Clinical Research Assessment Coordinator

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 Assessment Coordinator to join our expanding Behavioral Health Research Team promoting an innovative culture, putting the patient’s health and well-being first.

CORE VALUES:
Drive | Passion | Humility | Openness | Discipline

JOB TITLE:

Clinical Research Assessment Coordinator

STATUS:
Regular Full-Time

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.

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

KEY RESPONSIBILITIES:

(Job Description Available Upon Demand)

• Implements and supports the practice mission and strategic vision within respective departments.
• 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.
• Dispenses and receives study medication.
• Monitors adverse events and concomitant medications at each visit.
• Performs rating scales and assessments during the patient visits (especially those in which a MD, PhD, Masters, or equivalent degree is required).
• 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.
• Manages a caseload of various studies and be 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.
• Submits all required documentation to study team, sponsor and IRB.
• 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.

QUALIFICATIONS:

MD (No License Required), PhD, Masters or Equivalent Degree in Mental Health Field Required | 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 |…