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)
Alliance for Multispecialty Research is a fast-growing clinical research organization that conduct trials for the development of pharmaceuticals.
AMR offers competitive pay, 401K matching, health/dental/vision, paid STD and LTD, as well as on demand access to your pay!
Team Member Benefits:
· Health, Dental, Vision
· Supplemental Life Coverage
· Short-term Disability and Long-term Disability (AMR covers cost)
· Life Insurance (AMR covers cost of AD&D $50,000)
· 401K (employer matching)
· Paid Time Off
· Holiday Pay
· Employee Assistance Program
Clinical Research Coordinator 1 Position Description
Position Overview
The Clinical Research Coordinator I will perform multiple and varied tasks critical to the management of clinical research studies. The Clinical Research Coordinator I is expected to exhibit basic knowledge of clinical research activities and adhere to federal and other applicable regulations. The Clinical Research Coordinator I must ensure compliance with protocol guidelines, identify problems and/or inconsistencies and monitor subject process throughout the clinical research study.
To consistently embody AMR’s Core Values:
· Excellence and Consistency
· Collaborative Innovation
· Respect for our Subjects, Sponsors and Team Members
· Community
· Unimpeachable Ethics
The Clinical Research Coordinator reports to the Clinical Operations Manager.
Classification: Non-Exempt
Primary Responsibilities:
· Coordinate clinical trials per FDA requirements and GCP guidelines per sponsor protocols.
· Basic understanding of SOPs and ensure they are adhered to in the conduct of the clinical research study.
· Basic understanding of medications per clinical trial.
· Acquire detailed knowledge of the protocol and procedures associated with each clinical research study.
· Effectively communicate with clinical research sponsors, CROs, monitors/CRAs, IRBS, laboratories and clinical personnel within the research industry.
· Advise Investigator, Sub-Investigator and staff on protocols, procedures required for the successful implementation and completion of each clinical research study.
· Notify Investigator, monitor/CRA of any adverse events or serious adverse events per the protocol.
· Maintain familiarity with each clinical research study’s requirements and apply all applicable regulations accurately.
· Complete all required documentation in a legible and timely fashion.
· Ensure all necessary documents are appropriately signed and dated.
· Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed.
Desired Skills and Qualifications:
· Successful completion of a formal medical/clinical educational program or in the alternative has a strong knowledge of medical terminology and the ability to learn quickly.
· Clinical experience involving patient care in a healthcare environment preferred but not required.
· Ability to interpret and perform clinical, laboratory and diagnostic tests (such as vital signs, height, weight, temperature, etc.) preferred.
· Ability to function independently with minimal supervision, and to exercise discretion and a high level of good clinical and other professional judgement.
· Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing conditions and deadlines).
· Exceptional written and verbal communication skills.
· Ability to work independently, lead clinical research studies and complete tasks.
· Calm, friendly, approachable, and presents a professional image.
· Excellent listening, written, and verbal communication skills.
· Committed, highly energetic, self- motivated and highly organized.
· Demonstrated proficiency in office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers.
· Proficient in Microsoft Office products including Outlook, Word, and Excel.
· Professional and highly motivated “self-starter” with the ability to exercise initiative.
· Excellent task management and prioritization skills.
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
Job Type: Full-time
Pay: $32.00 - $35.00 per hour
Expected hours: 40 per week
Benefits:
Schedule:
Ability to Relocate:
Work Location: In person
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