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POSITION SUMMARY:
This position supports the CIBMTR CRO Services team by supporting the management of one or more multi-center clinical research studies. This position is responsible for coordinating and providing support for all aspects of study activation in a key clinical program to support the development and advancement of cell and gene therapies. This is a remote position (US). #LI-Remote
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ACCOUNTABILITIES:
Study Activation :
Prepare and review materials (e.g., informed consent form, site document templates) for study start-up, assuring continued validity of such documents, and making necessary updates.
Work in close collaboration with the study teams to ensure study start-up activities and milestones are achieved in a timely and efficient manner.
Proactively identify and address potential study start-up delays, working closely with internal teams and external partners to mitigate risks and meet timelines.
Assist in User Acceptance Testing (UAT) of clinical database management system for individual clinical trials.
Site Activation and Management:
Oversee site activation and ensure site activation goals and milestones are met in conjunction with study teams.
Perform site activation tracking and update CTMS and other systems with data from study sites as per required timelines during the start-up period; generate, review, and distribute management reports from internal tracking systems at requested intervals.
Collect and review essential documentation for investigational sites, including maintenance of the electronic Trial Master File and the Clinical Trial Management System.
Accountable for review of informed consents from site level, coordinates additional review with internal stakeholders; facilitates return of comments/approvals to sites to action.
Serve as primary liaison for site start-up for assigned studies, escalating to the Clinical Project Manager as required.
Utilize effective and proactive communication, relationship building, and issue management to develop and maintain good working relationships with Investigators and site staff.
Provide support to Investigators, site coordinators, and other site personnel regarding study workflow, overcoming obstacles, and general questions regarding study activation and conduct.
Ensure site compliance with clinical trial protocols based on regulations, ICH GCP guidelines, and NMDP standard operations procedures.
Assist, as needed, with study amendments and close-out processes and procedures.
Other duties as required for Clinical Operations:
Perform all duties in compliance with standard operating procedures, regulations outlined in the Code of Federal Regulations (CFR), ICH GCP guidelines, Federal Drug Administration (FDA) guidance, and other applicable Federal, state, and local laws.
Develop, maintain, and present clinical trial and project-specific training materials in conjunction with senior staff.
Assist with study-related problem-solving activities internally and at trial sites.
Collaborate and partner with stakeholders and cross-functional teams to ensure issues or opportunities are communicated, functioning as a reliable, trusted resource of accurate, up-to-date project knowledge.
Participate in shared team responsibilities, ensuring optimal coverage of trials.
Participate in NMDP, CIBMTR, or CIBMTR CRO Services project teams as needed.
Complete and maintain all training requirements.
Develop, maintain, and continuously improve study and site activation and management processes, guidelines, tools, templates, best practices, and overall implementation.
Other duties as assigned.
REQUIRED QUALIFICATIONS:
Knowledge of:
Clinical research study processes and protocol management.
Medical terminology and anatomy/physiology.
ICH GCP guidance and FDA regulations.
Computer proficiency, including the use of standard business and clinical research software (e.g., Microsoft Office Suite, databases, CTMS) and the use of internet.
Training and conflict resolution skills.
Quality assurance.
Ability to:
Demonstrate excellent oral and written communication.
Manage multiple deadlines and priorities while ensuring quality and timeliness.
Perform tasks requiring excellent attention to detail.
Demonstrate independent problem-solving and decision-making for straightforward situations, but requires guidance for complex situations.
Must exemplify NMDP values in a highly professional manner in all settings.
Adapt to change.
Navigate processes and people involved in clinical research, demonstrating organizational awareness and interpersonal skills necessary to complete work efficiently.
Education and/or Experience:
Bachelor's degree in a scientific or health related field; however, upon evaluation, equivalent related experience or education may be substituted for the scientific or health-related degree requirement.
Minimum of three years' experience directly supporting clinical trials. Related advanced degrees may be considered in substitution for clinical trial experience.
PREFERRED QUALIFICATIONS : (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
Knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
ACRP or SOCRA certification.
Experience with CRO teams and developing clinical strategies and study design.
Experience leading study and site activation and reviewing informed consent forms.
DEI COMMITMENT:
As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.
BENEFITS : NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information
