Senior Clinical Research Associate - Rare Disease - East Coast
- Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies
- Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded
- Conduct study initiation visits (SIVs)
- While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements
- Excellent interpersonal, oral, and written communication skills in English
- Superior organizational skills with attention to details
- Ability to work with little or no supervision
- Proficiency in Microsoft Office, CTMS and EDC Systems
- 5+ years of experience as a Clinical Research Associate
- 4-year universitydegree or RN/BSN in Nursing
- Experience in Rare Disease required
- Candidates must reside in the Eastern United States
- Willingness to travel required
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