Description

Job Summary

The Supervisor Clinical Research Associate Clinical Trials Office (CTO) supervises and coordinates the day-to-day operations of a team of Clinical Research Coordinators (CRCs), Research Specialist (RS), Research Associate (RA) and others, including assignment of studies and supporting technical aspects of study management. Participates in protocol feasibility and assists with education as it relates to International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP). Works with Principal Investigators (PIs) to execute clinical research studies with human subjects at NCRI. Works with NCRI leadership to support and provide guidance on the administration of the compliance, financial, staff, and other related aspects of the clinical study, including protocol development and drafting. The Supervisor CRA will independently coordinate and support the research team and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute. Ensures processes are in place and roles are defined in order for studies to be conducted smoothly and compliantly, avoiding delays or errors with patient registration/enrollment and/or documentation and in accordance with protocol requirements. Assists study team with subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities whenever needed. Reports directly to the NCH-RI CTO Leadership and works closely with Lead CRC's, PIs, Sub-PIs, study team and additional NCRI department administrators to help ensure that clinical research and related activities are performed in accordance with all applicable Federal regulations, NCH/NCH-RI applicable policies and sponsor policies/requirements.

Job Specific Duties

• Leads and mentors a team of clinical research professionals, providing guidance, support, training, and career development.
• Oversees all aspects of clinical trial management from study start-up to closure.
• Ensures study specific training materials, documents, and records are prepared and delivered or coordinate training, dry runs, simulations and tests as required.
• Provides protocol-specific training to research study team and NCH hospital/department staff directly involved with the care/treatment of research patients.
• Identifies and implements opportunities for process improvement.
• Works with CTO Director to develop and execute processes to ensure compliance to all state and federal regulations.
• Demonstrates and leads best practices, standardized procedures, and technological improvements to streamline workflows and enhance overall trial execution
• Responsible for employee hiring, promotions, disciplinary actions, and termination in partnership with the Director.
• Works with NCH-RI staff to assist with developing, updating and implementing new Research Standard Operating Procedures, guidance documents, standard work and work flows (related to early phase research).
• Plans logistical activity for procedures as per protocol and ensures thorough resource planning. Identifies risks on study and ensures that actions are implemented to mitigate risks identified.
• Implements, monitors, and assesses the need for training programs to maintain staff skill proficiency, including annual validation and currency of required certifications and licenses.
• Coordinates and executes the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams at Nicklaus Children's and the NCH-RI.
• Interacts with patients and families to recruit study subjects and ensures compliance with protocol guidelines and requirements of regulatory agencies.
• Coordinates team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) applicable guidelines and regulations, and within budget.
• Attends and participates in investigator meetings, pre-study visits/initiation or coordinator meetings. Produces quality documentation, including completion of assessments within the specified time.
• Prepares oral presentations/written reports/data requests describing progress, trends and appropriate recommendations or conclusions as it relates to research at Nicklaus.
• Communicates with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between PI and Sponsor or Sponsor's Representatives.
• Reviews protocol and provides study feasibility input to the NCH-RI Leadership and Study Start-up Team. Works with QI/QA team to ensure quality standards are being met and reports protocol deviations.
• Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable for the reporting of events to regulatory agencies.
• Participates in the development, review and implementation of SOPs.
• Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.

Qualifications

Minimum Job Requirements

• Bachelor's degree or higher and 5 years of research experience (OR) 9 years of clinical research experience
• ACRP or SOCRA required within 6 months of hire
• IATA DGR certification completion required within 3 months of hire
• 4-7 years of experience in clinical research in an academic, hospital, CRO, or pharmaceutical company environment
• Extensive track record of accomplishment in clinical research and/or operations
• Experience in cooperative group studies
• Experience in developing and implementing productivity assessments
  

Knowledge, Skills, and Abilities

• Clinical research certification (e.g., CCRC, CCRP, CRA) preferred at hired but required within 6 months of hire date.
• Bilingual in English/Spanish preferred.
• Pediatric clinical research experience.
• Experience in neurology, neurosurgery, or oncology preferred.
• Experience with database management tools and/or REDCap preferred.
• In-depth knowledge of Phase I clinical trials.
• Demonstrated knowledge of clinical research trial design and execution.
• Experience with electronic medical record and clinical trial management software applications.
• Strong written and verbal communication skills.
• Excellent interpersonal skills.
• Excellent problem-solving skills.
• Effective organizational and project management skills.
• Ability to pay close attention to detail.
• Ability to comprehend professional and scientific journals.
• Ability to apply principles of logical and scientific thinking to a wide variety of intellectual and practical problems.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Proficiency in Microsoft Office including Access, Word, Excel, Outlook, and PowerPoint.
• Willing to work off-hours depending on the study requirements.
• Ability to demonstrate effective leadership skills and independent judgment.
• Sound judgement in applying and interpreting policies and procedures.
• Interpersonal skills necessary to establish and maintain effective working relationships with all levels of personnel throughout the organization.

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