IMMEDIATE SITE START UP SPECIALIST WITH LEADING ONCOLOGY ACADEMIC RESEARCH CENTER IN NEW JERSEY Description:
Manages all administrative/regulatory activities associated with start-up of Oncology research trials conducted at Client 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 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.
Additional Skills & Qualifications:
Bachelor's Degree in a science healthcare field
2 years equivalent related experience and High School diploma, general equivalency diploma (GED), GED equivalent programs, and/or other Vocational
Mandatory education on human subject research and GCP (to be completed during training if not already completed).
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.