Clinical Research Coordinator-Per Diem

Eisenhower Medical Center; United States; On-site; USD 44,000 - 59,000; Full time

Job summary

Eisenhower Medical Center is seeking a Clinical Research Coordinator to coordinate and implement clinical research activities. A Bachelor’s in healthcare or related field is required, with GCP/CITI training and experience coordinating trials in an acute care setting.

Preferred: Master’s degree and ACRP/SOCRA certification eligibility. The role involves recruitment, consent, scheduling, monitoring, data management, and collaboration with sponsors, CROs, and researchers.

Qualifications

• Bachelor’s degree in healthcare and/or related field required; GCP course and clinical research coordination coursework completed.
• Clinical research coordination foundations and advanced course completion preferred.
• Master’s degree preferred.

Responsibilities

• Demonstrates compliance with Code of Conduct and compliance policies, and resolves compliance questions or concerns and reports suspected violations.
• Recruits, educates, consents, schedules, and completes follow-up with patients/subjects.
• Participates in design, planning and conduct of clinical trials program and clinical research projects.
• Performs pre-investigation, initiation and periodic monitoring visits to ensure protocols, obligations, and regulations are followed.
• Monitors subject records for quality, data integrity and SOP compliance.
• Assists in writing and/or auditing clinical reports.
• Assists in developing protocols, case report forms, and informed consent documents.
• Leads liaison between sponsors, CRO sites and department staff.
• Manages budgets and contracts; develops study budgets and tracking tools.
• Performs clinical site activities (regulatory, patient accrual, scheduling, data capture, AE reporting).
• Develops clinical trial expertise to advise leadership.
• Develops SOPs and training to enhance safety and regulatory compliance.
• Manages tracking and reporting of SAEs and AEs.
• Works with physicians/leadership to implement client trials and research programs.
• Assists in planning education materials and community outreach for trials.
• Develops and maintains information on trial availability for patients.
• Coordinates performance improvement activities related to trials.
• Provides support to investigators with screening, enrollment, compliance, statistics.
• Develops and implements Education Program for the community.
• Performs other duties as assigned.

Skills

Data analysis

Project coordination

Interpersonal skills

Time management

Microsoft Office

Independent work

Education

Bachelor's degree

Master's degree (preferred)

Tools

Microsoft Office Suite

Job description

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.

Education

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

Licensure/Certification: Preferred: ACRP CCRC or SOCRA CCRP Certification; certification required upon eligibility

Experience

Experience: 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

Reports To: Manager-Research and Clinical Trials

Supervises

Supervises: N/A

Ages of Patients

Ages of Patients: Adult, Geriatric

Blood Borne Pathogens

Blood Borne Pathogens: Minimal/No Potential

Skills, Knowledge, Abilities

Skills, Knowledge, Abilities: Ability to collect, analyze and disseminate data, Ability to coordinate multiple projects, Ability to create and maintain positive interpersonal relations with peers, staff, leaders and vendors, Ability to prioritize tasks and manage time efficiently to meet deadlines, Ability to use Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and other relevant software applications, Ability to work independently and as a team member, Knowledge of good clinical practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects, Understanding of relevant technologies and tools pertinent to the job role, Written and verbal communication skills.

Essential Responsibilities

• 1. Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
• 2. Recruits, educates, consents, schedules, and completes follow-up with patients/subjects.
• 3. Participates in the design, planning and conduct of clinical trials program and clinical research projects.
• 4. Performs pre-investigation, initiation and periodic monitoring visits to assure that the protocol, obligations, responsibilities, and regulations are established and followed.
• 5. Monitors subject records for quality, data integrity and compliance with regulations and organization’s standard operating procedures (SOP).
• 6. Assists in writing and/or auditing clinical reports.
• 7. Assists in developing protocols, case report forms, and informed consent documents.
• 8. Works closely and acts as a liaison between sponsors, Contract Research Organization (CRO) sites and other department staff members.
• 9. 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.
• 10. Performs clinical site activities (regulatory issues, patient accrual, patient scheduling and care coordination, data capture and monitoring, adverse events reporting).
• 11. Develops sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants and provide consultation/expert advice to leadership.
• 12. 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.
• 13. Manages tracking and reporting Serious Adverse Events (SAEs) and Adverse Events (AEs).
• 14. 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.
• 15. Works closely with physicians and staff to facilitate research and enrollment to research studies and clinical trials.
• 16. Prepares and presents materials to Institutional Review Board (IRB); investigates and resolves problems and complaints; develops corrective and preventative action plans.
• 17. 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.
• 18. Works to accrue and monitor cases enrolled in program and clinical trials; reports to governing Committee.
• 19. Coordinates performance improvement activities as they relate to clinical trials and research.
• 20. 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.
• 21. Develops and implements Education Program for the community, including materials and lectures.
• 22. Performs other duties as assigned.

Welcome to Eisenhower Health Careers! Eisenhower has been a leader in health care for the Coachella Valley since we opened our medical center in 1971. Since then, we’ve been growing steadily, adding services, capabilities and facilities to anticipate and meet the needs of our expanding area. Today, the Eisenhower name extends far beyond the state-of-the-art care we deliver at the hospital.