Novan
  • 06-Nov-2017 to 05-Jan-2018 (CST)
  • Morrisville, NC, USA
  • Part Time

Purpose:

The Clinical Research Associate is responsible for monitoring clinical trials in compliance with Good Clinical Practices (GCP) and relevant Standard Operating Procedures (SOPs). The Clinical Research Associate will work with Sponsor and CRO clinical operations staff and clinical research sites to facilitate study enrollment. This position will also confirm the accuracy of study data, supervise the conduct of clinical trials, build effective site relationships, and ensure sites are properly managed and compliant with applicable regulations. The Clinical Research Associate shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.  

 

Principal Responsibilities and Accountabilities:

  1. Perform duties on time, and within the Company's normal business hours listed in the Employee Handbook. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues. Presents a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
  2. Independently conduct and co-monitor all types of visits including: qualification, initiation, interim and closeout.
  3. Participate in project team training and Investigator or Study Coordinator training.
  4. Assist with study document collection and retrieval as needed.
  5. Participate in monitoring activities of study data verification of source documentation and case report forms (CRFs) to ensure compliance with the study protocols, GCPs, and SOPs. Ensure data discrepancies are identified and resolved. Write co-monitoring reports and assist in review of CRO monitoring reports.
  6. Identify project risks and work with the clinical operations teams to identify the need for new/modified processes.
  7. Evaluate and escalate decisions impacting the project team and/or broader organization.
  8. Respond to audits and data queries.
  9. Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate.
  10. Adhere to clinical operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.
  11. Monitor patient safety on-site and address protocol violations. Perform site facilities inspection.
  12. Conduct on-site study-specific training.
  13. Perform other duties as may be assigned from time to time.

 

Qualifications:

Education:  

  • BS in nursing, public health, science or a related discipline required. Masters Degree preferred.

 

Experience:

  • Minimum 5 years Clinical Trial experience in CRO, biotechnology or pharmaceutical industries.
  • At least 2 years of independent clinical monitoring, including qualification, initiation, interim, and close-out.
  • Acne or other dermatology experience preferred.
  • Strong knowledge of regulatory and ICH/GCP guidelines.

 

Skills:

  • Honest, flexible, dependable, self-motivated team player with a strong work ethic and exceptional interpersonal communication skills to communicate both verbally and in writing with internal and external clients.
  • Effectively prioritizes workload and manages time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced, interruption-driven environment.
  • Excellent organizational skills and ability to prioritize a variety of tasks.
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
  • Ability to travel domestically and internationally up to 60%.
  • Strong computer skills with proficiency using MS Office software: Excel, Word, and PowerPoint required.
  • Motivated self-starter who is detail oriented and able to work both independently as well as part of a team.The qualified applicant shall demonstrate: a) sound reasoning; b) progressive learning agility; c) versatility or being capable of doing many things competently; and, d) resilience from a disappointment or setback.
  • Values achieving milestones, including team and company goals. 

 

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours. Frequent travel may be required (60%).

 

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

 

Novan, Inc. is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

Novan
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