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:

Responsible for supporting the conduct of clinical research studies in accordance with study protocols, Good Clinical Practice (GCP), federal regulations, institutional policies, and ethical standards. Under the direction of the Principal Investigator the Clinical Research Coordinator (CRC) is responsible for participant recruitment, screening, enrollment, study visits, data collection, regulatory documentation, and study coordination activities. Serves as a liaison among patients, investigators, sponsors, and clinical staff to ensure the accurate, timely, and compliant execution of research protocols.

Job Description:

Education

Required: Bachelor’s degree in healthcare or related field; completion of following CITI Program courses within thirty (30) days of hire: Good Clinical Practice (GCP) Course, Clinical Research Coordinator Foundations Course, Clinical Research Coordinator Advanced Course; courses must be renewed in accordance with institutional policy

Preferred: Master’s degree

Licensure/Certification:

Required: Certification from Society of Clinical Research Associate (SOCRA) as a Certified Clinical Research Professional (CCRP) or Certification from Association of Clinical Research Professionals (ACRP), such as, Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), ACRP Certified Professional (ACRP-CP) within twelve (12) months of eligibility (as determined by SOCRA or ACRP certification requirements)

Experience

Required: Three (3) years current experience in acute care hospital, medical center, health system or related industry

Preferred: Previous experience with investigational new drug (IND) or investigational device exemption (IDE) 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:

Ability to collaborate with clinicians and stakeholders to make timely, informed decisions that support patient care and research objectives, Ability to communicate clinical research information clearly, accurately, and professionally to patients, physicians, sponsors, and multidisciplinary research teams, Ability to demonstrate professionalism by acting with integrity, accountability, responsibility, and excellence while maintaining a professional appearance and fostering effective communication and collaboration, Ability to effectively manage multiple priorities, timelines, and competing responsibilities while demonstrating leadership, critical thinking, diplomacy, conflict resolution, and negotiation skills, Ability to identify challenges, analyze issues, and develop practical solutions while maintaining compliance with research protocols and patient safety requirements, Ability to maintain a high level of accuracy, recognize discrepancies, and identify potential issues before they impact study quality or operations, Ability to review, interpret, analyze, and communicate qualitative and quantitative data accurately and effectively, Ability to take ownership of assigned work, maintain accountability for outcomes, and contribute to a culture of trust, collaboration, and shared success, Ability to work independently, demonstrate initiative, and proactively identify, prioritize, and complete assigned responsibilities with minimal supervision, 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

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.