Sr. Clinical Research Associate, CRO Services

e 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.

Responsibilities
• Monitoring:
•\tIndependently performs full-scope remote and on-site monitoring visits
involving source document verification, review of essential regulatory
documents, and assessing site performance.
• Ensure compliance with clinical trial protocols based on regulations, ICH
GCP guidelines, and NMDP standard operating procedures.
• Identify, manage, and communicate site findings with site study personnel
and the study team.
• Perform query management activities and generate study and site status
reports.
• Independently 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.
• Serve as Lead CRA on studies with multiple assigned CRAs, including
developing and monitoring of study metrics, overseeing clinical monitoring plan
compliance and escalating study risks, with minimal supervision.
• Site Management:
•\tOversee and manage operational aspects of clinical trial sites in
conjunction with project teams.
• Assists with site activation and ensures study start-up and enrollment
goals are met.
• Collect and review essential documents for investigational sites, including
maintenance of electronic Trial Master File.
• Serves as primary liaison for site management issues for assigned studies,
escalating to the clinical project manager as required.
• Utilizes 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
staff personnel regarding study workflow, overcoming obstacles, and general
questions regarding study conduct.
• Demonstrates the ability to train site staff on complex data reporting, and
protocol and regulatory compliance.
• Centralized Monitoring:
•\tLeads and trains others in reviewing study site data and data reports to
ensure timely and accurate submission and compliance with the study protocol.
• Develops, improves and maintains study-specific processes and workflows for
centralized data review.
• Other duties as required for clinical operations:
•\tPerforms 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 and train other CRAs in user acceptance testing (UAT) of clinical
database management system for individual clinical trials.
• Performs and oversees study tracking (e.g., CTMS, start-up, milestone,
closeout); generates, reviews, and distributes management reports from internal
tracking systems proactively and at requested intervals.
• Develops, maintains, and presents clinical trial and project specific
training materials.
• Leads study related problem-solving activities internally and at trial
sites.
• Assists in protocol maintenance, tracking, and communications.
• May participate in the development of study protocols and case report
forms. Participates in and may lead development of clinical monitoring plan and
provides expert input.
• Authors and reviews drafts of study-specific CRF completion guidelines.
• Works with internal and external team members to deliver high quality trial
execution.
• Participates in shared team responsibilities, ensuring optimal coverage of
trials.
• Participates in and may lead 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.
• Participates in training junior CRAs on moderately complex concepts,
processes, and tasks. May perform Quality or Performance Assessment Visits of
CRA I, CRA II, or other Sr. CRAs.
• Other duties as assigned.

Requirements
• Knowledge of:
• Advanced understanding of clinical research study processes, study design
and/or protocol management.
• Advanced knowledge of clinical trial monitoring procedures and clinical
data reporting processes
• Strong knowledge base of medical terminology and anatomy/physiology.
• Computer proficiency, including the use of standard software (word
processing, databases, email) and use of internet.
• Advanced project management, training, and conflict resolution skills.
• Strong time management skills and problem-solving abilities
• Ability to:
• Demonstrated leadership skills, fostering collaboration and motivating team
members.
• Manage multiple deadlines and priorities independently while ensuring
quality and timeliness.
• Performs tasks requiring excellent attention to detail.
• Demonstrate independent problem-solving and decision-making, including in
complex situations.
• Proactively analyze trends, identify issues and escalate as appropriate.
• Adapt to change.
• Lead processes and people involved in clinical research, demonstrating
organizational awareness and interpersonal skills necessary to complete work
efficiently.
• Travel 25-50%, both domestic and international, depending on assigned
studies. Travel at times may increase up to 70% as required.
• Mentor junior team members.
• Must exemplify our NMDP values in a highly professional manner in all
settings.
• Education and/or Experience:
• Bachelor’s 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.
• Minimum of five years of experience conducting clinical research studies,
with at least three years’ direct experience monitoring complex clinical
research studies.

Nice-to-haves
• Advanced knowledge of cellular therapies, diseases treated by cellular
therapies, disease assessments, and common treatment complications.
• Direct experience working at research sites on clinical studies, with or
without direct interaction with patients.
• ACRP or SOCRA certification.
• Advanced degree in healthcare/science related field.

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
[https://www.nmdp.org/-/media/project/nmdp/nmdpsite/pdfs/external/candidate-employee-total-rewards-summary.pdf]