Clinical Research Site Mgr.

Numinus•Draper, UT

66d

About The Position

Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care. Our clinical research teams are top notch and participate in managing cutting edge clinical trials in the field of mental health. If you are committed to excellence and in the belief of the power of one person making a difference in this world, come join us at Numinus. We are seeking a detail-oriented and experienced Clinical Research Site Manager to oversee the daily operations of clinical trials at two of our Clinical Research Mental Health Sites located in Draper, Utah. In this role, you will be responsible for coordinating and supervising the activities of the clinical research coordinator team, ensuring compliance with protocols, and overall clinical objectives including Site Management for day-to-day operations. The ideal candidate will have a strong background in clinical research and a deep understanding of research methodology, regulations, and procedures in addition to strong experience leading CRC teams.

Requirements

Exceptional leadership and communication skills with experience in clinical research.
Knowledge of business and management principles.
Ability to direct, manage, implement, and evaluate department operations as it relates to CRC team.
Ability to effectively plan, delegate and/or supervise the work of others.
Ability to lead, motivate, develop, and train others.
Strong knowledge of clinical research processes and protocols, including study design, budgeting, and data collection
Strong interpersonal and communication skills to establish productive relationships with research teams, sponsors, and regulatory bodies
Problem-solving skills to effectively deal with issues that may arise during the clinical trial process
Leadership skills and the ability to manage and motivate a team of clinical research coordinators and daily Site operations
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.

Nice To Haves

Certified Clinical Research Coordinator (CCRC) certification preferred.

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