Clinical Research Operations Specialist jobs in United States
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N-Power Medicine, Inc. · 22 hours ago

Clinical Research Operations Specialist

N-Power Medicine, Inc. aims to transform clinical trials through better integration with clinical practice. They are seeking an experienced Clinical Research Operations Specialist to oversee the planning, implementation, and management of oncology clinical trials, ensuring streamlined communication and executional excellence across multiple trial sites.

BiotechnologyClinical TrialsPharmaceutical
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Hiring Manager
Leslie Hess
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Responsibilities

Oversee the end-to-end implementation and execution of assigned oncology studies across multiple Network sites, ensuring compliance with study protocols, timelines, and regulatory requirements
Act as a strategic liaison between pharma sponsors, contract research organizations (CROs), clinical sites, and internal teams to ensure alignment and execution of study objectives
Proactively identify operational risks and implement creative, timely solutions (SOPs, tools, and best practices) to optimize clinical trial workflow, patient recruitment, and data quality
Collaborate with regulatory, data, quality, and site teams to ensure compliance with applicable regulations and internal SOPs
Monitor trial progress, identify bottlenecks, and proactively address identified operational challenges
Review and provide input on essential study documents (e.g., protocols, informed consents, site training materials)
Oversee trial-specific training for internal stakeholders and site teams
Responsible for operational input and oversight in designing, planning, initiating and completing clinical trials across assigned disease teams
Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution
Participate in initiatives to establish best practices for optimizing patient enrollment in clinical trials
Collaborate with stakeholders to develop and implement trial specific training programs
Innovate and implement novel patient enrollment strategies to maximize clinical trial participation
Identify and integrate new tools, workflows, and methodologies to improve protocol implementation and patient enrollment processes
Perform additional duties and responsibilities as required
Ensure all trial activities comply with Good Clinical Practice (GCP), Institutional Review Board (IRB) guidelines, FDA regulations, and health system policies
Work closely with other N-Power teams to support submissions, audits, and inspections
Track key performance indicators (KPIs) related to trial enrollment, retention, protocol adherence, and data integrity
Provide regular updates and reports to senior leadership, sponsors, and other key stakeholders
Utilize data-driven insights to recommend operational improvements and enhance trial efficiency

Qualification

Clinical trial managementOncology clinical trial experienceRegulatory complianceStakeholder engagementProject managementInterpersonal skillsOrganizational skillsProblem solvingTeam leadershipCommunication skills

Required

5+ years in clinical trial operations, with experience in a health system setting preferred
Bachelor's degree in life sciences, healthcare administration, or a related field required
Strong understanding of clinical research protocols, regulatory requirements, and site management best practices
Exceptional project management and organizational skills
Strong interpersonal and relationship-building abilities
Ability to manage multiple priorities in a fast-paced environment
Proven ability to navigate highly matrixed environments, managing multiple stakeholders and priorities
Strong track record of successfully executing projects under tight timelines
Exceptional interpersonal and communication skills, with the ability to engage and influence senior stakeholders, clinical teams, and technical experts
Demonstrated ability to inspire teams, foster collaboration, and drive meaningful impact in clinical research
Generous, Curious and Humble

Preferred

Master's degree (MPH, MBA, MS) or clinical background (RN, PharmD) preferred
2+ years in oncology clinical trial experience preferred
Prior experience in management or leading cross functional teams is desirable

Benefits

Equity at hire
Discretionary annual bonus
Company benefits
Competitive industry benefits
401K plan
Other great company “perks”

Company

N-Power Medicine, Inc.

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N-Power Medicine is developing a radically faster, smarter paradigm for drug development that enables biopharma to move beyond traditional randomized clinical trials.

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
Merck Global Health Innovation Fund
2024-05-21Series B

Leadership Team

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Mark Lee
CEO & Co-Founder
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Company data provided by crunchbase