PS Clinical Research Coord

University of Utah; Salt Lake City (UT); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Research Coordinator to oversee the implementation and quality control of research studies. In this vital role, you will assist the Principal Investigator in achieving study objectives while ensuring compliance with regulatory guidelines. You'll manage study documentation, develop budgets, and promote participant enrollment. This position offers a unique opportunity to contribute to innovative research in a dynamic office environment, where your organizational and communication skills will be paramount. If you're passionate about health sciences and eager to make an impact, this role is for you.

Qualifications

• Bachelor's degree in health sciences or related field with two years of research experience.
• Exceptional organizational, communication, and human relations skills.

Responsibilities

• Oversees compliance to protocol and manages quality control of study documentation.
• Develops study budgets and monitors expenses for research projects.
• Handles responsibilities related to research participants, including recruiting and scheduling.

Skills

Organizational Skills

Communication Skills

Human Relations Skills

Knowledge of GCP

Knowledge of FDA Regulations

Knowledge of HIPAA

Knowledge of IRB Regulations

Education

Bachelor's Degree in Health Sciences

Nursing Degree (Preferred)

Job description

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Job Summary

Coordinates the implementation, quality control, and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

Responsibilities

1. Oversees compliance to protocol; manages quality control, completion, and submission of study-related documentation; prepares reports for organizations and agencies.
2. Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedules with sponsors and fees for internal services.
3. Monitors enrollment goals; develops strategies to promote enrollment and participant compliance; handles responsibilities related to research participants, including developing informed consents, screening, recruiting, scheduling visits, and acting as a liaison.
4. Recognizes, tracks, and reports adverse events and protocol deviations.
5. Prepares for and coordinates site visits by sponsors or federal agencies.
6. Represents the research program at meetings and research consortia.
7. Prepares, submits, and maintains regulatory documents and research correspondence.
8. Contributes to developing educational materials and educates the community and research professionals.
9. Supervises, mentors, and trains new or junior research staff.
10. Coordinates with referring physicians regarding research projects and maintains referral networks.
11. Develops and maintains patient databases, logs, and records of drugs, devices, and procedures.
12. Assists in developing study protocols.

This description is not exhaustive of all duties and responsibilities.

Work Environment and Physical Requirements

Office environment; occasional exposure to infectious diseases and oils; frequent hearing, listening, talking, repetitive hand motions, walking, standing, sitting; occasional bending and reaching overhead.

Minimum Qualifications

• Bachelor's degree in health sciences or related field or equivalent, with two years of research experience and completion of University RATS Clinical Certification within one year of hire.
• Exceptional organizational, communication, and human relations skills.
• Knowledge of GCP, FDA, HIPAA, IRB regulations; ability to work independently.
• Additional training or certifications may be required by departments.
• Nursing degree and research compliance certification are preferred.
• Must meet immunization requirements per CDC standards.

Preferences

Additional preferred qualifications and skills may be specified by the department.