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- Job Objective: A brief overview of the position.
- Under guidance of the Investigator, this position is responsible for coordination and implementation of Clinical Trials and Research Projects. Responsibilities include safety monitoring and data collection and recording. Clinical Research Assistant will insure compliance with FDA regulations, sponsor guidelines and IRB and Clinical Trials Office Standard Operating Procedures. Basic understanding of safeguarding confidential information is essential. Proficiency in Word processing and spreadsheets is necessary. Excellent interpersonal skills, organizational skills, accuracy, ability to meet timelines and attention to detail are requisite
- Reports to
- Manager, Research and Clinical Trials
- Supervises
- Ages of Patients
- Adolescent
- Adult
- Geriatric
- Blood Borne Pathogens
- Qualifications
- Education
- Required: Bachelor's degree or one (1) year of experience in Healthcare/Research Environment in lieu of degree
- Preferred: Bachelor's degree
- Licensure/Certification
- Required: N/A
- Preferred: Certification from the Society of Clinical Research Associates or the Association of Clinical Research Professionals
- Experience
- Required: One (1) year experience in Healthcare/Research Environment (i.e., Medical Assistant, Research Assistant) or Bachelor's degree in lieu of experience
- Preferred: Previous experience with clinical trials
- Essential Responsibilities
- Demonstrates compliance with Code of Conduct and compliance policies and takes action to resolve compliance questions or concerns and report suspected violations.
- Participates in the complete design, planning and conduct process of clinical research projects, including:
- Performing periodic monitoring visits to assure that the protocol, obligations, responsibilities and regulations are established and followed.
- Monitors subject records for quality, data integrity and compliance with regulations and organization's SOP's.
- Assists in writing and/or auditing clinical reports.
- Works closely with Contract Research Organization (CRO) and other study sponsors staff members.
- Coordinates patient scheduling between research office and clinical sites.
- Manages clinical site activities (regulatory issues, patient accrual, data capture and monitoring, adverse events reporting).
- Acts as liaison between sites, CRO and other departments. Attends to study meetings organized by sponsors, generally at sponsor site, as applicable.
- Develops sufficient product/indication expertise to communicate directly with clinicians, staff, other departments, consultants, etc.
- Assists in tracking and reporting Serious Adverse Events to sites, sponsor.
- Works closely with community based physicians and staff to facilitate research and enrollment to trials.
- Maintains knowledge of data management of IND's and IDE's being utilized.
- Develops and maintains a formal mechanism to ensure that information about the availability of related clinical trials is provided to patients.
- Works with Community Outreach to develop education/promotional materials to educate patients on available clinical trials.
- Works to accrue and monitor cases enrolled in clinical trials.
- Coordinates performance improvement activities as they relate to research and clinical trials.
- Review subject charts and other sources to screen and identify potential subjects for inclusion in study, based on protocol criteria.
- Maintain inventory log of study drugs/services.
- Obtain and handle subject biological specimens for protocol.
- Provides administrative support to physicians and EMC IRB and tracks Clinical Trials.
- Performs other duties as assigned.
Date Posted: 19 March 2024
Job Expired - Click here to search for similar jobs