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 stud