100% REMOTE - Clinical Operations Lead
Posted on: February 21, 2021
Description:JOB SUMMARYThe Clinical Operations Lead (COL) serves
as the clinical functional lead, accountable for the clinical
monitoring/site management delivery of assigned study(ies). The
position as defined by scope provides leadership, mentoring, and
technical support to the Clinical Operations team to ensure quality
of deliverables and achievement of financial goals. May provide
administrative line management, which includes oversight of
training, compliance, performance and career management, and
development of direct reports.JOB RESPONSIBILITIES
- Ensures quality of the clinical monitoring and site management
deliverables within a project and maintain proper visibility of its
progress by the use of approved systems and / or tracking tools.
May include the development of the Clinical Management Plan
(CMP)/Site Management Plan (SMP).
- Interacts with the client and other functional departments
related to clinical monitoring and site management activities and
- Ensures alignment of clinical activities to budget, including
identification of out of scope activities.
- May participates in business development proposals, defense
meetings and proposal development.
- As required, provides development and delivery of initial and
ongoing training to the study team regarding protocol
specificities, Case Report Form (CRF) completion, Sponsor Standard
Operating Procedures (SOPs), clinical plans and guidelines, data
plans and timelines for the study. Plans and leads regular clinical
study team calls to provide status updates, ongoing training and
accountability to deliverables.
- May evaluate staff's competency to perform visits/site contact
independently via sign-off visits and Performance Assessment Visits
(PAVs) according to company standards and process.
- Adheres to scope and routinely reviews Clinical Trial
Management System (CTMS), Case Report Form (CRF), drug management,
safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data
Visualization dashboards (where available) to oversee site and
study team conduct, to ensure timely entry of all operational
aspects (required visits/calls, duration, and frequency) according
to plan, and to oversee site and study team conduct and identify
any risks to delivery or quality.
- Reviews the content and quality of site monitoring
documentation (site monitoring calls, site visit reports, site
letters, and pertinent correspondence), to ensure they represent
site management activities and conduct. Ensures these deliverables
are provided according to company and/or sponsor specifications,
including delivery deadlines.
- Understands the monitoring strategy required for the study and
where required participates in the development of the study risk
assessment plan. Is accountable for the clinical teams
understanding, ongoing compliance and delivery according to the
stated monitoring strategy, CMP/SMP, and risk plans.
- Adheres to scope to ensure assigned clinical staff routinely
assess site processes, perform review of all Source Documents and
medical records, and perform Source Document Verification (SDV) per
the CMP/SMP and reviews identified and newly emerging risks.
Develops and executes corrective action plans at site and study
level, proportionate to the risks identified. Utilizes systems and
tools to assess Key Risk Indicators (KRIs) and ensures that
monitoring visits/calls are occurring in line with CMP/SMP.
Proactively collaborates with the data management functional lead
to plan towards data cut and lock deadlines.
- Collaborates with other functions to ensure site compliance and
delivery according to protocol, ICH/GCP and or Good
Pharmacoepidemiology Practices (GPP) and country regulations,
including medical monitoring, Safety, Quality Assurance (QA).
Ensures Inspection Readiness for Clinical Scope.Additional Skills &
- Bachelor's degree or RN in a related field or equivalent
combination of education, training and experience
- Demonstrated ability to lead and align teams in the achievement
of project milestones, demonstrated capability of working in an
- Knowledge of basic clinical project financial principles
- Knowledge of Good Clinical Practice/ICH Guidelines and other
applicable regulatory requirements
- Must demonstrate good computer skills
- Excellent communication, presentation and interpersonal
- Ability to apply problem solving techniques to resolve complex
issues, and apply a risk management approach to identifying and
mitigating potential threats to the successful conduct of a
clinical research project.
- Demonstrates critical thinking to determine the cause and
appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20% About
Aerotek:We know that a company's success starts with its employees.
We also know that an individual's success starts with the right
career opportunity. As a Best of Staffing Client and Talent leader,
Aerotek's people-focused approach yields competitive advantage for
our clients and rewarding careers for our contract employees. Since
1983, Aerotek has grown to become a leader in recruiting and
staffing services. With more than 250 non-franchised offices,
Aerotek's 8,000 internal employees serve more than 300,000 contract
employees and 18,000 clients every year. Aerotek is an Allegis
Group company, the global leader in talent solutions. Learn more at
Aerotek.com.The company is an equal opportunity employer and will
consider all applications without regards to race, sex, age, color,
religion, national origin, veteran status, disability, sexual
orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, Cary , 100% REMOTE - Clinical Operations Lead, Healthcare , Morrisville, North Carolina
Didn't find what you're looking for? Search again!