Role Description
This position supports the CIBMTR CRO Services team by supporting and leading the management of one or more multi-center clinical research studies. This position independently performs site monitoring visits to complete source document verification and assess site compliance. Additionally, this position is responsible for coordinating and providing support for all aspects of the study including protocol and site management, development and management of study metrics, providing training and mentorship to junior team members, and demonstrates advanced knowledge of monitoring functions.
Qualifications
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Advanced understanding of clinical research study processes, study design and/or protocol management.
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Advanced knowledge of clinical trial monitoring procedures and clinical data reporting processes.
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Strong knowledge base of medical terminology and anatomy/physiology.
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Computer proficiency, including the use of standard software (word processing, databases, email) and use of internet.
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Advanced project management, training, and conflict resolution skills.
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Strong time management skills and problem-solving abilities.
Requirements
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Demonstrated leadership skills, fostering collaboration and motivating team members.
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Manage multiple deadlines and priorities independently while ensuring quality and timeliness.
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Performs tasks requiring excellent attention to detail.
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Demonstrate independent problem-solving and decision-making, including in complex situations.
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Proactively analyze trends, identify issues and escalate as appropriate.
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Adapt to change.
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Lead processes and people involved in clinical research, demonstrating organizational awareness and interpersonal skills necessary to complete work efficiently.
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Travel 25-50%, both domestic and international, depending on assigned studies. Travel at times may increase up to 70% as required.
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Mentor junior team members.
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Must exemplify our NMDP values in a highly professional manner in all settings.
Benefits
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Medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits.
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Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees.
Education and/or Experience
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Bachelorβs degree in healthcare/science related field; however, upon evaluation, equivalent related experience and/or education may be substituted for the scientific or health-related degree requirement.
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Minimum of five years of experience conducting clinical research studies, with at least three yearsβ direct experience monitoring complex clinical research studies.
Preferred Qualifications
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Advanced knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
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Direct experience working at research sites on clinical studies, with or without direct interaction with patients.
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ACRP or SOCRA certification.
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Advanced degree in healthcare/science related field.