The role is responsible for recruiting, screening, and enrolling patients in clinical trials while ensuring strict protocol compliance. It involves coordinating participant visits, documenting assessments, and maintaining regulatory documents in accordance with GCP and SOPs.
Requirements summary
An associate degree in a clinical or scientific discipline and at least three years of experience in a related field are required. A bachelor's degree and SoCRA or ACRP certifications are preferred.
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The general pay scale for this position at MOH is $58,798 -$77,435.
The actual hiring rate is dependent on many factors, including but not limited to prior work experience, education, job/position responsibilities, location, work performance, etc.
Job Profile Summary Responsible for recruiting, screening, consenting, and enrolling patient in clinical trials.
CRC II also coordinates and oversees the subject’s visits in accordance with the protocol requirements.
Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers.
Acts as resource for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs.
Compiles and reports protocol activity; accrual data, and financial information.
Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA.
Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
Responsibilities
Job Profile Summary Job Profile Summary Responsible for recruiting, screening, consenting, and enrolling patients in clinical trials.
The Clinical Research Coordinator II (CRC II) also coordinates and oversees participant visits in accordance with protocol requirements.
Duties include, but are not limited to, assuring protocol compliance for all enrolled participants, participating in the informed consent process, conducting ongoing assessments, and documenting in collaboration with physicians and other providers.
Serves as a resource for education and training of clinical staff and assists in problem‑solving complex issues related to implementation of research processes, process improvements, and standard operating procedures (SOPs).
Compiles and reports protocol activity, enrollment data, and financial information.
Ensures research quality by adhering to organizational SOPs, principles of Good Clinical Practice (GCP), and applicable federal, state, and local regulations, including OSHA, CDC, and HIPAA.
Supports and adheres to the company compliance program, including the Code of Ethics and Business Standards.
Job Description
Key Responsibilities Screens potential participants for protocol eligibility. Presents trial concepts and details to participants, participates in the informed consent process, and enrolls participants into clinical trials. Coordinates participant care in compliance with protocol requirements. May disburse investigational product and maintain accountability records. Oversees preparation of orders by providers to ensure protocol compliance. Packages and ships laboratory specimens to central vendors as applicable. Completion of Hazmat and/or IATA training may be required. In collaboration with providers, reviews participants for changes in condition, adverse events, concomitant medications, protocol compliance, and response to study treatment. Thoroughly documents all findings and participates in data collection. Prepares study‑related documentation, including protocol worksheets, adverse event reports, institutional review board (IRB) documents, and annual continuing review reports. Maintains regulatory documents in accordance with organizational SOPs and applicable regulations. May assist with scheduling monitoring and auditing visits, and interact with monitors/auditors as needed. May collaborate with research leadership in study selection processes. Participates in required training and education programs. May contribute to education of clinical staff regarding research procedures. Works with staff to develop action plans and performance improvement initiatives to enhance quality. May compile and report protocol activity, enrollment trends, data entry compliance, and research financial information to practice leadership and providers. May review protocol‑specific billing guides and submit billing information to the appropriate personnel.
Qualifications
Minimum Job Qualifications (Knowledge, Skills & Abilities) Education/Training Associate’s degree in a clinical or scientific discipline required; Bachelor’s degree preferred.
Minimum three years of experience in a clinical or scientific field required.
SoCRA or ACRP certification preferred.
Business Experience Experience with Microsoft Office applications.
Experience working with physicians preferred.
Experience in clinical research preferred.
Specialized Knowledge/Skills Excellent communication skills.
Strong organizational abilities.
Ability to multi‑task effectively.
Strong time‑management skills.
High level of interpersonal skills to interact with individuals at various levels.
Strong attention to detail.
Ability to work in a fast‑paced environment.
May be responsible for basic clinical assessments.
Working Conditions Environment Traditional office and clinical environment.
The work environment characteristics described here represent those an employee may encounter while performing essential job functions.
Reasonable accommodations will be provided as needed.
Exposure to communicable diseases, toxic substances, medical preparations, and other conditions common to a clinical research environment.
Physical Requirements Significant amount of computer‑based work required.
Requires standing and walking for extended periods.
Occasionally lifts and carries items up to 40 lbs.
Requires corrected vision and hearing within normal range.
Reasonable accommodations will be provided to enable individuals with disabilities to perform essential functions.
This description is general in nature and is not intended to list every responsibility.
Other duties may be assigned as needed to meet organizational goals.
