Clinical Research Coordinator II - Full-time
Job Title: Clinical Research Coordinator II Position Summary:
The Clinical Research Coordinator II works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
Location: North Charleston, SC
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:
o Screening of patients for study enrollment; o Patient consents;
o Patient follow up visits; o Documenting in source clinic charts;
o Entering data in EDC and answers queries;
o Obtaining vital signs and ECGs;
o 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;
o Requesting and tracking medical record requests;
o Updating and maintaining logs, chart filings;
o Maintaining ordering study specific supplies;
o Scheduling subjects for study visits and conducts appointment reminders;
o Building/updating source as needed; o Conducting monitoring visits and resolves issues as needed in a timely manner;
o 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;
o Documenting and reporting adverse events; o Reporting non compliance to appropriate staff in timely manner;
o Maintaining positive and effective communication with clients and team members;
o 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, 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 2 years of clinical research coordinator experience, OR an equivalent combination of education and experience, is required.
- Proficiency with performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc. is required.
- 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 ;
- Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc 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. 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.
Why Kelly® Science & Clinical?
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 goals—it’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.
About Kelly®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.