Clinical Research Coordinator The Jones Center for Diabetes and Endocrine Wellness Macon, GA Job Details Full-time From $20 an hour 1 hour ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications Teamwork Clinical research HIPAA Filing Employee relationship building Attention to detail Organizational skills Full Job Description
THIS POSITION IS 100
%
ONSITE AND IS NOT A REMOTE OR HYBRID POSITION
Overview The Clinical Research Coordinator (CRC) is responsible for overseeing various aspects of clinical research studies from enrollment through closeout. The CRC will manage the day-to-day responsibilities of enrolling participants into clinical research studies, ensuring enrollment goals are met and data entry and query resolution are completed in a timely manner. The CRC will work in close proximity with the Associate Director of Clinical Research, the Investigators, and other Research Staff, and sponsor/CRO representatives to carry out the clinical trials within the organization. Responsibilities Understand the recruitment plan, assist senior level CRCs to lead pre-screening and recruitment efforts, and ensure enrollment goals are met for each assigned trial. Speak to potential participants to gauge their interest in participating in a trial. Create and update source documents for assigned trials Schedule participants for study visits, ensuring scheduling occurs in the CTMS and EMR. Travel to and attend Investigator Meetings, conferences, and other research-related meetings, as requested. Assist the PI by creating training logs and materials to ensure all staff and investigators are properly trained and delegated prior to completing any trial-related tasks. Review and understand each assigned protocol, including the Inclusion/Exclusion Criteria, study visits, timelines, and be able to navigate the protocol for vital information when needed. Assist the PI with maintaining documentation of IP inventory for each assigned trial. Maintain adequate inventory of study supplies. Build rapport with study participants to encourage compliance with study procedures and facilitate retention throughout the entire duration of the study. Enter all visits and invoiceable items into the CTMS in a timely manner. Work closely with investigators, ensuring they are kept up to date on participants. Act as a liaison between the investigator and the sponsor, ensuring all communications and information are relayed to the investigator with quick turnaround responses to the sponsor when information is requested. Prepare and submit documents and reports to the Institutional Review Board (IRB) as required by the protocol and federal regulations and guidelines. Perform study tasks as delegated on the Delegation of Authority Log for each trial, including, but not limited to: Obtaining and recording medical history, concomitant medications, Adverse Events and Serious Adverse Events, vital signs; performing all clinical and administrative tasks related to visits Deliver high quality data by completing source documents accurately and fully at each participant's visit. Complete data entry and resolve queries in a timely manner. Request, review, and extract information from medical records throughout the trials Accurately record and register participants and their information into the study systems such as the Interactive Response Technology (IRT) and Electronic Data Capture (EDC) systems. Coordinate interim monitoring visits and closeout visits, ensuring all data, source, and regulatory items are completed, filed, and available for sponsor/CRO representatives, and ensuring that the PI is available to meet with the sponsor/CRO representative at each visit. Review Interim Monitoring Visit Follow-up Letters and correspondence from sponsors/CROs, complete action items, and communicate professionally and responsively to sponsor/CRO representatives throughout the trial in a timely manner. Report delays, issues, or problems as they occur for assigned trials to the Associate Director of Clinical Research, helping to formulate a solution to reported delays, issues, or problems. Cooperate with compliance efforts and report instances of non-compliance to the Associate Director of Clinical Research Upload, file, and maintain eISF for each assigned trial, ensuring documents are kept current and files are complete. Prepare for and participate in inspections, audits, and other regulatory checks by sponsors, CROs, and other regulatory agencies. Provide mentoring to Research Assistants Participate in company training and meetings, as needed. Support and model teamwork and a positive work environment at the site(s). Perform other job-related duties as requested and required. Skills Superior communication and organizational skills Extensive knowledge of medical terminology Knowledgeable and experienced with Good Clinical Practice, ICH Guidelines, and HIPAA within clinical trials Strong work ethic and ability to quickly establish rapport with participants, investigators, and sponsor/CRO representative. Proficient in the use of Microsoft Office Suite Meticulous attention to detail with the ability to multi-task Capable of establishing and maintaining working relationships with colleagues, patients, sponsors, and other clients Join us in our mission to drive innovation through research!
Job Type:
Full-time Pay:
From $20.00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Application Question(s): Are you located in Middle Georgia?
