC and answers 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; o 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; o Filing SAE/Deviation reports to Sponsor and IRB as needed;
• Documenting and reporting adverse events; o Reporting non compliance to appropriate staff in timely manner;
• Maintaining positive and effective communication with clients and team members;
• Always practicing principles with all documentation;
  • Complete all needed activities for study start up, including completing required training, uploading / printing certificates to file in ISF, etc.;
  • 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.
  
  

Minimum Qualifications:

• A Medical Assistant diploma, LPN/LVN or EMT credential AND 5+ years of clinical research coordinator experience
• Bilingual English / Spanish proficiency is a plus.
• BLS certified preferred.
• Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently 40+ wpm
• Strong organizational skills and attention to detail.
• Well developed written and verbal communication skills.
• Well developed interpersonal and listening skills and the ability to work well independently as well as with co workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self motivated, and have a strong work ethic.
• Must possess a high degree of integrity and dependability and ability to work under minimal supervision, identify problems

#P2

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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