Clinical Research Coordinator (CRC)
Genesis Clinical Research is seeking a full time, Clinical Research Coordinator to join our Clinical Research program. Spanish speaking is preferred but not required. Employee will be responsible for conducting trials within area dialysis centers and within inpatient phase 1 setting. Salary and benefits are competitive. Clinical Research experience is preferred but not required. Hours can range but are typically normal business hours.
Preferred Qualifications:
- Two years professional research experience preferred.
- Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
- Bilingual (Spanish) preferred.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Assists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collection.
- Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegation.
- Ensures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to: informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights and responsibilities.
- Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI to ensure subject safety.
- Accurately documents study subject activities as outlined by the protocol.
- Maintains documents according to applicable HIPAA and regulatory requirements.
- Implements study-specific quality goals and practices.
- Troubleshoots protocol, and strategizes with all participants at every level of the study in order to assure quality study outcomes.
- Adheres to GCP and all regulatory practices as established by law and company policies and procedures.
- Coordinates logistics of activity for multiple, concurrent studies at multiple study sites.
- Coordinates with facility or practice manager to educate new clinical staff on study specific responsibilities and protocol tasks.
- Maintains mandatory training requirements according to guidelines/conditions set by, for example, the International Air Transport Association (IATA), GCP, etc.
- Facilitates positive relationships with Medical Director and appropriate management.
- Supports physicians by communicating initiatives, policies and procedures.
- Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
- Completes study subject records in an accurate and timely completion of all applicable study subject records.
- Travels between primary site to and from dialysis centers as needed to perform patient visits.
- Other duties as assigned.
Job Type: Full-time
Pay: $41,358.00 - $50,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: Multiple locations
