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)
Unique opportunity to make an Impact in the healthcare industry…
Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials.
As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us.
We are seeking a full-time Clinical Research Coordinator with a minimum of 1 year of clinical experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us.
Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to:
Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable.
Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents.
Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods.
Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting.
Maintain professional and technical knowledge about Clinical trials.
Research participant/family communication, protect patient confidentiality.
Preferred Qualifications:
Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available.
Phlebotomy skills preferred.
Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification.
Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices.
IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
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