Research Associates - Nationwide
Clinical Research International is
a full-service contract research organization with international
resources dedicated to helping pharmaceutical and biotechnology
companies, efficiently and expeditiously navigate the
regulatory approval process in order to bring new drugs and
biologics to the people who need them.
Duties and responsibilities:
with coordinating and performing all aspects of the clinical
monitoring process in accordance with GCPs and SOPs.
site visits to verify that: the rights and well-being of human
subjects are protected; the reported trial data are complete,
accurate, and verifiable per source documents; and that the
trial is conducted in compliance with the currently approved
protocol, Good Clinical Practices (GCPs), and Standard Operating
responsibilities include verifying proper storage conditions,
accountability, and disposition of the investigational products
and maintenance of up-to-date and accurate investigator study
files. Submits written reports of investigational site findings.
May be involved in organizing or participating in investigator's
meetings, study report writing, and the development of
protocols, case report forms and study procedures manuals.
with multidisciplinary project teams in preparing and
implementing clinical development plans and provides clinical
research expertise in support of other departments.
with identifying and evaluating qualified investigators,
investigational sites, and CROs to perform studies and provide
clinical consultations via site visits, site profiles,
historical performance and interactions with internal and
with monitoring and/or supervising the monitoring activities
performed by contract research organizations (CRO); serve as a
trainer and resource for contract research organizations (CROs).
with establishing policies and ensuring adherence to applicable
regulatory and clinical standards by participating in the
creation, review, and approval of departmental operating
and maintain expertise in regulations for all geographies and
types of studies. Serve as a resource related to clinical trial
knowledge related to projects and therapeutic areas to better
interact with investigators and external study coordinators.
Bachelor's degree in biology, medical technology (registered
nurses also required).
6 months of related work experience.
of GCP, ICH and FDA Regulations.
oral and written communication skills.
degree of professionalism.
to work both independently and in a team environment.
report writing (e.g., monitoring reports, letters to sites).