Clinical Research Site Mgr. jobs in United States
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Numinus · 5 months ago

Clinical Research Site Mgr.

Numinus is seeking a detail-oriented and experienced Clinical Research Site Manager to oversee the daily operations of clinical trials at their Clinical Research Mental Health Sites. The role involves coordinating and supervising the activities of the clinical research coordinator team, ensuring compliance with protocols, and managing overall clinical objectives.

Alternative MedicineHealth CareTherapeuticsWellness

Responsibilities

Ensuring that the clinical trials are conducted in accordance with ethical principles and within regulatory requirements
Collaborate with Principle Investigator, Director of Research Operations, Regulatory and Recruitment teams to ensure the smooth running of clinical trials
Supervising the collection, storage and processing of data to maintain integrity and accuracy
In conjunction with Regulatory and Clinical Trial Project Mgr., coordinate and oversee clinical studies from initiation to closeout
With Leadership, Regulatory and Project Mgr. teams, ensure all clinical studies are conducted in accordance with regulatory requirements and study protocols
Manage resources, timelines, and quality of clinical research coordinators
Training and mentoring clinical research coordinators
Oversees administrative duties related to study CRC personnel including orientation, assuring core competencies, basic certifications, safety/responsible conduct of research education; conducts performance reviews
Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed
Oversee data management and analysis, and ensure data integrity (EDC-Source) and query resolution
Other Site Management Duties as assigned

Qualification

Clinical Research ManagementClinical Practice (GCP)FDA RegulationsClinical Data ManagementCertified Clinical Research Coordinator (CCRC)Team CoordinationLeadership SkillsCommunication SkillsProblem-Solving Skills

Required

Proven work experience as a Clinical Research Site Manager
5-7 Years Clinical Research Experience as a CRC with a focus on managing clinical trials
Deep knowledge of Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements
Experience in clinical trials and knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
Familiarity with clinical data management systems and procedures
Strong leadership, project management, and team coordination skills
Excellent analytical, decision-making, and problem-solving skills
Experience performing clinical assessments, including but not limited to obtaining vital signs EKGs, blood draws, processing/shipping lab specimens

Preferred

Certified Clinical Research Coordinator (CCRC) certification

Company

Numinus

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Numinus utilizes psychedelic-assisted psychotherapy methods to bring holistic healthcare to patients.

Funding

Current Stage
Public Company
Total Funding
$65.52M
2024-02-01Post Ipo Equity· $4.48M
2021-03-19Post Ipo Equity· $40.25M
2020-12-29Post Ipo Equity· $17.3M

Leadership Team

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Gina Ratcliff Knutson
People & Culture Business Partner
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Company data provided by crunchbase