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CLINICAL RESEARCH ASSOCIATE
Job Title: CLINICAL RESEARCH ASSOCIATE
Job Code: 5571
FLSA: E
Job Level: G1
Revised Date: 05/01/2016
Supervisory Responsibility:
General Description of the Job Class
Develop, coordinate, and implement monitoring strategies essential to the successful management of clinical trials research conducted by Investigators at the Duke University School of Medicine, Duke University Health System, and Affiliates.
Duties and Responsibilities of this Level
CRA I:
Review and demonstrate understanding of various clinical trial protocols.
Participate in site selection and training site personnel regarding the trial; perform site routine monitoring of the trial and follow-up to ensure identified deficiencies are corrected; travel as required.to accomplish responsibilities.
Coordinate the assessment of the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information; conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.
Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, drug accountability procedures, serious adverse events (SAEs), reporting procedures and overall management.
Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of Case Report Forms, source documents, medical records, and regulatory documents.
Follow established guidelines to ensure consistent monitoring of key clinical trial components. This includes but is not limited to investigational agent handling and documentation, timely and accurate data submission, regulatory compliance, and patient care.
Provide feedback to assist sites which includes summary of overall site operations, detected deficiencies and corrective action needed; follow- up with sites until deficiencies are resolved.
CRA II:
In addition to the work performed under the CRA I role, the CRA II will also be responsible for the following:
Develop plans, tools, documents, and standard operating procedures for monitoring clinical trials.
Independently identify when monitoring visits are required based on protocols and policies.
Independently perform assessments of investigative site, and conduct various monitoring visits as detailed above.
Required Qualifications at this Level
Education
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (BSN), Physician Assistant (PA), Nurse Practitioner (NP), or Pharmacist plus three years of healthcare experience; or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of three years closely related research experience.
Experience
Required experience outlined in the education section
Degrees, Licensure, and/or Certification
State of North Carolina license may be required
Knowledge, Skills, and Abilities
N/A
Distinguishing Characteristics of this Level
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
