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)
SPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers, and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking research beyond results to create a marketplace of safer drugs.
Position Snapshot
Job Summary:
Performs a variety of tasks associated with clinical study activities which are integral to the successful conduct of research studies. Handles in-bound and out-bound telephone calls with study site personnel and/or potential study subjects or enrolled subjects. Staff must screen potential subjects via telephone to determine study qualification per study protocol requirements and schedule screening appointments. Staff must perform a variety of duties including study screening check-in, in house stays, OPVs and other study related activity as needed.
Lead Subject Recruiter will perform all of the same duties and responsibilities of Recruitment staff, with a primary focus on study set-up as it relates to recruitment of subjects and telephone screening of these potential study subjects. Additional skills relevant to this position are an ability to exhibit effective time management skills, ensure productivity with minimal supervision, display an ability to work independently and with great attention to detail, as well as a capacity to work appropriately and professionally with the Recruitment team.
Essential Duties and Responsibilities:
The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
Skills/Qualifications
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Hazards:
Education and Experience:
Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.
We are an equal opportunity employer. Spaulding Clinical does not discriminate on the basis of race, religion, sexual orientation, gender identity, age, marital status, national origin, veteran status, disability, or any other basis covered by appropriate law. All aspects of employment are decided on the basis of merit, qualifications, and business need. Simply put, we celebrate diversity in all forms and have zero tolerance for discrimination, harassment, or plain hate.
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