Clinical Research Associate
eTeam
- Durham, North Carolina, United States
- Durham, North Carolina, United States
Über
Work directly with patients/subjects and investigator site staff to ensure the collection of high-quality clinical data in compliance with protocol requirements and local regulations. Support study start-up activities, including the collection and submission of regulatory documentation, ethics approvals, and investigational product (IP) release documentation. Attend and participate in investigator meetings, monitoring visits, audits, seminars, and other study-related meetings. Assist with subject screening, enrollment, and retention activities. Support the development and execution of recruitment and contingency plans for assigned studies. Perform protocol-required study procedures, as delegated by the investigator and permitted by local regulations, including:
Vital signs collection Phlebotomy Diagnostic testing Investigational product dispensing Scheduling and coordination of study visits Drug accountability and reconciliation General study coordination activities
Complete source documentation and case report forms (CRFs) accurately in both paper and electronic formats. Assist investigators with the recording and reporting of adverse events in accordance with regulatory requirements. Ensure required data protection agreements and site documentation are maintained and filed appropriately. Maintain compliance with study protocols, SOPs, Good Clinical Practice (GCP), and applicable local regulations.
Required Qualifications
Registered Nurse (RN), Medical Doctor (MD), or equivalent healthcare/life sciences qualification. Minimum of 2 years of clinical monitoring experience as a CRA. Minimum of 1 year of obesity study monitoring experience. Candidates with 2+ years of endocrinology monitoring experience will also be considered. Strong understanding of clinical research processes, GCP, and regulatory requirements. Experience with site management, patient recruitment, and study start-up activities. Excellent interpersonal, organizational, and communication skills. Proficiency with Microsoft Office applications. Ability to work independently, prioritize tasks effectively, and collaborate within a team environment. Strong problem-solving skills and attention to detail. Ability to maintain confidentiality and build effective relationships with investigators, site staff, clients, and internal teams. Fluent in the local language (spoken and written) and proficient in written English.
Preferred Qualifications
Prior contracting or contract research experience. Experience supporting obesity and/or endocrinology clinical trials. Strong site relationship management and study coordination skills.
Location Preference Candidates must be located near major hub cities within one of the following states:
Georgia (GA) Florida (FL) Texas (TX) California (CA)
Sprachkenntnisse
- English
Hinweis für Nutzer
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