**Clinical Research Coordinator Position in Atlanta, GA**
Must have previous Clinical Research Coordinating Experience
Job Overview
The role of the Clinical Research Coordinator entails executing assigned tasks, including protocol-mandated visit procedures, the administration of questionnaires and subject material, as well as the dispensation of medication. The incumbent will operate within regulatory guidelines and contribute to subject recruitment efforts under the supervision of the study's Principal Investigator. Effective engagement with Principal Investigators, pharmaceutical companies (Sponsors), contract research organizations (monitors), and research subjects is crucial for success in this role.
Job Responsibilities:
Protocol Understanding:
- Read and comprehend assigned research protocols.
- Conduct prescreening of potential patients.
Site Staff Training:
- Train site staff on the study's purpose.
- Record attendance during training sessions.
Resource Management:
- Assess and determine required resources for the study.
- Ensure the availability of necessary resources for effective study deployment.
Enrollment Management:
- Use the Electronic Medical Record (EMR) to screen eligible patients.
- Facilitate patient qualification discussions with the Principal Investigator.
- Obtain and document informed consent following ICH/GCP and site SOPs.
- Ensure timely and accurate data entry based on the ALCOA principle.
Monitoring Visit Preparation:
- Organize and maintain all Source Documents for easy access.
- Resolve outstanding items from previous monitoring visits.
- Address and close any queries from prior visits.
- Keep temperature and accountability logs readily available.
Ongoing Study Oversight:
- Plan subject visits as per protocol-specific schedules.
- Prevent protocol deviations related to out-of-window procedures.
- Coordinate with location administration to ensure space and resource availability.
- Report Adverse and Serious Adverse Events to IRB and Sponsor following guidelines.
- Dispense/collect study medication with accurate Investigational Product accountability.
- Collect and process subject laboratory specimens following protocol.
- Complete case report forms (CRFs) and other patient tracking information accurately and promptly.
- Maintain a comprehensive understanding of all data collection instruments and ensure accurate data collection according to the protocol.
General Responsibilities:
- Perform additional duties and responsibilities as required, assigned, or requested.
Functional and Technical Proficiencies
(Specialized skills, knowledge, and abilities required for essential role functions)
- We seek a self-motivated individual committed to ensuring patient safety, achieving enrollment targets, timely data entry of high quality, and strict adherence to Good Clinical Practice (GCP).
- Strong interpersonal and communication skills, flexibility, exceptional organizational abilities, and attention to detail are prerequisites. Knowledge of and adherence to GCP, IATA, and FDA regulations is essential.
- The ability to perform basic clinical procedures such as blood work, vitals, height, weight, ECG, and multitasking across multiple studies is required. The candidate should be open to working a flexible schedule.
Education/Training and Certification Requirements
(Minimum educational qualifications required for essential job duties)
- A Bachelor's degree is a prerequisite, with a preference for Nursing or Health Science backgrounds.
Additional Details:
- Location: Atlanta, GA (30308)
- Hours: Monday-Friday; Normal Business Hours; Onsite 5 Days a week
- Employment: Direct Hire Opportunity
- Salary: $60,000-$75,000 (Dependent on background and years of experience)