A Clinical Research Coordinator oversees multiple aspects of clinical trials. A Clinical Research Coordinator ensures compliance with protocols, regulations, and ethical standards.
Who are we?
Elixia is a trusted clinical site organization, providing industry-leading patient recruitment and clinical trials management and analysis for Cardiology/Nephrology, Behavioral Health and Infectious Disease – not just for a single trial, but across your entire therapeutic pipeline.
Skills/Qualifications:
- Ability to work in a fast-paced environment.
- Able to multi-task.
- Excellent ethical standards, conduct, and GCP compliance
- Self-motivated, willing and able to learn new knowledge and skills.
- Excellent organizational and communication skills
- Reliable, responsible, and accountable
- Flexibility in work schedule when possible must be maintained to ensure coverage of study responsibilities.
- Respect for patients and co-workers
- Bilingual - a plus
- Excellent computer skills.
Responsibilities:
- Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies;
- Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms;
- Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed;
- Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals;
- Oversees subject enrollment to ensure that informed consent is properly obtained and documented;
- Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies;
- Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups;
- Creates source documents as assigned, such as regarding protocols, memos, patient participation;
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports;
- Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks;
- Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures;
- Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions;
- Communicates with laboratories or investigators regarding laboratory findings;
- Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research;
- Orders drugs or devices necessary for study completion;
- Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed;
- Occasional travel to Company sites, Investigator meetings, and/or Company meetings; and
- Performs other duties as assigned, including duties routinely performed by the Company’s Research Assistants.
This Job Description is not an exhaustive list of all responsibilities that you may be required to perform. The Company reserves the right to revise this job description at any time.
Required experience:
- One (1) year of clinical experience
- Previous Clinical Research experience preferred.
- Bilingual - preferred
Benefits
We passionately believe that our employees are the heartbeat of our organization and we are happy to offer the following benefits:
- Health insurance
- Dental Insurance
- Vision Insurance
- PTO
- Paid Holidays
- Life Insurance
- 401K
- Benefit eligibility is dependent on employment status.
Job Type: Full-time
The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.
Job Type: Full-time
Pay: $24.00 - $26.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed
License/Certification:
- Good Clinical Practice (Required)
- IATA Certification (Required)
Ability to Commute:
- Saint Peters, MO 63376 (Required)
Ability to Relocate:
- Saint Peters, MO 63376: Relocate before starting work (Required)
Work Location: In person