Clinical Research Specialist, Study Start Up - Hybrid/Remote

Please apply online using a laptop or desktop computer.
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 execution in a key clinical program to support the development and advancement of cell and gene therapies. This position can be remote (US) or hybrid. #LI-Remote #LI-Hybrid
Check out our video Saving Lives: It's the Best Job Ever

ACCOUNTABILITIES:
Site Management:

• Oversee and manage operational aspects of clinical trial sites in conjunction with project teams.
• Oversee site activation and ensure Study Start-up and enrollment goals are met.
• Collect and review essential documentation for investigational sites, including maintenance of the electronic Trial Master File and the Clinical Study Management System.
• Serve as primary liaison for site start-up and site management issues 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, Study Coordinators, and other appropriate site personnel regarding study workflow, overcoming obstacles, and general questions regarding study conduct.

Remote and Centralized Monitoring:

• As needed for assigned studies, performs remote monitoring visits. Remote monitoring activities involve limited, risk-based source document verification, review of essential regulatory documents, and site performance.
• Ensure compliance with clinical trial protocols based on regulations, ICH GCP guidelines, and NMDP standard operations procedures.
• Identify and communicate visit findings with site study personnel and the study team.
• Performs query management activities and generates study and site status reports.
• Assists in reviewing study site data and data reports to ensure timely and accurate submission and compliance with the study protocol.
• With oversight and guidance, analyze trends in identified issues, and author visit reports and letters. Ensures documentation and resolution of identified issues and implementation of corrective and preventative action.

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.
• Assist in User Acceptance Testing (UAT) of clinical database management system for individual clinical trials.
• Perform study tracking (e.g., CTMS, start-up, milestone, closeout); generate, review, and distribute management reports from internal tracking systems at requested intervals.
• Assist in preparing and reviewing study materials for Study Start-up, assuring continued validity of such documents, and making necessary
• 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.
• Assist in protocol tracking and communications.
• 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 management processes, guidelines, tools, templates, best practices, and overall implementation.
• Other duties as assigned.

• Clinical research study processes and protocol management.
• Medical terminology and anatomy/physiology.
• Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of internet.
• Training and conflict resolution skills.
• Adverse events and protocol deviations as identified in the protocol or investigator brochure.

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 two 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.
• Prior site experience.
• Experience developing clinical strategies and study design.
• Knowledge of clinical monitoring functions and reporting.
• Experience with CRO teams.

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.

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