Reports to: Clinical Research Manager
Location: Horizon Oncology & Research Center | Lafayette, IN
Duties and Responsibilities
- Leads site start up activities.
- Develops study specific care plans.
- Provides staff training on new study protocols.
- Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial.
- Maintains continuing communication with the study participants to ensure their understanding of the study protocol, procedures, and requirements.
- Accurately records source documentation in site EMR and study EDC systems.
- Monitors and documents toxicities to treatment.
- Reports Serious Adverse Events to sponsor and IRB as appropriate.
- As necessary, assists with collection, processing, and shipment of specimens.
- Dispenses oral investigational medications per protocol and regulatory guidelines.
- Coordinates required study supplies.
- Resolves queries from study sponsors within required timelines.
- Actively participates in study close out procedures.
- Serves as primary contact for trial specific issues.
- Ensures compliance with federal, state, and organizational guidelines with regard to clinical research protocols.
- Promotes Good Clinical Practices (GCP) in the conduct of clinical trials by possessing an in-depth knowledge of Federal Regulations and Guidance documents for the conduct of clinical trials and human subject protection.
Knowledge, Skills, and Abilities
- Critical thinking skills.
- Ability to track and perform multiple tasks.
- Ability to manage large volumes of information.
- Excellent verbal and written communication skills.
- Must possess a good working knowledge of basic clinical research practice.
- Ability to utilize keen judgment in evaluating information.
- Ability to numerically and accurately enter and calculate test results in an electronic database.
- Ability to work in a stressful environment.
- Must be team oriented.
- Current RN or LPN license in the state of Indiana.
- Previous Experience in Clinical Research preferred.
- Previous Oncology Experience preferred.
- Able to lift 100 pounds to assist fallen patients.
- Able to lift 10 pounds for routine performance of essential functions.
- May be exposed to adverse indoor and outdoor environmental conditions, bloodborne pathogens, physical hazards (e.g., needle pricks, etc.) and chemical hazards.
- May have long periods of sitting and/or standing and walking.
This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.
Come as you are. Here at Verdi Oncology, Inc, we want everyone to feel comfortable being their true, authentic selves at work. This means that we make all employment decisions based on business need, job requirements, and individual qualifications without regard for race, gender, gender identity, sex, color, ethnicity, religion, family or parental status, disability, veteran or military status, or any other statuses protected by Federal laws or regulations or those in the locations where we operate. We are committed to maintaining a workplace that is free of discrimination, harassment, and/or retaliation for all members of the team.
All job requirements are subject to possible revision to reflect changes in the position requirements or to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a threat or risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to which will be required in this position. Employees will be required to follow other job-related duties as requested by their supervisor/manager (within guidelines and compliance with Federal and State Laws). Continued employment remains on an “at-will” basis.
"*" indicates required fields