Manager Clinical Trials - Structural Heart Dis_Interv
Company: Houston Methodist Academic Institute
Location: Houston
Posted on: October 8, 2024
Job Description:
At Houston Methodist, the Manager Clinical Trials position is
responsible for managing complex research projects that may involve
single or multiple sites and/or 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 and/or 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 unit/department 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 accreditation/regulatory/ 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,
coaching/corrective counseling, and providing
recognition/commendations to achieve desired outcomes. Provides
timely guidance and feedback to help others strengthen specific
knowledge/skill areas needed to accomplish a task or solve a
problem.
- Facilitates and promotes effective team dynamics and
teambuilding strategies within and between departments;
participates and/or leads and facilitates department process
improvements as needed.
- Meets or exceeds threshold goal for department and/or system
metrics on employee engagement indicators.
- Assists with on-boarding of new employees including sequencing
and executing tasks/actions involving Houston Methodist Research
Institute/Houston Methodist Hospital (HMRI/HMH) support areas (e.g.
Department Orientation, Uniforms, Telecom/IT, Equipment, Supplies,
Training, HMRI Credentialing/Competency, 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 customer/patient satisfaction.
- Drives department service standards and activities to impact
department and/or system score for patient/customer-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 process/system improvements.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
- Ensures a safe and effective working environment; monitors
and/or revises the department safety plan and/or any specific
accreditation/regulatory 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
management/analysis 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,
and/or 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, and/or 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.
Manages/audits department expenses within approved budget
parameters, ensuring that the department meets the budgeted/flex
revenue and/or expense targets on a monthly and annual basis.
Develops staffing plans and schedules to meet department/patient
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, supply/resource efficiency, minimizing
incidental overtime and overtime percentage, and other areas
according to department specifications.
GROWTH/INNOVATION 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 and/or other
department/system directed/shared 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 one's 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 business/job
duties as assigned. Houston Methodist reserves the right to revise
job duties and responsibilities as the need arises.
EDUCATION
- Bachelor's degree in scientific discipline/life sciences (or
relevant field) or nursing degree (BSN) required depending on the
therapeutic area served
- Master's 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 manner consistent with a customer service focus and
application of positive language principles; engages the
recipient(s) and helps them understand and retain the message
- Demonstrates the ability to interact with others in a way that
gives them confidence in one's intentions and those of the
organization
- Ability to use appropriate interpersonal styles and techniques
to gain acceptance of ideas or plans; modifying one's own behavior
to accommodate tasks, situations and individuals involved
- Demonstrates leadership qualities and critical thinking through
self-direction initiative and effective interpersonal skills and
oral/written communication skills
- Ability to identify and understand issues, problems and
opportunities, comparing data from different sources to draw
conclusions; using effective approaches for choosing a course of
action or developing appropriate solutions; taking action that is
consistent with available facts, constraints and probable
consequences
- Ability to work effectively in a fast paced environment
- Demonstrates flexibility and adaptability in the
workplaceSUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
- Uniform No
- Scrubs Yes
- Business professional Yes
- Other (department approved) NoON-CALL*
*Note that employees may be required to be on-call during
emergencies (ie. DIsaster, Severe Weather Events, etc) regardless
of selection below.
- On Call* YesTRAVEL**
**Travel specifications may vary by department**
- May require travel within the Houston Metropolitan area
Yes
- May require travel outside Houston Metropolitan area YesCompany
Profile:Houston Methodist Academic Institute oversees the Education
Institute and Research Institute, including 772 faculty and 56,250
learners. The Academic Institute aligns our research and education
initiatives in service to the clinical mission, providing solutions
that answer the call for new technologies and skills our clinicians
need for patient care.
Houston Methodist Education Institute coordinates our primary
academic affiliation with Weill Cornell Medicine and other joint
programs, including the Engineering Medicine Program at Texas
A&M University Intercollegiate School of Engineering Medicine.
The Education Institute also oversees continuing medical education
and graduate medical education, and supports more than 1,000
trainees in residence for medical, nursing, allied health and
research education programs.
Houston Methodist Research Institute supports research programs and
infrastructure that enable faculty across the system to bring new
scientific discoveries to patients as rapidly as possible through
the full cycle of a cure from conceptual bench research, to
prototyping and development, to clinical trials and FDA approval.
The Research Institute supports more than 1,387 clinical research
protocols and $70.3 million in extramurally funded translational
research programs.Houston Methodist is an equal opportunity
employer inclusive of women, minorities, disabled persons and
veterans.Equal Employment OpportunityHouston Methodist is an Equal
Opportunity Employer.Equal employment opportunity is a sound and
just concept to which Houston Methodist is firmly bound. Houston
Methodist will not engage in discrimination against or harassment
of any person employed or seeking employment with Houston Methodist
on the basis of race, color, religion, sex, sexual orientation,
gender identity, national origin, age, disability, status as a
protected veteran or other characteristics protected by law. VEVRAA
Federal Contractor - priority referral Protected Veterans
requested.
Keywords: Houston Methodist Academic Institute, Pearland , Manager Clinical Trials - Structural Heart Dis_Interv, Accounting, Auditing , Houston, Texas
Didn't find what you're looking for? Search again!
Loading more jobs...