Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
JOB SUMMARY
Reporting to the Clinical Research Manager, the Clinical Research Intern (CRI) will help to coordinate and/or implement his or her assigned duties. In this role, the CRI will assist in the development of an electronic database using REDCap Cloud platform. The CRI may also evaluate and abstract research data while ensuring compliance with research and clinical trial protocol objectives. The CRI may be responsible for completing case report forms, entering data into research databases, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRI may also have limited contact with research subjects as assigned by the Manager. The CRI will be expected to comply with all federal and local agencies including the FDA and the IRB with oversight on the assigned clinical trials.
The Clinical Research Intern (CRI) position is perfect for an individual who is seeking research experience in anticipation of a higher degree in life sciences, particularly nursing (BSN), medical school (MD), physician assistant (PA) or Ph.D. The position would also be perfect for individuals who have experience in building research studies in a data management system or designing eCRFs. The CRI will have day-to-day contact with top medical sub-specialists and researchers in the fields of neurology.
Strives for superior performance by consistently providing a product or service to leadership and staff that is recognized as ultimately contributing to the patient and family experience. Recognizes and demonstrates understanding of patient and family centered care.
This position is for 35 hours a week for 10 weeks, with possibility of extension. This internship is a paid position.
PRIMARY JOB RESPONSIBILITIES
DEPARTMENTAL AND ADDITIONAL JOB RESPONSIBILITIES
1. The CRI may also be involved in other regulatory duties, budgeting duties, and assisting with reconciliation of study invoices.
2. Other duties as assigned
JOB SPECIFICATIONS
EDUCATION
EXPERIENCE
ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS
These physical requirements are not exhaustive and additional job related physical requirements may be added on an as needed basis. Corrective devices may be used to meet physical requirements.
ESSENTIAL TECHNICAL ABILITIES
ESSENTIAL MENTAL ABILITIES
ESSENTIAL SENSORY REQUIREMENTS
INTERPERSONAL SKILLS
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