Senior CRA (Remote)
Posted on: January 25, 2023
PXL FSP is hiring a Senior Clinical Research Associate (SCRA)
Position Purpose: The Senior Clinical Research Associate (SCRA) is
responsible for the following: Act as the primary site contact and
site manager throughout all phases of a clinical research study,
taking overall responsibility of allocated sites. Organizational
Relationships: Reports to ExecuPharm (EP) assigned Line Management
with day-to-day direction from Client. Refer to Organizational
Chart for details regarding assigned role and associated reporting
structure. Works in partnership internally with Global Clinical
Trial Operations (GCTO) country operations, finance, regulatory
affairs, pharmacovigilance, legal and regional operations,
Headquarter (HQ) functional areas and externally with vendors,
Institutional Review Boards, Institutional Ethics Committees and
Regulatory Authorities in support of assigned sites. Primary
Responsibilities: Develops strong site relationships and ensures
continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in
compliance with Good Clinical Practice (GCP) / International
Council for Harmonization (ICH), Sponsor SOPs, Local Laws &
Regulations, Protocol, Site Monitoring Plan, and associated
documents. Gains an in-depth understanding of the study protocol
and related procedures. Coordinates & manages various tasks in
collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation
activities. Performs remote and on-site monitoring & oversight
activities using various tools to ensure: o Data generated at site
are complete, accurate and unbiased o Subjects'' right, safety and
well-being are protected Conducts site visits including but not
limited to validation visits, initiation visits, monitoring visits,
close- out visits and records clear, comprehensive, and accurate
visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation
for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to
protocol conduct, recruitment, retention, protocol deviations,
regulatory documentation, site audits/inspections and overall site
performance. Identifies, assesses, and resolves site performance,
quality or compliance problems and escalates per defined CRA
Escalation Pathway as appropriate in collaboration with Clinical
Research Manager (CRM) and Partner Line Manager (PLM), Manages and
maintains information and documentation in Clinical Trial
Management System (CTMS), Electronic Trial Master File (eTMF) and
various other systems as appropriate and per timelines. Contributes
strongly to CRA team knowledge by acting as process Subject Matter
Expert (SME), sharing best practices, making recommendations for
continuous improvement, and providing training as
appropriate/required. Supports and/or leads audits/inspection
activities as needed. Mentors / buddies junior CRAs on
process/study requirements. Contributes to initiatives and projects
adding value to the business. Performs co-monitoring as
appropriate. Completes training assigned by Client and/or
ExecuPharm (EP), as necessary, including general training
requirements, SOPs, and system and process related training.
Adheres to EP and Client SOPs and processes. Education and
Certification: B.A./B.S. preferred with a strong emphasis in
science and /or biology. Skills and Experience: Minimum 4 years of
direct site management (monitoring) experience in bio/pharma/CRO.
Note: No compromise on minimum monitoring experience however
specific monitoring or therapeutic experience/requirements may vary
depending on the Country or study needs. Excellent understanding
and working knowledge of clinical research, phases of clinical
trials, current GCP / ICH and country clinical research law and
guidelines. Hands on knowledge of Good Documentation Practices.
Excellent understanding of Global, Country/Regional Clinical
Research Guidelines and ability to work within these guidelines.
Demonstrated ability to mentor/lead. Proven skills in Site
Management including independent management of site performance and
patient recruitment. Demonstrated high level of monitoring skill
with independent professional judgement. Good IT skills (Use of MS
office, use of various clinical IT applications on computer, tablet
and mobile devices) and ability to adapt to new IT applications on
various devices. Ability to understand and analyze data/metrics and
act appropriately. Experience with conducting site motivational
visit designed to boost site enrollment. Capable of managing
complex issues, works in a solution-oriented manner. Performs root
cause analysis and implements preventative and corrective action.
Capable of mentoring junior CRAs on process/study requirements and
is able to perform co-monitoring visits where appropriate.
Effective time management, organizational and interpersonal skills,
conflict management, problem solving skills. Able to work highly
independently across multiple protocols, sites, and therapy areas.
High sense of accountability / urgency. Ability to set priorities
and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment; ability to
establish and maintain culturally sensitive working relationships.
Demonstrates commitment to customer focus. Works with high quality
and compliance mindset. Positive mindset, growth mindset, capable
of working independently and being self-driven. Demonstrates and
projects professional demeanor and communication consistent with
organizational policies and practices. Language Skills: Fluent in
local languages and English (verbal and written) and excellent
communication skills, including the ability to understand and
present technical information effectively. Other Requirements:
Ability to travel domestically and internationally approximately
65%-75% of working time. Expected travelling -2-3 days/week.
Current driver''s license required. LI-REMOTE
Keywords: PAREXEL, Mansfield , Senior CRA (Remote), Other , Mansfield, Texas
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