Job Description
Where compassion meets innovation and technology and our employees are family.
Thank you for your interest in joining our team! Please review the job information below.
This position is 100% onsite. GENERAL PURPOSE OF JOB: The Clinical Research Coordinator (CRC) assists in the conduct of clinical trials under the guidance of senior research staff and collaborates with investigators, clinical staff, research organizations, and sponsors to efficiently conduct and coordinate clinical research activities. They coordinate the screening, enrollment, and data reporting for patients enrolled in clinical research studies, serve as protocol resources for clinical staff caring for patients on-study, and serve as a back-up for other research staff. The CRC has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. The CRC makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practice (GCP), and with applicable sponsor and regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is not intended to be all-inclusive; employees will perform other reasonably related business duties as assigned by the immediate supervisor and/or hospital administration as required.
- Maintains utmost level of confidentiality at all times.
- Adheres to hospital policies and procedures.
- Demonstrates business practices and personal actions that are ethical and adhere to corporate
- Serves as point of contact for sponsors, clinical staff, and others involved in clinical research studies.
- Assists in the recruitment of participants for clinical research studies and distributes study information as needed
- Ensures accurate tracking of completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate for billing purposes.
- Develops goals annually to address the specific departmental needs
- Attends and participates in department and hospital meetings as required
- Verifies study eligibility and study enrollment requirements
- Obtains consent/assent for research participation in accordance with applicable federal, state, and local regulations and institutional policies/procedures
- Facilitates study visits and ensures all procedures are conducted in compliance with the clinical protocol and standard operating procedures (SOPs)
- Ensures that data collected by staff are complete and verifiable from source documents
- Helps create source document templates in accordance with the protocol, case report forms, and electronic data capture systems.
- Collaborates with pharmacists, re: drug inventory, storage and monitoring requirements, subject visits and dispensing
- Collaborates with clinical staff and ancillary departments for protocol training and scheduling and care for enrolled subjects
- Collects and submits study data within sponsor-required timelines
- Coordinates with laboratory personnel to collect and ship specimens to study central laboratories in accordance with protocol requirements
- Schedules, coordinates, and participates in site selection visits, study initiation visits, and monitoring or inspection visits which may include facility tours and document compilation and verification.
- Maintains research charts for study participants in accordance with DCH guidelines.
- Ensures compliance with protocol related treatments and evaluations by maintaining a quality assurance process and assisting the PI and Program Manager with designing and implementing process improvement as needed
- When needed, assists in the preparation of documents for Institutional Review Board submission including informed consent, protocol amendments and safety reports.
- Assists with development of department SOPs; provides suggestions for improvement
- Practices and promotes cost-effective use of resources and makes recommendations for improvement
- Promotes exceptional customer service and support of the plan of care per protocol
- Self-directed in developing their own performance in relation to professional standards, certifications, and sponsor and site required training.
- Performs other duties as necessary
EDUCATION AND/OR EXPERIENCE: - Bachelor of Science degree in a science discipline from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience
CERTIFICATES, LICENSES, REGISTRATIONS. - Society for Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification following 2 years of employment.
- Obtain AHA Basic Life Support upon hire and maintain current qualifications.
ADDITIONAL INFORMATION: - Must be proficient in Microsoft Office applications
- Fluency in Spanish (speaking, listening, reading, writing) is strongly preferred.
Job Tags
Full time, Local area, Immediate start,