- Title: Clinical Research Associate
- Code: RCI-5793
- Location: North Chicago Illinois (IL) 60064
- Posted Date: 10/14/2020
- Duration: 1 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Study Clinical Research Associate (CRA)
This position may require up to approximately 25% travel.
Prior clinical trial experience with medical devices (IDEs), preferably with cardiovascular focus.
- Individual contributor participating in the execution of clinical studies.
- Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures.
- Able to solve a range of straightforward problems and analyze possible solutions using standard procedures.
- May contribute to developing study related materials.
- Dedicated focus is on study management support activities which may include vendor oversight.
- May also manage subject eligibility committee depending on trial needs.
- Supports Clinical Project Manager in key study execution tasks
- Ensure regulatory and clinical protocol compliance for all assigned clinical projects.
- Develops and owns study-specific materials such as training slides, document templates (i.e. DoA, training logs), and newsletters.
- Assists with development of study-related materials such as: patient brochures, patient recruitment material, and presentations.
- Reviews informed consent document to ensure all required elements are included.
- Assists with site selection processes.
- In partnership with assigned field staff and in-house personnel; coordinates the oversight of clinical trial site management.
- Coordinates activities with study specific committees, vendor services, and core labs.
- As applicable, manage all aspects of subject eligibility committee work including: screening pipeline oversight, presentation preparation, organization of meetings, and tracking of meeting outcomes.
- Reviews documents (e.g. study document templates and site activation regulatory documents) for accuracy and completeness.
- Serves as a liaison to clinical project management and site management personnel related to study activities and questions.
- Provides periodic updates on site and/or study statuses, as requested by the Clinical Project Manager
- Communicates and collaborates with differing levels of internal and external stakeholders.
- As applicable, for eligibility committee management, effectively and confidently interface with Customers/KOLs, Physician Members, National Principal Investigators, Field Clinical, Medical Directors, and Clinical Science, Research and Development, and other internal personnel.
- Applies general clinical research processes and regulatory knowledge to ensure all output is of high quality.
- Have a good understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about devices and therapies.
- May make additional contributions as assigned.
Required: Bachelor degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering with a minimum of 3 years clinical research experience, or an equivalent combination of education and experience.
- Must have strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees.
- Work effectively in a fast paced, dynamic environment and have a strong ability to prioritize with multiple, competing deadlines.
- Work habits include organization, coordination of many tasks, accuracy, and attention to detail. Must be proficient in Microsoft Office Suite and relevant clinical applications.
- Ability to work independently and as needed, have the flexibility for out of hours work.
- Capable of exchanging straightforward information, ask questions, and check for understanding.
- A strong familiarity with clinical trials research processes.
- Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
- Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).