Clinical Research Supervisor

Alivation Health, LLC•Lincoln, NE

About The Position

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 Clinical Research Supervisor 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 If you have a perceptive passion to promote research studies in a collaborative team environment, with an innate learning desire that resonates with our core values to deliver and enhance the best patient care, we would like to meet you. Ultimately, you will assume an important role in the promotion of clinical research performing all activities involved in conducting clinical studies in a safe and therapeutic physical environment, specifically the patient visits rating scales and assessments for the research trials. JOB SUMMARY: The primary responsibility of the Clinical Research Supervisor 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 supervision 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. TALENT: Eager, determined to achieve success, and committed to making a difference every day Compassionate and care deeply about our patients and their experience Love what you do and where you work Not afraid to ask questions and grow as a professional Ability to have open, honest conversations with patients and team members Self-motivated Integrity belief in everything you do

Requirements

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
Minimum Three Years Management Experience | Proven Track Record

Nice To Haves

Previous Experience Conducting Clinical Research Studies Preferred | Previous Experience In Psychiatric Treatment Preferred

Responsibilities

Implements and supports the practice mission and strategic vision within respective departments.
Plans and organizes the daily operations of the research team.
Provides technical leadership and administrative supervision to CRCs engaged in the execution of research protocol; participates in staff hiring, provides training, allocates and coordinates work assignments, and evaluates performance of staff.
Develops quality standards and programs; monitors and maintains quality of unit performance in accordance with internal policies and standards and grant and/or contract parameters.
Assists in the development of operating goals and objectives for the department; implements and administers methods and procedures to enhance operations, as appropriate to the department.
Assists in 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.
Recruit patients to participate in research studies in person, over the phone, and through community outreach and/or events: This includes explaining the study design, purpose, and requirements, as well as pre-screening for eligibility and answering any questions the patient may have.
Schedules patient visits: This includes coordinating provider schedules and research schedules.
Conducts patient visits while observing all protocol and GCP requirements and guidelines.
Receives and dispenses study medication.
Monitors adverse events and concomitant medications at each visit.
Performs/assists with safety assessments during the patient visits, including height, weight, blood pressure, temperature, respiratory, ECG, blood draw and urine collection.
Completes all data entry required after each visit: This includes answering sponsor queries.
Able to organize and submit all required documents for each specific study to the sponsor, IRB, study team, and any other applicable parties.
Assists with maintaining and organizing regulatory documents for research trials.
Maintains patient and regulatory master files to assure audit readiness.
Attend 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.
Other clinical or administrative duties as assigned to meet practice needs.