Clinical Research Nurse
Part-time or full-time position (remote or local) available for RN with knowledge of electronic medical record systems. Responsibilities include reviewing medical records to determine patient eligibility, abstracts medical record data related to disease and treatment; records medical record data on paper or electronic case report forms. RN or equivalent training and clinical experience, or equivalent training and knowledge of clinical practice. Oncology experience preferred. Send resume via email [email protected]
Clinical Trial Specialist
Full-time position is available for Clinical Trial Specialist (CTS). The CTS will be responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. The CTS provides ongoing site management to ensure project completion within designated timelines. Applicant must have exceptional communication skills in both verbal and written form. Candidates must also be proficient with Microsoft Office products.
Healthcare related Associates degree or equivalent from two-year College or technical school and 2-3 years of healthcare experience required with one year of clinical research experience preferred or an equivalent combination of education and experience. Demonstrated experience with regulatory documentation/compliance in clinical research a plus. Send resume via email [email protected]
Senior/Lead CRA
Full-time home based position available for Senior/Lead Clinical Research Associate (CRA). The Clinical Research Associate will be responsible for monitoring activities in compliance with FDA regulations, ICH/GCP guidelines, Axon Clinical Research SOPs, and sponsor SOPs. The CRA will manage the activities of the clinical investigative sites to ensure successful execution of the protocol. The CRA will also ensure that trial data are accurate, complete, and verifiable from source documents.
We're looking for experienced CRA candidates with diverse monitoring background who can contribute to the project team through monitoring skills and also be willing and able to perform additional project supporting functions such as monitoring report template/annotation prep, review of project plans, co-monitoring, site feasibility/selection activities, presentation at investigator meetings or bid defense meeting or other project activities as needed.
Bachelor's degree in a science or related field and five to seven years related experience. Relevant work experience should include at least five (5) years of Monitoring experience of which at least four (4) to five (5) of those in oncology. Phase I monitoring experience required. Must have a good understanding of the clinical development process and associated regulations. CCRP preferred. Send resume via email [email protected]
Other Skills & Abilities
- CRO experience
- Experience as Monitor
- Experience conducting all visit types (pre-study, Initiation, Monitor Visits, and Close-out visits)
- Oncology
- Early Phase I/II experience (preferably in oncology trials)
- Travel up to 75% (at least 3 days a week)
Project Manager
Full-time home based position available for Project Manager. The Project Manager is responsible for overseeing and coordinating all study management activities, study teams, and project timelines for Axon Clinical Research. The Project Manager works closely with the funder, sponsor, investigator, and appropriate staff in each department of Axon Clinical Research including medical writer, data management, regulatory, quality assurance, contracts, and scientists as need to launch and complete the study. The Project Manager will manage the trials at the sites and have responsibility for timelines and budget adherence with each trial.
Bachelor's degree (in life science preferred) with 5 years' experience as a Clinical Trial/Research Project Manager of which at least three (3) years in Early Phase Oncology. MS degree preferred. Must have CRO and oncology trial experience. Global clinical trial management experience preferred. Ability to perform all tasks required of Sr. CRA, experience in clinical trials monitoring.Send resume via email [email protected]
Other Skills & Abilities
- MS Project/Gantt chart experience
- Excellent Presentation/Bid Defense skills
- Budget Planning/Forecasting skills
- Early/Late Phase Trial Management preferred
- Excellent organizational skills
- Demonstrated ability to lead and manage teams
- Excellent interpersonal skills
- Excellent oral and written communication skills
Clinical Research Associate (CRA)
Full-time position available for Clinical Research Associate (CRA). The Clinical Research Associate will be responsible for monitoring activities in compliance with FDA regulations, ICH/GCP guidelines, Axon Clinical Research SOPs, and sponsor SOPs. The CRA will manage the activities of the clinical investigative sites to ensure successful execution of the protocol. The CRA will also ensure that trial data are accurate, complete, and verifiable from source documents.
Bachelor's degree in life sciences or research related field and two years related experience. Must have at least 2 years clinical research experience with a good understanding of the clinical development process and associated regulations. CCRP preferred. Relevant work experience should include at least one (1) year of Monitoring experience. Send resume via email [email protected]
Other Skills & Abilities
- CRO experience
- Experience as Monitor
- Experience conducting all visit types (pre-study, Initiation, Monitor Visits, and Close-out visits)
- Oncology
- Early Phase I experience (preferably in oncology trials)
- Travel up to 75% (at least 3 days a week)
