Lead Clinical Research Associate

The Worlds Best Stop at Nothing

Theres a reason St. Jude Childrens Research Hospital is consistently ranked on Glassdoors Best Places to Work list. Actually there are more than 6500 reasons. At our world-class pediatric research hospital every one of our 6500 professionals shares our commitment to making a difference in the lives of the children we serve. Theres a unique bond when you are part of a team that will stop at nothing to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative positive environment where all employees regardless of their role receive the resources support and encouragement to advance and grow their careers.

The Lead-Clinical Research Associate is responsible for performing data abstraction collection and entry to support clinical research. Develops maintains and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data and reports to the collaborating research organization or study sponsor.

Work location: *Primarily on site*

This position will require leadership skills from a Lead CRA who can work collaboratively across departments coordinate multiple external collaborating sites and manage the logistics of clinical trial patients from referring clinics. This position will require in-depth knowledge of clinical trials multi-center regulatory logistics and provide guidance to junior team members.

Job Responsibilities:

• 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
• 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).
• 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:

• Bachelors degree in relevant area required.
• Masters degree preferred.
• RN 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: Masters 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 Law:

• None

Licensure Registration and/or Certification Required by SJCRH Only:

• None

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.

Physical Demands and Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job the employee is regularly required to stand; walk; sit; kneel use hands to finger handle or feel; and talk or hear.
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision depth perception and the ability to adjust focus.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.
• An essential function of the job is to be able to comply with all applicable federal state and local safety and health regulations that would apply to this job.
• The employee must move about the work space to access work surface and shelves cabinets drawers and equipment that are at below or above the work surface.
• Nothing in this job description limits managements right to assign or reassign duties and responsibilities to this job at any time as business needs dictate. This job description reflects managements assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned. The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job nor is it intended to be an all-inclusive list of the skills and abilities required to do the job.

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 $86320 - $154960 per year for the role of Lead Clinical Research Associate.

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