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Responsible for directing nursing services, screening and
related functions and assisting the director with overall
management of the department. Plan, manage and monitor
workload of assigned groups to facilitate the safe and
timely completion of studies.
ESSENTIAL
DUTIES AND RESPONSIBILITIES:
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Direct nursing services, screening and related
functions. Plan, manage and monitor workload of assigned
groups to facilitate timely completion of studies.
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Assist the director with overall management of the
department, including scheduling and assignment of
studies for investigators, protocol review and
acceptance, and review/follow up on Adverse Events (AEs)
and Serious Adverse Events (SAEs).
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Assist
with preparation, conduct and follow-up for sponsor,
FDA, IRB or other regulatory audits.
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Assist with research training and study specific
training to include:
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Proper AE observation, assessment, treatment and
reporting.
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Proper medical oversight of all study participants to
assure participant safety.
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Proper ECG interpretation, lab review, chart review,
etc.
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Review and understand all contracted study protocols
assigned to team and be familiar with investigational
drug, particularly the side effect profile.
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Remain apprised of current FDA regulations, OSHA
regulations and practices and GLP/GCP guidelines and
changes. In conjunction with on-site personnel with
expertise in these areas, communicate this information
to department staff and ensure compliance with
regulations and recordkeeping requirements.
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Ensure participant satisfaction. Review study
evaluations, including through attendance at participant
feedback sessions and present and/or enact appropriate
changes.
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Manage
activities of assigned group(s) to ensure effective
performance of function.
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Interview and select qualified exempt- and non-exempt
level departmental personnel. Recommend, review and
approve personnel actions, including hiring, promotions
and raises. Partner with Human Resources in the
handling of disciplinary issues. Prepare and/or approve
appropriate personnel action paperwork.
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Identify training and development needs of direct
reports. Develop and oversee the implementation of
departmental training programs, including orientation;
monitor training programs to ensure ongoing
effectiveness.
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Monitor
performance of direct reports. Provide regular coaching
and counseling. Prepare and deliver salary and
performance reviews; review and approve performance and
salary appraisals initiated by direct reports.
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Authorize overtime as needed. Review and approve time
cards. Review and approve vacation/time off requests
and coordinate vacation/time off schedules.
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Assist
in the development of short- and long-range operating
objectives, organizational structure, and staffing
requirements. Assist in the development of a
departmental plan for backup and succession of
supervisory staff and key technical personnel.
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Assist
in the development and recommendation of departmental
budget. Authorize expenditures in accordance with
budget. Approve budget and expenses of subordinates.
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Ensure
optimum performance of group function. Determine and
implement techniques to improve productivity, increase
efficiencies, cut costs, take advantage of
opportunities, and maintain state-of-the-art practices.
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Develop
and maintain departmental systems and SOPs in accordance
with corporate policy. Assist in the development and
communication of departmental policies and procedures.
Partner with Human Resources to develop and approve job
descriptions for subordinate positions; ensure
communication of duties and responsibilities to
employees.
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Support
the policy of equal employment opportunity through
Affirmative action in all personnel actions including
but not limited to recruiting, hiring, promotions,
training, work assignments, and salary actions etc.
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Perform
all other related duties as assigned.
QUALIFICATIONS:
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Education:
Bachelor’s degree (B.A./B.S.) or equivalent in a health,
scientific or related field. Appropriate
education/training as a RN, ARNP or PA-C.
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Experience: Strong
business management background and a minimum of 10 years
experience in a research unit, service management
organization, contract research organization or an
academic research environment. Previous supervisory
experience required.
Previous experience desired in any of the following:
protocol development, clinical conduct of study, report
writing, project management or pharmacokinetics.
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An equivalent combination of education and
experience may be accepted as a satisfactory substitute
for the specific education and experience listed above.
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Certification/Licensure:
Must
have current licensure in the State of Washington as a
Registered Nurse, Certified Physician Assistant or Nurse
Practitioner. Basic Life Support certification
required.
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Other: Remain competent in clinical skills and
knowledge (i.e., ECG interpretation, IV administration,
phlebotomy and laboratory skills, etc.). Must be able
to manage medical emergencies.
Must have
excellent oral and written communication skills and a
detailed, analytical and organized orientation. Demonstrated
professional manner in dealing with co-workers,
investigators and clients. Demonstrated ability to
carry out project planning and assignments
independently, assess problematic situations and
recommend solutions.
Collaborative working style and the ability to work
effectively in a team-oriented environment.
Demonstrated working knowledge of a clinical research
center or research site environment, including
regulatory requirements regarding the protection of
human subjects through informed consent, adverse event
reporting and institutional review boards, FDA/OSHA
regulations, and GCP/GLP guidelines.
Must
be able to prioritize and manage multiple projects. Solid
computer skills, especially word processing and
spreadsheets.
Ability to maintain company and sponsor confidential
documentation.
PHYSICAL DEMANDS:
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While
performing the duties of this job, the employee is
regularly required to talk, hear and work/type at a
computer.
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Specific vision abilities required by this job include
close vision and the ability to adjust focus.
WORK ENVIRONMENT:
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General
office working conditions, the noise level in the work
environment is usually quiet.
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Occasionally exposed to fumes or airborne particles;
toxic or caustic chemicals.
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At risk
of exposure to bloodborne pathogens.
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