ALIVATION RESEARCH, LLC

Integrated Health Center | Next Level You
Lincoln, NE 68526
A leader in integrated Mental Healthcare for over 20 years with Pharmacy, Primary Care, Aesthetics and Research divisions all in one location, where ideas and opinions are valued and expected, seeks a Manager of Research Operations to join our expanding Research Team, promoting an innovative culture putting the patient’s health and well-being first.
CORE VALUES: Drive | Passion | Humility | Openness | Discipline

JOB SUMMARY:

The primary responsibility of the Manager of Research Operations is to coordinate and quality control the development and maintenance of clinical research studies, ensuring compliance with Human Research Review Committee (IRB) requirements and all related laws, regulations, policies, and guidelines. Provides day-to-day technical leadership and administrative management to a team of research staff engaged in the execution of multiple, complex research protocols. Provides administrative oversight of the research activity and works with the Neuroscience Clinical Research Manager in the formulation and implementation of operating strategies and policies, protocols, systems, and procedures.

• Operations Management: Manage daily operations of Alivation Research site, ensure efficient trial execution and compliance with GCP, OHRP, FDA, and IRB guidelines. Maintain Alivation’s standards meeting the highest quality.
• Team Leadership: Supervise clinical research staff, providing direct and indirect oversight. Oversee hiring, onboarding, resource management, and conduct performance reviews. Lead daily huddles, weekly meetings, and monthly project management meetings as needed. Manages multiple clinical trials (20+).
• Leadership Development: Candidates should expect and embrace self-directed continued leadership development.
• Data Management: Oversee the collection, compilation, and documentation of clinical research data. Review data from patient charts, medical records, interviews, and diagnostic tests. Ensure accurate and reliable data records.
• Fiscal Oversight: Manage departmental and study budgets. Tracks study payments compared to invoices. Ensure financial accountability and efficient resource allocation. Present financial data regularly to the CEO.
• Strategic Planning: Collaborate with leadership to set and accomplish goals, support business development, and identify opportunities for program expansion. Develop and maintain standard operating procedures (SOPs).
• Performance Monitoring: Work with leadership to develop company Objectives and Key Results (OKRs) and develop Key Performance Indicators (KPIs) for Clinical Research Coordinator responsibilities. Execute OKRs and KPIs.
• Technology and Process Management: Oversee Clinical Trial Management Software (CTMS) implementation, maintenance and expansion. Manage non-clinical inventory, procurement, shipping, and temperature logs. Ensure compliance with regulatory and operational protocols.
• Mission & Values: Fully aligned with the mission of Alivation (Company Values | Alivation Research LLC) this includes adapting to high growth. Be ready to excel our team to amazing heights and follow our core values. (Please note, if you are looking to work 40-hour per week, this is not the position for you, only serious applicants please).
• Plan and organize the daily operations of the research team.
• Manages all aspects of study implementation and administration, ensuring compliance with IRB requirements, Federal/State regulations, and grant and/or contract parameters.
• Handles confidential information requiring professional discretion and compliance with protected health information, data integrity and security policies.
• Implements Phase I, II, III and IV pharmaceutical, device, and non-interventional research trials in accordance with GCP guidelines.
• Assists with maintaining and organizing regulatory documents for research trials.
• Maintains patient and regulatory master files to assure audit readiness.
• Attends periodic investigator meetings out-of-state.
• Demonstrates adaptability to changing work demands in terms of priorities that necessitate personal initiative.
• Demonstrates excellent interpersonal skills, strong active listening skills, verbal and written communication skills, patience and trustworthiness to effectively share knowledge with Chief Medical Officer, Neuroscience Clinical Research Manager and patients.
• Others: Do jobs as required including, but not limited to, flexing down to clinical research coordinator job duties, recruitment, study visits, and data entry
  QUALIFICATIONS: Bachelor’s Degree Preferred | Knowledge of FDA Regulations and GCP Guidelines | Proficient Medical Terminology | Basic Life Support (BLS) Certification or In Process | Electronic Data Capture Systems | ECG Machine | Electronic Manometer | Thermometer | Scale | Familiar with EMR & PM Systems | Familiar with Microsoft Platforms
  EXPERIENCE: Minimum Three Years Management Experience | Proven Track Record | Previous Experience Conducting Clinical Research Studies Preferred | Previous Experience in Psychiatric Treatment Preferred | Medical degrees (MD, DO, NP, PA, RN) may be considered in lieu of experience.
  COMPENSATION: Competitively Based.