Aventiv Research is currently looking for a Registered Nurse (must be registered in Ohio) with a passion for clinical research to join our Phase I unit as a Clinical Research Coordinator (CRC). Experience in clinical research is a plus. As a CRC, you will be responsible for understanding and implementing clinical research studies under the direction of the Principal Investigator. Other responsibilities include:
Assist administration/investigators with study feasibility and selection of studies.
Act as a liaison between the research staff and the sponsors, drug companies, IRB, federal, and state officials and other regulatory agencies.
Schedule, prepare, and conduct monitor visits and sponsor/Federal Drug Administration audits.
Attend investigator’s meetings and site initiation visits with the sponsor to review and assess progress and conduct the study.
Coordinate protocol specific training for study staff and communicate important study updates such as study start-up and protocol amendments with all appropriate staff.
Meet or exceed enrollment goals and modify recruitment strategies as necessary; recruit and screen patients for specific studies.
Execute Informed Consent Forms according to ICH and GCP guidelines.
Perform assessments at study visits according to protocol. Document study visits in source according to ALCOA-CCC.
Collect, process, and ship laboratory samples according to protocol.
Enter source document data into respective EDC vendor system and respond to queries in a timely manner
Perform vitals, ECG, and other study assessments required by protocol.
Record adverse events and serious adverse events per sponsor guidance. Maintain timely follow-up to determine resolution of adverse event.
Monitor investigational product temperature logs and report temperature excursions.
Document protocol deviations and report to the IRB if applicable.
Maintain regulatory documents from study start up to study completion.
The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to sit or stand for long periods of time, use hands and fingers in fine manipulation of office and medical equipment, use the telephone, talk and hear. The employee will reach, stand, stoop, kneel, crouch and lift up to 15 pounds.
Aventiv’s Culture is defined by its Core Values:
Dedication – We are dedicated to our company, patients and co-workers. We all strive for the same goal and we do what we need to do to achieve it, all while offering unending support to our coworkers and patients.
Integrity – We do the right thing when no one is watching. All Aventiv employees have strong moral principles.
Resourcefulness – Aventiv employees have versatile skill sets. By doing what we are good at, as individuals and as a team, we are able to find clever ways to overcome boundaries and obstacles.
Professionalism – Every Aventiv employee is held to the highest behavioral, ethical, and social standard. We achieve excellence by conducting our work with professional competence and expertise.
Hours are generally Mon – Thurs, 7am – 5pm, with an alternating Friday schedule. The first Friday, 8am – 12pm, and then closed the following Friday. The Phase I unit will require evening and overnight hours as specified by the trial. Employees are provided ample notice of schedule adjustments.
Aventiv offers a competitive and comprehensive benefit package.
To be considered for the position, you must meet the following qualifications:
Self-directed and able to work without supervision
Excellent written and verbal communication skills
Ability to multitask, prioritize, and manage time efficiently
Ability to work in a team setting as well as independently
Enjoy interacting with a diverse group of people with an ability to listen and provide empathy when needed
Additional Salary Information: Bonus for Overnights
Internal Number: 101
About Aventiv Research Inc
Aventiv Research is an independent, multi-therapeutic outpatient clinical research center performing clinical trials since 2007. Our mission is to enrich the lives of both our team members and patients by putting medical research to work. Our team is dedicated to making the world a better place by providing people access to innovative healthcare and data and clarify and inspire better medicine. We are attentive, diligently committed in every detail as we deliver consistently high-quality data to our sponsors.
Built on the core values of dedication, integrity, resourcefulness, and professionalism, Aventiv Research embraces a visionary, entrepreneurial spirit that compels our ambassadors to blaze new trails with proprietary systems and processes.