The Clinical Trials Manager supports complex research projects that may involve sites and/or the management of research activities. Directly supervises research staff to ensure effective planning, oversight and coordination of clinical research projects. Monitors progress and performance of all projects to include quality of services, timelines, compliance with federal, state and/or other regulations, laws and guidelines of The Methodist Hospital Research Institute. This position also provides guidance to department and TMHRI leadership on relevant clinical trial issues and developments.
PATIENT AGE GROUP SERVED
Indirect Patient Care
DUTIES AND RESPONSIBILITIES
' Manages the daily operations of a clinical research team.
' Monitors progress and performance of all projects including quality of services and compliance with federal, state and/or other regulations and laws including guidelines of The Methodist Hospital Research Institute.
' Serves as a liaison between investigators and ancillary departments, research subjects and sponsoring organizations.
' Manages study start-up activities including protocol submission to relevant committees and regulatory documents to study sponsor.
' Assists with clinical trial budget development and reconciliation of research accounts; ensures that CTMS is updated by staff regularly.
' Implements complex research projects, including screening and enrolling subjects, and conducting testing procedures required by study protocol (medical history interview, vital signs, collect and enter data into case report forms, reporting to study monitors), Prepares presentations and schedules institutional training for physicians, nurses and staff on research protocol.
' Provides patient education regarding disease process and involves patient and family in decision-making processes.
' Manages the efforts of clinical research staff including hiring, performance management, scheduling of work assignments, disciplinary action, promotions, and transfers.
' Establishes consistent productivity expectations and revise as needed. Makes recommendations to department leadership regarding staffing requirements to meet needs of the research team to achieve maximum productivity.
' Assists with on-boarding of new employees including sequencing and executing tasks/actions involving TMHRI/TMH support areas (e.g., Department Orientation, Uniforms, Telecom/IT, Equipment, supplies, training, TMHRI Credentialing/Competency, etc.).
' Assesses ongoing training needs of research team.
' Identifies operational problems, issues and barriers across projects with input from investigators, research team members, and sponsors; communicate patterns and trends to Department and TMHRI leadership as appropriate; supports efforts to develop and implement process/system improvements.
' Prepares reports for department and TMHRI leadership.
' Participates in regular department operations meetings.
' Participates on institutional committees and task forces as required.
Maintains a professional and credible image with FDA and other regulatory agencies, Sponsors, vendors, patients and co-workers.
Displays ICARE values.
Performs other duties as assigned.
Bachelor of Science degree in natural sciences or relevant field required.
Advanced Degree preferred.
Minimum of five years of relevant research program experience required.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
CCRC (Certified Clinical Research Coordinator) or equivalent certification preferred.
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Excellent working knowledge of FDA regulations and GCP guidelines.
Excellent written and oral communication skills.
Strong ability to direct and train employees, to include organizing, prioritizing, and scheduling of work assignments.
Strong ability to multi-task and highly organized with strong attention to detail and highly effective time management skills.
Strong analytical skills.
Document management skills.
Proficient computer skills.
' Activity Checklist attached (see final page)
' Patient care unit conditions
' Operating room conditions
' Universal precautions required
' Lifting, pushing or pulling required (minimum 50 lbs.)
' Extended periods of walking and standing required
' Significant potential for exposure to Latex
- 3 years ago - save job