Job Details
Job Title: Clinical Research Specialist
Job ID: 14427
Location: Virtual, Minnesota 55448
Duration: 24 Months
Job Description:
HM's Top 3:
Site Management experience (site or sponsor)
Knowledge of/experience with CTMS/EDC/TMF
Experience with Good Clinical Practice (GCP)
Education Required: Bachelor s degree (prefer degree in engineering, life sciences, or related medical/scientific field.)
Years Experience Required: Minimum 2 years with bachelor s degree and 0 years experience with advanced degree.
Will the contractor be working 40 hours a week? 40 hours per week
Will the contingent worker be working remotely or onsite, or both? Remote
In this exciting role as a Clinical Research Specialist, you will have primary focus responsibility in preparing sites for data collection, relationship building with research coordinators, regulatory report writing, and data cleaning. The CRS works under the direction of a Clinical Study Manager and assists with numerous tasks associated with the execution of a clinical trial.
The Study & Scientific Solutions (S&SS) is a function within Client Core Clinical Solutions (MC2). S&SS is an internal service provider to all of Client and assigns resources to assist Business Units execute on clinical trials and scientific projects when they have an increase in workload.
Responsibilities may include the following and other duties may be assigned:
Oversees, designs, plans, and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms.
Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer commercial potential.
Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
May be responsible for clinical supply operations, site, and vendor selection.
Specialist Career Stream: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
Differentiating Factors Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
Innovation And Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication And Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contact others to share information, status, needs and issues to inform, gain input, and support decision making.
Leadership And Talent Management: May provide guidance and assistance to entry level professionals and / or employees in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Thank You
Devyansh Sharma
Associate Recruite