- Directs the activities of multiple workers engaged in clinical research projects to ensure compliance with protocols, overall business, and clinical operations.
- Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory and institutional polices.
- Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
- Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
- Records adverse event 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 specially designated review groups.
- Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
- 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.
- Directly manage customer satisfaction of all key stakeholders (patients, CRAs, Sponsors and business clients).
- Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, and documentation procedures.
- Provides management with performance feedback on employees engaged in assigned projects.
- Collaborates with investigators 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 studies affairs and issues.
- Orders drugs, devices, equipment, supplies necessary for study completion.
- Solicits industry-sponsored trials through contacts and professional organizations.
- Knowledge of biological and medical terminology.
- Understanding of the principles of administration and management.
- High School Diploma
- Or a degree in nursing or health related field
- And 1- 5 years of on-the-job training as clinical research assistant or research study coordinator
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 20 pounds at times.
- Travel to Sponsor required meetings as needed.
- Exposure to human bodily fluids
- Occasional night and weekend work schedules
- Work is normally performed in a typical interior clinical/office environment.
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Clinical Research Coordinator - Montclair, United States - American Composites LLC
4 weeks ago
Description
Catalina Research Institute (CRI), an ACRS company is located in Montclair, CA and they focus on Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a Clinical Research Coordinator.
LOCATION: On site in the Montclair, CA office
SUMMARY
The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate, analyze clinical data and exercise discretion and independent judgment with matters of significance.
RESPONSIBILITIES:
REQUIREMENTS
EDUCATION
PHYSICAL REQUIREMENTS AND OR ENVIRONMENTAL FACTORS
About ACRS
American Clinical Research Services (ACRS) Holdings was founded to improve the quality of life for millions of Americans through scientific research. Given the challenges in patient recruiting and the increased complexity around clinical trials, ACRS is focused on the opportunity to achieve efficiencies in a highly fragmented sector.
All employees must be authorized to work in the United States. ACRS provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
