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.
To apply, submit your resume to [email protected]