What are the responsibilities and job description for the Clinical Data Coordinator - Now Hiring position at Actalent?
Description:
• Provides knowledge and expertise in one of the following areas and performs with minimal input from the supervisor.
• Reviews, analyzes and implements regulatory and CRS requirement for study, amendment and research study document submissions to the SRC and IRB.
• Reviews, analyzes and implements study data requirements; enters study data into the CRS electronic research database.
• Reviews, analyzes and implements methods for study data management and fulfills data requests in a timely manner.
• Reviews, analyzes and implements study compliance methods and procedures including submitting CR/PR documents to the IRB, preparing and submitting INDs and IEDs to the FDA, registering study participants, ensuring that all study requirements are in place prior to study release for implementation.
• Maintains internal and external websites and other tracking methods to ensure study compliance.
• Assists reviews and verifies study budget components, study contracts and study grants before and during study implementation.
• Verifies that all study requirements and issues are resolved prior to study activation and during study implementation.
• Maintains and updates all research related databases post meetings, e‐mails, and all other communication.
• Maintains study records by recording and filing all study records and regulatory documents.
• Creates updates and maintains the CRS Standard Operating Procedures for all CRS systems and procedures.
• Interacts with the Investigators, Clinical Research staff, Roswell Park departments and staff and study sponsors regarding study requirements.
• Uses, maintains and updates the clinical research internal and external websites.
• Submits INDs and annual reports to the FDA.
• Provides education and mentorship for the Clinical Research Associate I’s.
• Suggests and implements improved methods for accomplishing research goals.
• Attends and actively participates in CRS meetings
Additional Skills & Qualifications:
• Associate’s degree in a health or science related field and the equivalent of two (2) years of full‐time research experience.
BS degree is also ideal
• Must be proficient in Microsoft Office computer applications.
• Must have an extensive understanding and practical knowledge of statistical methodologies and expertise in the study of design and data analysis.
• Must have excellent organization skills.
• Must have strong medical/clinical background and must be well‐versed in anatomy and physiology.
• Must have strong statistical and analytical skills.
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $18 - $0
