Clinical Research Associate 3

This is a fully remote position, open to applicants in Germany.

📋 Description

• Assist in the execution of both pre-market and post-market clinical studies while adhering to regulatory standards.

• Play a key role in clinical research initiatives and ensure effective management of clinical trials.

• Oversee and maintain clinical study data, including investigator qualifications, patient recruitment analysis, and monitoring study progress.

• Manage the initiation and activation of study sites, which involves handling study documents, IRB/EC submissions, regulatory paperwork, clinical trial agreements, budgets, and monitoring plans.

• Modify clinical study documents and provide assistance to clinical sites with submissions to institutional review boards.

• Conduct both on-site and remote qualifications, initiation, interim monitoring, and closure visits for sites.

• Execute clinical study monitoring to ensure compliance with regulatory guidelines and protocols, as well as data integrity.

• Perform source data verification within EDC systems or case report forms.

• Communicate with clinical trial sites regarding data entry, query resolution, investigational device tracking, accountability, and overall study management.

• Collaborate with data management teams for data cleaning processes.

• Assess safety events and assist in the preparation of safety narratives and reports.

• Create and maintain the trial master file, study documentation, clinical trial management system, trip reports, site contacts, and monthly status updates.

• Monitor and manage site payments while supporting financial tracking of the study.

• Aid the Clinical Study Manager with study scoping, design, pre-study questionnaires, and selection of surgeons/sites.

• Support site audits and prepare for inspections.

• Work together with clinical study managers, CTAs, data management personnel, biostatisticians, clinical sites, physicians, nurses, and surgeons.

• Review and analyze clinical literature and contribute to the drafting of clinical study reports and academic publications.

⛳️ Requirements

• Proven experience in the implementation, assistance, and management of medical device trials.

• In-depth knowledge of clinical and/or outcomes research study design.

• Advanced understanding of ISO 14155, 21 CFR Parts 11, 50, 54, and 812, among other relevant regulations.

• Familiarity with ICH/GCP guidelines and clinical research and monitoring obligations.

• Clinical research/clinical trial management certification or relevant education preferred.

• Prior experience in a clinical setting is preferred.

• Experience in negotiating clinical research contracts and budgets.

• Strong ability to work efficiently in cross-functional teams.

• Capability to manage multiple projects and adapt to changing priorities.

• Proficient in Microsoft Office Suite and PDF applications.

• Required experience with electronic data capture (EDC) systems.

• Preferred experience with clinical trial management systems.

• Required background in the medical device industry.

• Experience conducting clinical trials focused on COPD is required.

• A minimum of 6 years of relevant experience with a BA/BS degree; or at least 4 years of experience along with a Nursing degree, Master's degree, or MD/PhD with a minimum of 1 year of experience; or equivalent experience in a scientific domain.

• Hospital experience and familiarity with working alongside nurses and surgeons is preferred.

• Strong knowledge of statistics, statistical methods, and experimental design is highly desirable.

• Current proof of vaccination against certain diseases may be a requirement.

• Preference will be given to qualified candidates who do not currently reside or plan to reside in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

🏝️ Benefits

• Competitive base salary, incentives, benefits, and equity options.

• Possible vaccination requirements, including COVID-19 vaccination.

• Equal employment opportunity and protections against discrimination.