What are the responsibilities and job description for the Clinical Research Coordinator position at AllerVie Health?
Clinical Research Coordinator, Full-time, Homewood, AL
At AllerVie Health, our team members are unified around our mission to help patients achieve and maintain optimal health and quality of life - free from the symptoms and suffering of allergies, asthma, and related immunological conditions. From our physician and clinical roles to our administrative and operational support roles and everything in between - we change lives for the better - giving people their lives, health, and vitality back in real, tangible ways. We live every day on mission and wake up excited to tackle new challenges and provide people with health solutions.
Job Summary:
The Clinical Research Coordinator's duties are to facilitate the successful conduct of clinical trials and provide support to the Principal Investigator and Sub-Investigators. To serve as the liaison between the Principal Investigator, the patients, the Sponsor Monitors (CRO (Contract Research Organization), or pharmaceutical company), and AllerVie Clinical Research.
Duties/Responsibilities:
Job Summary:
The Clinical Research Coordinator's duties are to facilitate the successful conduct of clinical trials and provide support to the Principal Investigator and Sub-Investigators. To serve as the liaison between the Principal Investigator, the patients, the Sponsor Monitors (CRO (Contract Research Organization), or pharmaceutical company), and AllerVie Clinical Research.
Duties/Responsibilities:
- Organization and conduct of clinical study using good clinical practices (GCPs)
- Attend study investigator meetings for assigned studies
- Recruit and consent appropriate patients into assigned studies
- Ensure protocol adherence and accuracy of research data and transcription into data capture systems where appropriate
- Monitor patient compliance and proactively address patient conflicts and report such conflicts to management where appropriate
- Meet chart review, screening, and enrollment quotas within defined timelines
- Ability to work as a team (collaboration with internal and external departments required)
- Complete data entry (eSource) on time and according to ALCOA-C principles to ensure rapid data entry
- Update technology systems on time
- Ensure adequacy of study supplies (lab kits, investigational products, medical supplies, study supplies, ePRO devices, etc)
- Always ensure data availability for sponsor review
- Preparation/completion of interim monitoring visits
- Queries to be addressed appropriately within defined timelines per study protocol
- Completion of findings reported during monitoring visits in a reasonable manner
- Follow-up on specific issues and challenges related to the study. Report such issues to management well in advance
- See to the warehousing of data/study documents during study closure
- Proactively look for ways to assist the clinical team with administrative work
- Perform other job-related duties as assigned
Qualifications, Education and Experience:
- Associate Degree in Nursing, Diploma RN (Research Nurse), Associate Degree in a Life Science, BSN, or BS in a Life Science, OR equivalent experience in clinical research setting without a degree
- 2 years of clinical research experience i.e., clinical research coordinator; OR LVN (Licensed Practical Nurse)
- Proficiency in drug accountability and drug transport
- Proficiency with capturing ECGs and reporting relevant findings to the clinician on staff based upon available interpretation
- Proficiency with collecting vital signs and reporting irregularities to the clinician on staff
- Proficiency with laboratory collection (phlebotomy) along with processing according to available laboratory manuals. Reporting of deviations to management where appropriate
- Proficiency with basic regulatory filing and IRB (INSTITUTIONAL REVIEW BOARD) communication
- Reliable transportation is necessary
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
Travel required: Investigator meetings for study conduct, industry workshops, and associations, ACRP (Association of Clinical Research Professionals), SCRS (Society for Clinical Research Sites) meetings as required for professional development
When you join AllerVie, you join a crucial workforce that provides meaningful care and service to our allergy patients. We value the knowledge and experience you bring to AllerVie and we reward your efforts and dedication with a competitive compensation and benefits offering that allow you to offer your best to our patients.
We Offer:
We Offer:
- Medical, Dental and Vision Insurance Plans
- Employer HSA contribution
- Employer-paid Life Insurance
- Supplemental benefit offerings
- 401(k) Plan with employer match
- Generous PTO and paid holidays
Learn About Us:
LinkedIn - https://www.linkedin.com/company/allervie-health/posts/?feedView=all
Instagram: https://www.instagram.com/allerviehealth/
AllerVie Health is an Equal Opportunity Employer providing equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, national origin, protected veteran status, disability status, or any other legally protected basis, in accordance with applicable law.
LinkedIn - https://www.linkedin.com/company/allervie-health/posts/?feedView=all
Instagram: https://www.instagram.com/allerviehealth/
AllerVie Health is an Equal Opportunity Employer providing equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, national origin, protected veteran status, disability status, or any other legally protected basis, in accordance with applicable law.