Required: Three (3) years current experience in acute care hospital, medical center, health system or related industry
Preferred: Previous experience with clinical trials
Reports To: Manager-Research and Clinical Trials
Supervises: N/A
Ages of Patients: Adult, Geriatric
Blood Borne Pathogens: Minimal/No Potential
Skills, Knowledge, Abilities:
Essential Responsibilities
Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
Recruits, educates, consents, schedules, and completes follow-up with patients/subjects.
Participates in the design, planning and conduct of clinical trials program and clinical research projects.
Performs pre-investigation, initiation and 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 standard operating procedures (SOP).
Assists in writing and/or auditing clinical reports.
Assists in developing protocols, case report forms, and informed consent documents.
Works closely and acts as a liaison between sponsors, Contract Research Organization (CRO) sites and other department staff members.
Manages the negotiation and monitoring of budgets and contracts; formulates study budgets utilizing the protocol, manuals, study plan and resource needs assessment for the study; develops and supports the development of tools and training to aid in the development of study budgets, coverage analysis, tracking of invoiceable term items and research billing.
Performs clinical site activities (regulatory issues, patient accrual, patient scheduling and care coordination, data capture and monitoring, adverse events reporting).
Develops sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants and provide consultation/expert advice to leadership.
Develops or contributes to the development of SOPs, best practices, tools, processes and training to enhance safety and compliance with federal, local and institutional regulations/guidelines.
Manages tracking and reporting Serious Adverse Events (SAEs) and Adverse Events (AEs).
Works with physicians and leadership to develop and implement client trials and research programs; carries out key activities in evaluating, initiating, operationalizing and conducting clinical trials.
Works closely with physicians and staff to facilitate research and enrollment to research studies and clinical trials.
Prepares and presents materials to Institutional Review Board (IRB); investigates and resolves problems and complaints; develops corrective and preventative action plans.
Develops educational/promotional materials to educate patients on available programs and clinical trials; develops and maintains a formal mechanism to ensure that information about the availability of clinical trials is provided to patients.
Works to accrue and monitor cases enrolled in program and clinical trials; reports to governing Committee.
Coordinates performance improvement activities as they relate to clinical trials and research.
Provides support to investigators and maintain screening, enrollment, compliance, statistics on program and trials. Involved in planning long or short term objectives that support research program.
Develops and implements Education Program for the
Benefits
Health insurance
Additional Information
Default Work Shift:
Varies (United States of America)
Hours:
0
Salary range:
$37.00
Schedule:
Per Diem
Shift Hours:
8 Hour employee
Department:
Research-Oncology
Job Objective:
Coordinates and implements clinical research activities.
Job Description:
Education:
Required: Bachelor's degree in healthcare and/or related field; completion of following CITI Program courses: Good Clinical Practice (GCP) Course, Clinical Research Coordinator Foundations, Clinical Research Coordinator Advanced
Preferred: Master's degree
Licensure/Certification:
Preferred: ACRP CCRC or SOCRA CCRP Certification; certification required upon eligibility
Eisenhower · Eisenhower Medical Center