Start Up Specialist Oncology

Hackensack Meridian Health•Hackensack, NJ

5d•$35

About The Position

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Start Up Specialist is responsible for the oversight and management of clinical trial start-up activities and serves as a primary contact for investigators and research coordinators for applicable divisions under the John Theurer Cancer Center (JTCC) throughout the start up process. This includes the oversight and coordination of multiple ancillary service department reviews for each protocol as well as troubleshooting delays throughout the submission and/or activation process.

Requirements

Bachelor's Degree in a science healthcare field or 2 years equivalent related experience and High School diploma, general equivalency diploma (GED), GED equivalent programs, and/or other Vocational degrees/certificates.
Mandatory education on human subject research and GCP (to be completed during training if not already completed).
Strong attention to detail and customer service focus.
Ability to work independently, and in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
Excellent communication, organizational, presentation, documentation, and interpersonal skills are required.
Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
Proficient computer skills including but not limited to Microsoft Office and Google Suite platforms.

Nice To Haves

Experience with Oncology and/or Research.
Masters degree in a related field.
Ability to Analyze Complex Situations and Identify Solutions.
Knowledge of medical/scientific terminology/concepts.
Society of Clinical Research Associates Certification or Certified Clinical Research Professional or Certified Clinical Research Coordinator.

Responsibilities

Manages all administrative/regulatory activities associated with start-up of Oncology research trials conducted at JTCC including federal, pharmaceutical funded protocols and Investigator Initiated Sponsored Trials as assigned.
Facilitates the Review and Execution of Confidentiality Agreements, Material Transfer Agreements and Clinical Trial Agreements.
Independently oversees Clinical Trial Submissions to the designated Institutional Review Board (IRB): Works with the Principal Investigator (PI) by providing administrative support to develop, implement and complete clinical trial submissions.
Prepares clinical trial documents that comply with regulatory and institutional requirements.
Submits clinical trial documents to the Scientific Review Committee and Institutional Review Board (IRB); additionally, responds on behalf of the PI, as appropriate, to comments from protocol reviewers.
Reviews and Completes Clinical Trial Essential Documents (Informed Consent Form, Designee Form, etc.) and inclusion of Institution standardized language as developed by Hackensack UMC legal.
Study entry into internal databases and routing for Physician, Study Staff and Ancillary Department Review/Approvals.
Regularly update Clinical Trial Management System on Start Up progress and effectively communicates these updates at weekly division meetings to the clinical study teams and Principal Investigators.
Effectively communicates with the budget & contract team, Research Integrity Office (RIO), Conflict of Interest Office, research nursing team, investigators, institutional officials and sponsor to ensure the timely submission of all Human Subjects Protection documents for review by the IRB of record.
Facilitates completion and submission of disease group cover letters/ rubrics for CRC review for all new treatment trials.
Serve as the resource for internal regulatory processes to assist with troubleshooting delays.
Creates metrics for streamlining processes and expediting study activation times.
Establishes timelines and manages the prompt submission of necessary materials from investigators.
Distribution of Approved Study Documentation (Trial Activation) to applicable staff.
Entry of Clinical Trial Protocol into Department's electronic tracking software, Hospital EMR System and other trial management systems, as applicable.
Work on special projects for Oncology Clinical Research as assigned by leadership.
Maintains strong lines of communication with ancillary departments and outside vendors/parties.
Reviews and complies with all relevant local, state and Federal laws and regulations.
Other duties and/or projects as assigned.
Adheres to HMH Organizational competencies and standards of behavior.