The Senior Clinical Research Coordinator RN supports the field activities for the conduct of clinical research studies in compliance with applicable regulatory standards, IRB policies, procedures and internal requirements.
Have an integral role in verifying data from multicenter clinical trials.
Reports directly to the Clinical Research Director with whom he/she will collaborate on the responsibilities for verification of data collection on grant-funded cardiovascular and neurovascular clinical trials.
Responsible for independently scheduling site monitoring (review source documentation, case report forms, electronic date entered and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the protocols, investigational plans, monitoring plans, applicable regulatory, IRB standards, guidelines and policies. While onsite, will review all trial device and/’or product accountability as necessary.
Creates written reports of all monitoring activities to document on site visits including data integrity, newly discovered adverse events and follow action items through to resolution.
Assist with study start up and study closure activities such as site initiations and study close out conference calls and or site visits.
Assist with compilation of adverse events, source documentation and preparation for Event Adjudication Committee meetings as needed.
May assist with data management activities for clinical studies, as required.
May assist in the development of protocol defined data collection case report forms.
Develop policies and procedures within area of responsibility.
Participate in conferences, meetings and seminars concerning research and surveillance projects to enhance knowledge base.
Participate in regular teleconferences and staff meetings.
Timely responses to site questions are imperative, therefore personal digital assistant (e.g., Blackberry) will be provided.
Mentors, trains and reviews the work of less experienced clinical research monitoring staff.
Performs other related duties.
Must have excellent computer skills , MS and other applications.
Reports to Director, Clinical Research
Bachelor's degree in nursing or related field. Master's degree preferred
5 years of clinical research Excellent written and oral communication skills
Exceptional attention to detail and accuracy
Ability to manage multiple tasks & priorities
Demonstrated leadership potential
Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds.
Mount Sinai Medical Center--An EEO/AA-D/V Employer.
Mount Sinai Medical Center - 19 months ago
Mount Sinai Medical Center