Website CYNET SYSTEMS
CYNET SYSTEMS
Company : CYNET SYSTEMS
Job Description:
Pay Range: $79.93hr – $89.93hr
- The Senior Clinical Research Associate (CRA) will contribute to the start-up, execution, and management of clinical studies from initiation through FDA approval.
- This role involves collaboration with internal teams, clinical sites, and external partners to ensure study compliance, accuracy, and efficiency in accordance with GCP, ICH, and regulatory standards.
Responsibilities:
- Contribute to all clinical research activities to ensure successful study start-up and management through FDA approval.
- Maintain and track clinical study data, monitor site progress, and assist with investigator qualification, training, and patient recruitment.
- Co-manage site start-up and activation, including preparation of study-related documents, checklists, budgets, and clinical trial agreements.
- Support eCRFs/EDC systems, CTMS, eTMF, and imaging core labs.
- Review IRB submissions, consent forms, and regulatory documentation, ensuring timely and successful outcomes.
- Assist in drafting and amending clinical study documents (protocols, ICFs, CRFs, monitoring plans, study tools, etc.).
- Perform or assist in on-site and remote visits including qualification, initiation, interim monitoring, and close-out visits.
- Conduct co-monitoring to ensure regulatory and protocol compliance and verify source data accuracy.
- Support clinical trial sites to maintain data integrity, timely data entry, and proper investigational product accountability.
- Partner with CRO data management teams to facilitate the data cleaning process.
- Develop and manage study documentation, including eTMF, trip reports, correspondence, and monthly status updates.
- Assist the Senior Clinical Project Manager with study scoping, site selection, and design activities.
- Support sites in audit preparation and participate in internal and external audits.
- Assist in preparation and delivery of Site Initiation Visits (SIVs) and Investigator Meetings.
Required Skills and Experience:
- Proven experience implementing pharmaceutical trials; experience with surgical trials preferred.
- Advanced knowledge of clinical investigation processes, investigational drug studies, and ICH/GCP regulations.
- Strong understanding of clinical research and monitoring requirements.
- Experience with protocol and informed consent form (ICF) development and amendments.
- Proficiency in Microsoft Office Suite, PDF tools, and electronic systems (EDC, CTMS, eTMF).
- Excellent communication, presentation, and organizational skills.
- Strong ability to collaborate across functions and work with physicians and external partners.
- Experience negotiating clinical research contracts and budgets.
- Ability to manage multiple priorities and adapt to changing requirements.
- Must be able to travel up to 40%.
Preferred Skills and Experience:
- Knowledge of statistics, statistical methods, and experimental design.
- Experience working in a hospital environment and collaborating with nurses and surgeons.
- Clinical research or clinical trial management certification preferred.
Qualifications:
- Bachelor s degree with a minimum of 8 years of related experience, or
- Nursing degree or Master s degree with at least 6 years of clinical research experience, or
- MD or PhD with a minimum of 5 years of clinical research experience.