Supv II ClinOps
Company: Labcorp Drug Development - USA
Location: Madison
Posted on: March 19, 2023
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Job Description:
Responsible for ensuring that all practical aspects of clinical
studies are conducted to the highest possible quality and in
accordance with the protocol, SOPs and ICH/GCP standards. Provides
leadership, training, coaching and mentoring for study staff.
Duties and Responsibilities: - Directly supervises staff which may
consist of RNs, LVN/LPNs, and Research Technicians. - Current
knowledge of ICH/GCP standards. - Demonstrate ability to lead by
example and to encourage team members to seek solutions. - Ensure
that the safety, welfare and dignity of research subjects are not
compromised. - Ensure the quality of service provided by team
members meets the requirements of both internal and external
clients. - Instill in all team members responsible to him/her the
Company's commitment to quality and meeting the client's
requirement without error, on time, every time. - Play an active
role in the development and implementation of Quality within
his/her area of responsibility. - Assist with the coordination of
relevant protocols. - Ensure that appropriate training programs are
in place so that all personnel under his/her supervision are
adequately and properly trained for their job requirements. -
Ensure that all training files are up to date and complete in
accordance with SOPs and ICH/GCP. - Ensure all work in his/her area
is carried out in strict accordance with relevant protocols, SOPs,
and in compliance with ICH/GCP. - Ensures that the CRF product
meets the customer expectations. - Assist with planning of study
set up, as needed. - Ensure that the staff under his/her
supervision area at all times adequate in quality and quantity to
meet the agreed forecasted workload. Recommend changes if necessary
and justify them in accordance with company policy. - Ensure that a
safe working environment is maintained and that safe working
practices are employed. - Ensure that full and accurate data
records are maintained. - Keep management up to date on all aspects
of his/her job and initiate improvements. - Manage his/her area so
as to meet the budgeted standard of performance. - Respond
constructively to management and QA ensuring that any GCP/ICH
deficiencies are followed up with prompt remedial action. -
Performs supervisory duties including but not limited to
interviewing, hiring, training, intervention, discipline, and
discharge of operations staff. - Coaches and mentors staff.
Initiates, plans and implements appropriate staff development
programs. - Ensures that up to date manuals of SOPs and Policy and
Procedures are available to all personnel in his/her work area. -
Schedules investigators for protocol-related tasks. - Updates or
creates SOPs/P&Ps germane to their area of expertise. -
Schedules staff as appropriate for clinic requirements. - Complies
with departmental meeting schedules. - Assists, as necessary, with
study procedures. - Tracks and evaluates Interdepartmental Monthly
Key Result Indicators. - Works on a wide range of opportunities and
problems where use of creative thinking and the application of
related quality and continuous improvement theories and principles
is required. - Continuously seeks out new and better ideas, driving
best practices. Educational Qualifications: - BS in science or
medical field or LPN, LVN or AD degree Experience: - 3 years
related experience including 1-2 years of research experience with
a BS degree. - 5-7 years of related experience including 1-2 years
of research experience with a LPN, LVN or AD degree - Additional
experience may be substituted for education. Labcorp is proud to be
an Equal Opportunity Employer: As an EOE/AA employer, the
organization will not discriminate in its employment practices due
to an applicant's race, age, color, religion, sex, national origin,
sexual orientation, gender identity, disability or veteran status.
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Keywords: Labcorp Drug Development - USA, Madison , Supv II ClinOps, Other , Madison, Wisconsin
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