In House CRA
Clinical Affiars | Durham, NC
Are you an experineced In House CRA that is stuck in rut? Tired of doing the same thing day after day? Then checkout this great opportunity with Health Decisions. Our In House CRAs play an important role in the conduct of clinical trials.
Health Decisions is the leading clinical research organization (CRO) in Adaptive Clinical Trials, committed to shortening development timelines and maximizing pipeline value for pharmaceutical, biotech and medical device companies. Through Agile Clinical Development — a strategic three-pronged approach that combines adaptive design, adaptive operations and proprietary technology — Health Decisions delivers real-time performance metrics that enable sponsors to make the most of competitive market opportunities.
We are currently seeking an In House CRA to serve as the central point of contact for remote sites and IRB.
The In-House CRA will be responsible for the following:
- Maintains study applications including the study portal and trial management system.
- Reviews essential documents for content through all phases of the study.
- Maintains study central files and site regulatory files.
- Conducts routine TMF audits.
- Performs in-house data cleaning.
- Writes and resolves queries.
- Prepares agendas and meeting minutes
- Review and preparation of IRB submission materials
- Handling of SAEs
- Writing SAE narratives
- Negotiation of contracts and budgets
- Investigator payments
- Management of subject closeout
- Site feasibility and investigator selection
- Organization of Investigator Meetings as applicable
- Internal and external audit responses and reconciliation
- Development of study documents
- Status reporting as needed
- BA/BS degree (preferably in a life science), nursing qualification or relevant experience.
- Proficient computer skills, especially in Microsoft Office. Ability to learn other applications.
- Excellent written, oral communication and presentation skills.
- Read, write and speak fluent English; fluent in host country language.
Health Decisions is an Affirmative Action/Equal Opportunity Employer. All qualified candidates are encouraged to apply.
Health Decisions is an E-Verify employer. E-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Please click on the following links for more information.
E-Verify Participation Poster: For English click here, For Spanish click here
E-Verity Right to Work Poster: For English click here, For Spanish click here