Lead-Clinical Research Associate

The Infectious Diseases Department is looking for a passionate individual to join our HIV Prevention and Treatment Team. The ideal candidate will be highly experienced in clinical trials start-up and implementation. They will be able to mentor and train on facilitating start-up and study conduct activities. They must also be well organized, confident, and have excellent communication and presentation skills. Collaboration will be key in the success of this position.

Job Responsibilities:

• Lead institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.
• Provide clinical operations expertise to inform clinical trial operational feasibility and delivery, and development of study recruitment and retention strategies.
• Collaborate with pharmaceutical services, study teams, and external stakeholders to forecast study drug needs and develop study-specific supply chain operational plans.
• Participate in/guide contract drafting, negotiation, administration and renewal; resource/supply management; budget development and management for clinical trials/studies; and financial tracking and follow-up (e.g., reimbursements) for assigned projects.
• Guide engagement between cross-functional teams (e.g., regulatory, finance, biosafety, IS), cross-institutional teams, and external groups (e.g., FDA, NIH) for effective execution of trials/studies.
• Drive stakeholder meetings for assigned trials/studies (e.g., PI meetings, CRO trainings, vendor meetings, collaborative study site meetings).
• Monitor project progress and site performance, communicate regular updates to leadership teams/key stakeholders, and address risks and delays.
• Oversee compliance of assigned projects with regulatory requirements and institutional policies.
• Train and mentor teams around clinical trial conduct and project management/coordination.
• Assist in development of standard operating procedures, and implementation of process improvements where feasible.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Minimum Education and/or Training:

• Bachelor’s degree in relevant area required.
• Master’s degree preferred.

Minimum Experience:

• Minimum Requirement: 5+ years of progressive experience in related area (e.g., study design, clinical project management, research study management).
• Experience Exception: Master’s degree and 3+ years of experience.
• Prior clinical, academic, behavioral, pharmaceutical, biomedical, scientific, or related experience.
• Prior experience in coordinating clinical trials/studies in academic center, hospital, or pharmaceutical industry (as applicable).
• Clinical research background strongly preferred.
• Experience leading complex systems/processes/projects in a technical capacity.
• Experience implementing optimization/innovation of institutional systems/processes related to clinical research studies within area.
• Proven performance in earlier role.

Licensure, Registration and/or Certification Required by SJCRH Only:

• SOCRA or ACRP certification strongly preferred, or willingness to obtain within 3 months of starting the position.

Special Skills, Knowledge and Abilities:

• Able to draw insights from different sets of data and quickly understand why issues are happening.
• Solves problems quickly by identifying the right causes.
• Encourages others to see the opportunities ahead with changing circumstances even when the details have not been finalized.
• Leads team meetings on a need basis and effectively communicates with cross-functional teams for results.
• Understands and uses digital tools of communication as needed.
• Speaks up in meetings, raises concerns, and shares information with team.
• Leverages knowledge of clinical project management tools and methodologies to manage institutional clinical programs/trials/studies.
• Defines scope and milestones clearly for assigned projects and oversees critical program aspects (e.g., contracting, budgeting, resourcing, supply chain).
• Identifies critical program/study stakeholders (e.g., cross-functional teams, cross-institutional teams, external groups) and consistently communicates project progress.
• Advises, guides, and mentors project teams to drive accountabilities.
• Ensures adherence to timelines and GCP guidelines during the conduct of protocol implementation and data collection.
• Leverages knowledge of study and site considerations to provide ongoing direction for assigned studies within own area (research management/operations).
• Understands study interdependencies, and consistently communicates with critical stakeholders to drive execution, escalating as needed.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $86,320 – $154,960 per year for the role of Lead-Clinical Research Associate.

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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. Learn more about our history and commitment.

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 Diversity, Equity and Inclusion Report to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

St. Jude is an Equal Opportunity Employer

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