Clinical Research Associate I-Neurosurgery-13001-001

Description
The Clinical Research Associate I position will be responsible for study monitoring, regulatory compliance, and protocol training under the Department of Neurosurgery Academic Research Organization (ARO).
Responsibilities
Roles and Responsibilities

• Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review). Coordinate all data query resolutions.
• Conduct independent remote monitoring in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory standards, IRB, and Mount Sinai policies and procedures. Monitoring will include a review of essential documents, investigational product records, and subject records. Communicate monitoring findings with local and external site study personnel via monitoring reports and correspondence for follow-up in accordance with the study Monitoring Plan.
• Review and approve external sites’ consent forms before external site IRB submission
• Maintain trackers of study visits, regulatory documentation, contacts lists, and site statuses
• Identify and escalate protocol deviations, discrepancies in data, and noncompliance to study protocols, applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures. Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance. Collaborate with PIs and research coordinators in creating corrective and preventive action plans. Collaborate with regulatory teams or project managers to maintain Florence eBinders compliance
• Meet expected timelines for completion of monitoring activities and submission of written monitoring reports
• Provide recommendations and guidance to study specific teams and assist in audit readiness and preparation
• Work with ARO data management team to ensure that all external sites have appropriate access to REDCap and Florence eBinders
• Participate in regular ARO team meetings and weekly monitoring check-ins
• Develop a Monitoring Plan for each study (e.g., percentage of records to be reviewed, frequency of review and plan for escalation of review). Develop and maintain policies, standard operating procedures, and monitoring tools/worksheets. Provide input on case report forms and other study documents

Qualifications

• 1-2 years of relevant clinical research experience, preferably at least 1 year clinical trial monitoring or CRC experience
• Experience working with CTMS and eTMF systems
• Background in clinical trial experience required
• Bachelors Degree in life sciences or BSN.

Compensation Statement
The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for this role is $58,661.00 - $81,675.00 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Non-Bargaining Unit, 842 - Neurosurgery - ISM, Icahn School of Medicine
Employer Description
Strength Through Diversity
The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:

• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.
• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.

We work hard to acquire and retain the best people and to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to professional advance. We share the belief that all employees, regardless of job title or expertise contribute to the patient experience and quality of patient care.
Explore more about this opportunity and how you can help us write a new chapter in our history!
Who We Are
Over 42,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai Morningside ( Formerly St Luke’s), and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression.
EOE Minorities/Women/Disabled/Veterans
Compensation
The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $58661 - $81675 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.