Clinical Research Associate II (CRA II) coordinates and supports the clinical teams with oversight of clinical studies. Responsibilities may include such activities as; data management, preparation of study documents, study protocols, case report forms, study progress reports, and clinical site communication.
DESCRIPTION OF RESPONSIBILITIES & AUTHORITIES:
· Supports Project Teams with the management of research studies from study initiation through close-out activities (informed consent development, data and query management, investigational site management, etc.).
· IRB/EC management including site application assistance and approval tracking.
· Responsible for the compilation and maintenance of site regulatory documentation.
· Adheres to good clinical practices, study protocols, and applicable regulations.
· Preparation of study progress reports for project team and sponsor.
· Preparation for safety management review meetings (e.g., binders, agenda preparation, and meeting minutes).
· Performs site qualification, site initiation, interim monitoring (remote and/or on-site) and study close-out activities of study centers for compliance with clinical protocol and applicable regulations.
· Responsible for the maintenance of study specific files and documentation.
· Reviews and manages clinical site payments.
· Authorized to have direct communication with the clinical study sites and conduct daily activities supporting the study/project.
· Ensure reported trial data is accurate and complete and participate in all clinical data processes, as needed.
· Developing proficiency within clinical research.
· Conducts tasks and assignments as directed.
· Flexibility to accommodate off-site sponsor assignments, as needed.
· Works under direct to moderate supervision with some latitude for independent judgment.
MINIMUM POSITION QUALIFICATION REQUIREMENTS:
· Science or health-related Bachelor’s degree (or equivalent experience) preferred. RN or Medical Technology degree desirable.
· 4 years of medical device clinical experience or equivalent combination of experience and education experience preferred.
· Excellent communication (written and verbal) and strong interpersonal skills.
· Strong customer service skills.
· Strong organizational skills and detail orientation.
· Ability to travel 60% (percentage of travel will fluctuate, depending on individual client’s needs).
Internal Number: CRA II
About RCRI, Inc.
RCRI is a leading provider of strategic consulting and integrated clinical trial services to the medical device, IVD, biologics, and combination product industries. RCRI is ISO 9001:2000 certified.
At RCRI, senior consultants, principals, and specialists collaborate extensively, enabling employees to use their education and experience to help clients achieve their goals while developing their own careers as well.
RCRI offers a high-energy work environment, flexible schedules, a competitive wage and benefits package, and the opportunity to expand both your knowledge and professional skills with project variety.
RCRI offers a progressive work environment including medical, dental, disability, long-term care, and life insurance, and retirement benefits, as well as a generous paid-time-off program. Salaries are competitive and commensurate with experience.