Remote Clinical Trial Manager
Company: Beacon Hill Staffing Group
Location: Houston
Posted on: June 25, 2022
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Job Description:
SUMMARY: Responsible for operational aspects of planning and
management of site performance in accordance with departmental
expectations. May act as primary liaison between in-house CRAs,
field based CRAs and the Clinical Project Manager (CPM). Supports
and assists Clinical Project Managers in operationalizing multiple
clinical research studies.
RESPONSIBILITIES:--- Under supervision may participate/lead in CRA
project-specific training.--- Supports preparation and development
of materials related to the training and presentations for
Investigator Meetings.--- Facilitates CRA project meetings.---
Assist in the oversight of monitoring staff including the tracking
and review of monitoring trip reports and escalate any trends with
respect to data quality or study conduct to the appropriate CPM.
--- Track and report on progress of the study including site
activation, patient enrollment and monitoring visits.--- Ensures
that all sites are provided supplies in accordance with study
expectations.--- Identify potential risks to the enrollment targets
based on feasibility analysis in collaboration with the CPM---
Develop PSV /SIV/IMV presentation and other training tools and
training materials in support of the project.--- Review and approve
PSV/SIV/IMV presentation and other training tools and training
materials in support of the project.SR CTM--- Assist in the review
of CRO and other third party vendor invoices to ensure that work is
performed in accordance with scope of work.--- Ensure that
monitoring visits are performed in accordance with the protocol,
monitoring plan, and applicable company SOPs. --- Under supervision
may develop and/or monitor budget for clinical study
(investigational sites and vendors) --- Responsible for
operationalizing clinical protocols at the site level and ensuring
appropriate SOPs are being followed for each process, depending on
the study. --- Assists in oversight of the identification and
selection of investigator sites.. --- Contributes to the clinical
review of Case Report Forms, User Acceptance Testing (UAT) and
corresponding completion guidelines.--- Assists and/or participates
in planning and conduct of investigator's meetings--- Work with
CRAs in proactively maintaining / up-dating essential documents as
required, to ensure compliance with protocol and regulations.---
Contact sites as needed for data entry/data quality concerns and
alert CRA of any issues prior to the next scheduled monitoring
visit.--- Responsible for study start-up activities including
development of the first draft of the ICF. --- Assist with the
review of protocol, protocol amendments, ICF and CSR documents as
required.--- Provide active mentorship of CTA staff to build talent
across the department.--- Agenda distribution & minute taking for
internal study team meetings. --- Up to 20% domestic and/or
international travel may be required.QUALIFICATIONS:--- Bachelor's
degree or nursing qualification is required. Scientific/health care
field preferred, but not required. --- Experience (4 to 6 years)
working in relevant clinical research preferably in clinical
operations within a pharmaceutical company or CRO or similar
organization.--- Requires strong attention to detail in composing
and proofing materials, establishing priorities, scheduling and
meeting deadlines. --- Must be able to work in a fast paced
environment with demonstrated ability to juggle multiple competing
tasks and demands. --- Ability to work successfully within a
cross-functional team. --- Strong knowledge of applicable computer
and project management software packages. --- Excellent written and
oral communication skills. --- Ability to interact with
investigators, vendors, and internal colleagues. CTM--- Strong
communication skills for interactions with investigators, vendors,
and internal colleagues.--- Knowledge of current regulatory
requirements and guidelines governing clinical research and GCP ---
Ability and identifying tasks and deadlines to resolve/escalate
problems in a timely manner
Keywords: Beacon Hill Staffing Group, Houston , Remote Clinical Trial Manager, Healthcare , Houston, Texas
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