Lead Study Coordinator

University of North Carolina at Chapel Hill; Chapel Hill (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

The University of North Carolina at Chapel Hill is seeking a Lead Study Coordinator to facilitate oncology clinical trials, manage data and ensure compliance with regulations. Reporting to the Clinical Operations Manager, the Lead Study Coordinator independently manages multiple complex trials through activation, implementation and closure.

As a key team member, you will lead patient care and advising activities, serve as a preceptor for new hires, and provide ongoing training to staff,

Qualifications

• Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols.
• Advanced knowledge of clinical research coordination.
• Strong computer skills.
• Ability to contribute to preparation and delivery of reports, trainings, and SOPs.
• Customer-oriented and team-oriented.
• Ability to communicate effectively and professionally, both verbally and in writing.
• Ability to work on evenings, weekends and/or holidays occasionally required.

Responsibilities

• Lead study coordination across activation, implementation and closure of oncology trials.
• Provide daily team leadership, training and first-line support for staff.
• Ensure patient safety and regulatory compliance per federal and institutional policies.

Skills

ICH GCP knowledge

Clinical research coordination

Strong computer skills

Report & SOP development

Customer-oriented

Team-oriented

Professional communication

Availability evenings/weekends

Education

Bachelor’s degree in a related field

Job description

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC -Chapel Hill offers full-time employees a comprehensive benefits package , paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

Primary Purpose of Organizational Unit

Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research.

Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.

Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.

Position Summary

The purpose of this position is to facilitate the conduct of oncology clinical trials, including subject and data management, according to federal regulations, Good Clinical Practice, and local and institutional policies. Reporting to the Clinical Operations Manager, the Lead Study Coordinator independently manages multiple complex trials through the protocol life cycles of activation, implementation and closure. As Lead Study Coordinator, provide team lead and programmatic support on a daily basis, lead patient care and advising activities and serve as preceptor for new hire; providing ongoing training and first line support for staff. These responsibilities relate to the mission of the UNC / LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact research quality and safeguard institutional integrity.

Minimum Education and Experience Requirements

Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

• Knowledge of ICH GCP , Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols;


• Advanced knowledge of clinical research coordination;


• Strong computer skills;


• Ability to contribute to preparation and delivery of reports, trainings, and SOPs;


• Customer-oriented and team-oriented;


• Ability to communicate effectively and professionally, both verbally and in writing;


• Ability to work on evenings, weekends and/or holidays occasionally required.

Preferred Qualifications, Competencies, and Experience

• Previous experience with clinical research involving tissue, questionnaires, and/or devices


• Experience navigating medical records and data extraction


• Experience with sharing data and specimens amongst multiple institutions


• Three years of clinical trial coordination experience, two of which must be in oncology


• SOCRA / ACRP Certification

Office of Human Resources Contact Information

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at [phone] or send an email to [e-mail]
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

Equal Opportunity Employer Statement

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

Required Documents

• Curriculum Vitae / Resume


• Cover Letter

Optional Documents

• List of References

Supplemental Questions

Required fields are indicated with an asterisk (*).

• * Please select the response below that describes your level of education that best or mostly closely satisfies the education requirements for this position.
  
  
  
  • Bachelor’s degree in required discipline(s) listed or related field
  
  
  • Bachelor's degree in any field/discipline
  
  
  • Master's degree or Doctorate degree in required discipline(s) listed or related field
  
  
  • Master's degree or Doctorate degree in any field/discipline
  
  
  • None of the above
  
  
  
  


• * Do you have knowledge of GCP and ICH Guidelines?
  
  
  
  • Yes
  
  
  • No
  
  
  
  


• * Describe your advanced knowledge of clinical research coordination.
  

  (Open Ended Question)

  
  


• * In your opinion, what are the skills required to be a successful study coordinator?
  

  (Open Ended Question)

  
  


• * Do you currently have any of the following nationally recognized clinical trial certifications: CCRP, CCRC, CCRA, or ACRP-CP
  
  
  
  • Yes
  
  
  • No