Job Description
At Houston Methodist, the Manager Clinical Trials position is responsible for
managing complex research projects that may involve single or multiple sites
andor research teams conducting research activities. This position directly
supervises research staff to ensure effective planning, oversight and
coordination of clinical research projects. The Manager Clinical Trials
position monitors progress and performance of all projects to include quality
of services, timelines, financial viability, compliance with federal, state
andor other regulations, laws and guidelines of Houston Methodist Research
Institute (HMRI). This position also provides guidance to department and HMRI
leadership on relevant clinical trial issues and development.
The manager position responsibilities include managing the daily work
activities of the work unitdepartment staff, ensuring quality, productivity,
functional excellence and efficiency while assisting management in
accomplishing strategic and operational objectives. In addition, this position
provides guidance to staff and is responsible for staffing, budget compliance,
contributing to staffing decisions such as hiring and terminating employment,
coaching and counseling employees on work related performance, and assisting
in the development and implementation of policies and procedures to ensure a
safe and effective work environment. This position also implements training,
monitoring and operations initiatives that secure compliance with ethical and
legal business practices and accreditationregulatory government regulations.
**PEOPLE ESSENTIAL FUNCTIONS**
* Performs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in the department. Provides development and mentoring of staff. Meets or exceeds threshold goal for department turnover. Develops direct reports to perform these same functions.
* Provides fair and consistent leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coachingcorrective counseling, and providing recognitioncommendations to achieve desired outcomes. Provides timely guidance and feedback to help others strengthen specific knowledgeskill areas needed to accomplish a task or solve a problem.
* Facilitates and promotes effective team dynamics and teambuilding strategies within and between departments; participates andor leads and facilitates department process improvements as needed.
* Meets or exceeds threshold goal for department andor system metrics on employee engagement indicators.
* Assists with on-boarding of new employees including sequencing and executing tasksactions involving Houston Methodist Research InstituteHouston Methodist Hospital (HMRIHMH) support areas (e.g. Department Orientation, Uniforms, TelecomIT, Equipment, Supplies, Training, HMRI CredentialingCompetency, etc.)
**SERVICE ESSENTIAL FUNCTIONS**
* Plans and organizes day-to-day department operations, schedule and activities. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customerpatient satisfaction.
* Drives department service standards and activities to impact department andor system score for patientcustomer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department.
* 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.
* Establishes consistent productivity expectations and revises as needed. Makes recommendations to department leadership regarding staffing requirements to meet needs of the research team to achieve maximum productivity.
* Identifies operational problems, issues and barriers across projects with input from investigators, research team members, and sponsors; communicate patterns and trends to department and HMRI leadership as appropriate; supports efforts to develop and implement processsystem improvements.
**QUALITYSAFETY ESSENTIAL FUNCTIONS**
* Ensures a safe and effective working environment; monitors andor revises the department safety plan andor any specific accreditationregulatory required safety guidelines, including infection control principles. Monitors and confirms staff maintain their required credentials that demonstrate competency per accrediting agency or department guidelines as applicable.
* Uses and optimizes information systems to enhance operations; supports entity-specific performance improvement and data managementanalysis functions.
* Employs a proactive approach in the optimization of safe outcomes by monitoring and improving the department workflow, using peer-to-peer accountability, reporting accidents, near misses, andor adverse events immediately per department protocol and identifying solutions via collaboration. Adopts lean principles in driving process improvements. Role models situational awareness, using teachable moments to improve safety.
* Monitors self and employee compliance with policies, procedures, and System HR Standards of Practice and performs associated actions upon non-compliance (i.e., focal point review requirements, disaster plan, inservices, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.).
* Monitors site visits pre-study, at study initiation, at regular intervals during the study and at study closeout.
* Conduct study operational feasibility assessments and risk assessments, along with assessing ongoing training needs of the research team.
* Monitors progress and performance of all projects including quality of services, financial viability, and compliance with federal, state, andor other regulations and laws including guidelines of HMRI.
* Assures proper study documentation is maintained and archived.
**FINANCE ESSENTIAL FUNCTIONS**
* Assists in the development of department budget and ensures that the department operates in a cost effective manner. Managesaudits department expenses within approved budget parameters, ensuring that the department meets the budgetedflex revenue andor expense targets on a monthly and annual basis. Develops staffing plans and schedules to meet departmentpatient needs that reflect understanding of the importance of cost-effectiveness.
* Implements department strategies to achieve financial target and staffing needs, developing others to do the same, through optimizing productivity, supplyresource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications.
**GROWTHINNOVATION ESSENTIAL FUNCTIONS**
* Identifies and implements innovative solutions for practice or workflow changes to improve department operations or other department-specific measures by leading unit projects andor other departmentsystem directedshared governance activities. Supports change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures.
* Proactively evaluates processes; recommends and implements action plan(s) for change; follows through to ensure effective, sustainable change. Participates in the development and implementation of new procedures and the review and revision of existing procedures.
* Identifies opportunities and takes action to build strategic relationships between ones area and other areas, teams, departments, and units to achieve business goals.
* Seeks opportunities to identify developmental needs of self and staff and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates My Development Plan (MDP) on an on-going basis. Conducts conversations with staff on their development.
This job description is not intended to be all-inclusive; the employee will
also perform other reasonably related businessjob duties as assigned. Houston
Methodist reserves the right to revise job duties and responsibilities as the
need arises.
**EDUCATION**
* Bachelors degree in scientific disciplinelife sciences (or relevant field) or nursing degree (BSN) required depending on the therapeutic area served
* Masters preferred
**WORK EXPERIENCE**
* Five years of experience within the field, of which one year must have been in a managerial role in healthcare; for internals,
* Four years of experience in relevant field with HM performance that demonstrates leadership abilities
**LICENSES AND CERTIFICATIONS - REQUIRED**
* CCRC - Certified Clinical Research Coordinator (ACRP) **OR**
* CCRP - Certified Clinical Research Professional (SOCRA) **AND**
* For HM employees, must obtain certification within 3 months ****
**KNOWLEDGE, SKILLS, AND ABILITIES**
* Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
* Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
* Ability to effectively communicate through a variety of channels with patients, physicians, family members and co-workers in a ma
Job Tags
Full time, Work experience placement, Immediate start,