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The Mount Sinai Health System Clinical Research Associate I-Neurosurgery in New York, New York

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

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).

Roles and Responsibilities

STUDY MONITORING

  • 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.

  • Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review). Coordinate all data query resolutions.

  • Meet expected timelines for completion of monitoring activities and submission of written monitoring reports

  • 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

  • Provide recommendations and guidance to study specific teams and assist in audit readiness and preparation

  • Participate in regular ARO team meetings and weekly monitoring check-ins

  • 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

  • Review and approve external sites’ consent forms before external site IRB submission

  • Maintain trackers of study visits, regulatory documentation, contacts lists, and site statuses

  • Work with ARO data management team to ensure that all external sites have appropriate access to REDCap and Florence eBinders

REGULATORY AND COMPLIANCE

  • Collaborate with regulatory teams or project managers to maintain Florence eBinders compliance

  • Review and approve external sites’ consent forms before external site IRB submission

  • Maintain trackers of study visits, regulatory documentation, contacts lists, and site statuses

  • Work with ARO data management team to ensure that all external sites have appropriate access to REDCap and Florence eBinders

SITE INITIATION VISITS (SIV) AND OTHER TRAINING

  • Issue feasibility assessments as necessary

  • Conduct site initiation visits and electronic data capture trainings to ensure that all collaborating sites and respective staff have a thorough understanding of the study protocol

  • Collaborate with local and external sites to schedule site initiation visits and electronic data capture trainings. Email confirmation letters and agendas prior to trainings.

  • Complete SIV report and send follow up SIV letters to sites

  • Work in partnership with external sites to collect CVs, medical licenses, Good Clinical Practice training certificates, neurological assessment certifications, and any other ancillary documents required for study compliance

  • Lead any closeout activities by verifying that all regulatory documents and data are completed

Education:

  • Bachelor’s Degree

Experience:

  • 1-2 years of relevant clinical research experience, preferably at least 1 year clinical trial monitoring or CRC experience

  • Background in clinical trial experience required

  • Experience working with CTMS and eTMF systems

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity and inclusion are drivers for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together and participate actively as a leader within the Mount Sinai Health System by:

  • Serving as the primary resource management representative of the Mount Sinai leadership teams, committees, etc., and acting as the primary executive leader interface between Mount Sinai and key executives from the health systems’ vendors and partners.

  • Engaging with relevant thought leaders and policy-makers at the federal and state levels, and representing the Health System as assigned.

  • Using a lens of equity in establishing and promoting policies and procedures and providing opportunities for all to thrive.

  • Confronting racist, sexist or other inappropriate behavior and challenges exclusionary organizational practices and serving as a role model to promote anti-racist behaviors.

  • Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.

Explore more about this opportunity and how you can help us write a new chapter in our story!

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 hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai Morningside (formerly Mount Sinai 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

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