Clinical Research Coordinator - Full Time - Day Shift - AGH

Highmark Health; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; Full time

Job summary

Highmark Health is seeking a Clinical Research Coordinator to plan, coordinate, and manage clinical trials across sponsored studies. You will ensure compliance with GCP, regulatory requirements, and study protocols while educating patients and families about participation and risks.

The role involves coordinating data collection, regulatory binder management, and ongoing monitoring to safeguard participant safety and data integrity in a dynamic hospital setting.

Qualifications

• Minimum Associate's degree, RN, or equivalent research experience.
• 1-3 years' related experience.
• Preferred Bachelor's Degree.
• Certification from AC RP/ SOCRA (CCRP) preferred.
• Driver's license may be required depending on facility requirements.

Responsibilities

• Identify patients eligible for clinical trials and interface with clinical staff.
• Provide in-service education to hospital personnel involved in the investigational study.
• Educate patients and families about investigational studies and participation requirements; obtain written consent and monitor per protocol.
• Collect, maintain, and store all relevant clinical data, case report forms, and regulatory binders.
• Plan, coordinate, and manage activities for clinical trials ensuring patient safety, GCP, and protocol/regulatory compliance.
• Perform other duties as assigned.

Skills

Clinical research coordination

Regulatory compliance

Patient education

Data collection

Education

Associate's degree, RN, or equivalent

Bachelor's degree preferred

Job description

GENERAL OVERVIEW:

This job plans, coordinates, and manages the activities associated with the initiation and completion of clinical trials, sponsored by internal, industry, foundation, and/or Federal funding sources. Maintains compliance with all regulatory bodies associated with human subject research.

ESSENTIAL RESPONSIBILITIES:

• Interfaces with clinical staff to identify patients eligible for clinical trials. (30%)
• Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (30%)
• Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent. Completes required follow-up and active patient monitoring per study protocol. (30%)
• Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (15%)
• Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies. (15%)
• Performs other duties as assigned or required. (10%)

QUALIFICATIONS:

Minimum Associate's degree, RN, or equivalent research experience. 1-3 years' related experience. Preferred Bachelor's Degree. Current research-related certification from accredited program such as The Association of Clinical Research Professional (ACRP), e.g. Certified Clinical Research Coordinator (CCRC), ACRP Certified Professional (ACRP-CP) or The Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professionals (CCRP). Driver's license may be required depending on facility requirements.

Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.

Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies. As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.

Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law.

California Consumer Privacy Act Employees, Contractors, and Applicants Notice Highmark Health is a national, blended health organization that includes one of America's largest Blue Cross Blue Shield insurers and a growing regional hospital and physician network. Based in Pittsburgh, Pa., Highmark Health's 35,000 employees serve millions of customers nationwide through the nonprofit organization’s affiliated businesses, which include Highmark Inc., Allegheny Health Network, HM Insurance Group, United Concordia Dental, HM Health Solutions and HM Home & Community Services.