POSITION DESCRIPTION:
The Clinical Research Specialisy (CRS) works under the supervision of the study
manager to satisfy applicable clinical and regulatory requirements and Medtronic internal
requirements for the initiation, management, monitoring and closing of clinical studies.
POSITION RESPONSIBILITIES:
Follow all work/quality procedures to ensure quality system compliance and high
quality work.
Under the direction of the study manager, the CRS will assist with review and writing
of clinical plans, study work instructions and guidelines, as well as performing
activities and generating reports for one or more significant subparts of the study
(e.g., monitoring, data management, adverse events, deaths, protocol deviations,
legal agreements, study training, patient informed consents)
Assists in the development of the Clinical Investigational Plan, Clinical Management
Plan, Data Management Plan, study training materials, and study reports in
consultation with the study manager, clinical team, and investigators.
Assists with site identification, qualification, initiation, training, monitoring, and close
out activities to ensure study compliance and subject protection.
Responsible for limited site monitoring (review source documentation, case report
forms, and data reports for accuracy and ensure the timely submission of such
documentation) to assure compliance with the Investigational Plan, Monitoring Plan,
applicable regulatory, IRB, and Medtronic standards, guidelines and policies.
Prepare accurate and timely monitoring reports and follow action items through
resolution.
Ensure accurate inventory accountability of investigative product at assigned clinical
sites.
May participate in process improvement initiatives.
Assists in ensuring site activities in line with milestones (i.e. startup, recruitment,
closeout, etc) and implement contingency plans as needed
Responsible for accurate and timely adverse event reporting during the study.
Ensure site adherence to MoH, FDA, Regulatory, IRB and Medtronic requirements.
Work with investigators to quickly and effectively resolve problems.
BASIC QUALIFICATIONS:
Bachelor’s degree
Health related degree
DESIRED/PREFERRED QUALIFICATIONS:
At least 1 years experience supporting clinical research. Clinical research
includes: industry sponsored clinical research, physician sponsored clinical
research, government sponsored clinical research or any other clinical research
that would lead toward regulatory submission, review and approval for market
clearance. Similar medical/scientific experience (e.g. has written and
implemented protocols for experiments or animal research, has a good
understanding of the research process) may be acceptable.
Proficient knowledge of medical terminology
Ability to incorporate and adhere to good clinical practices and regulatory
standards
Self-motivated
High attention to detail and accuracy
Ability to identify and implement solutions in addressing study issues
Ability to cultivate relationships with customers and co-workers in a cross-
functional environment
Capable of clearly and effectively communicating verbally and in writing
Ability to adapt to shifting priorities and competing demands
Ability to maintain composure in difficult circumstances
Ability to identify and overcome obstacles
Experience with Microsoft Word, Excel, PowerPoint; and familiarity with web-
based applications
Bilingual- English and Spanish
Able to work across regions and have a global mindset
El contenido de este aviso es de propiedad del anunciante. Los requisitos de la posición son definidos y administrados por el anunciante sin que Bumeran sea responsable por ello.
Ciudad: capital federal
