The role of the Sr. Clinical Research Regulatory Specialist - DSMB involves coordination and overseeing clerical, administrative, and data management tasks to support the various activities of the DSMB. This position is primarily remote, but in-person attendance at the biannual DSMB meetings is mandatory.

This position provides administrative assistance in organizing DSMB meetings, including handling documents and correspondence. Tasks include:

• Organizing and managing activities and communication for the St. Jude Data Safety Monitoring Board (DSMB), ensuring timely production and distribution of materials.
• Managing and storing data release requests from Investigators.
• Conducting committee orientation and collecting Conflict of Interest disclosures from DSMB members.
• Arranging travel and accommodation for DSMB members for biannual meetings and supporting hybrid meetings.
• Collaborating with the DSMB Executive Secretary and, when necessary, Chair of the DSMB to facilitate coordination activities for protocol referrals and ensure timely preparation of DSMB reports
• Processing approved amendments for DSMB review
• Maintaining up-to-date distribution lists for DSMB membership
• Coordinating with St. Jude Senior Leadership administrative support to ensure their attendance at DSMB meetings.
• Assisting the Executive Secretary of the DSMB in preparing and distributing meeting minutes according to DSMB procedures.
• Facilitate communication with external Data Safety Monitoring Boards (DSMBs) (research study specific), acting as a liaison between the Principal Investigator (PI)/ study team (biostatistician) and the Executive Secretary for communication with external DSMB contacts when necessary.
• As needed, serve as a point of contact for external DSMBs for St Jude Sponsored trials with external DSMB oversight.
• Supporting Human Research Protection Program initiatives and projects as needed
• Attending biannual DSMB meetings in person.

The ideal candidate must effectively carry out all essential duties to excel in this position. The qualifications below reflect the necessary knowledge, expertise, and skills for success.

Desired Qualifications:

• Proficiency in multitasking while managing multiple projects simultaneously.
• Exceptional communication abilities and the capacity to collaborate with individuals at all levels, both internally and externally
• A proactive self-starter with strong organizational skills and adept at time and project management
• A dedicated focus on providing excellent customer service
• Demonstrates a creative, cooperative, and problem-solving approach to tasks.
• Proficient in MS Office applications (Word, Excel, Outlook, and PowerPoint) at an intermediate to advanced level
• Demonstrates sound judgment and discretion.
• Previous experience in coordinating conferences and meetings is preferred.
• Familiarity with clinical trial procedures is advantageous.
• A Bachelor's degree is required for this role.

Minimum Education and/or Training:

• Bachelor's degree in relevant area required.

Minimum Experience:

Minimum Requirement: 4+ years of experience in related field (e.g., quality, regulatory affairs, human research protection program compliance, or policymaking in government or pharma industry)

• Proven performance in earlier role.

Compensation

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Diversity, Equity and Inclusion

St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. .

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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