Senior Clinical Research Associate/Clinical Research Associate II
Company: PAREXEL
Location: Salt Lake City
Posted on: September 12, 2024
Job Description:
The Clinical Research Associate is the clinical sites' direct
point of contact and accountable for managing site quality and
delivery from site identification through close-out. The aim of
this role is to build the relationship with the site, to be the
sole position accountable for the site performance, including
driving the site successfully to initiation, the development of a
robust patient recruitment strategy, setting up a system, assessing
compliance with regulations and the site's capability to comply
with the study needs and recruitment expectations, and problem
solving to address and resolve site issues.This may include various
tasks and roles within the CRA framework, contingent upon project
phase and country demands, and complexity of the study. The
Clinical Research Associate will oversee the conduct of the trial
at designated sites, ensuring the rights and well-being of human
subjects are protected, evaluating the quality and integrity of the
reported data, evaluating the site efficacy of staff training and
requiring retraining where necessary, developing strategy regarding
patient recruitment, evaluating and building the relationship with
the clinical site, using problem-solving to promote positive
working relationships with the site and staff, and ensuring the
conduct of the trial is in compliance with the currently approved
protocol/amendment(s), with GCP and with the applicable regulatory
requirement(s).Where available an "initiation Clinical Research
Associate" (iCRA) specializing in Pre SIV activities will be
assigned & accountable for managing and driving the strategy for
the Pre SIV / startup tasks of the study. The iCRA) also support
protocol amendments if applicable.Key Accountabilities:Start-up
(from site identification through pre-initiation):Act as Parexel's
direct point of contact with assigned sites, accountable for
quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or
site pre-qualification and qualification activities, which may
include:-Preparation, negotiation, and facilitation of execution of
Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs)
and any amendments.-Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site
issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and
review and approve, high quality country specific and/or site
specific documents or essential regulatory documents (SRP) and any
updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site
specific Informed Consent Forms (ICF), translations (within
parameters of country/regulatory/client requirements), and
customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable)
application(s), resolving conflicts, determining appropriate follow
up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as
per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies
for:-IRB/IEC and MoH / RA submission/approval,-Site
activation,-Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management
systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and
resolve or escalate, any site question and/or issue, including but
not limited to: potential issues or risks with site activation
timelines, issues with patient recruitment strategy, deficiencies
in training, data quality or integrity, study non-compliance,
etc.
- Facilitate and support allocated sites with access to relevant
study systems and ensure they are compliant with all project
specific training requirements prior to study start.
- Actively participate in Investigator and other external or
internal meetings, audits & regulatory inspections
- Work in a self-driven capacity, with limited need for
oversight.
- Proactively keep manager informed about work progress and any
issues.Maintenance (from initiation through close out):Act as
Parexel's direct contact with assigned sites, assess and ensure
overall integrity of study implementation and adherence to study
protocol at clinical sites, and perform problem-solving to address
and resolve site issues.
- Build relationships with investigators and site staff.
- Facilitate and support site with access to relevant study
systems and ensure sites are compliant with project specific
training requirements.
- Evaluate if on-site staff assignment is still accurate and
determine and implement corrective actions & follow-up, if
necessary / relevant.
- Address and resolve issues at sites, including the need for
additional training, potential deficiencies in documentation, and
communication.
- Address/evaluate/resolve issues pending from the previous
visit, if any.
- Follow-up on and respond to appropriate site related
questions.
- Apply working knowledge and judgment to identify and evaluate
potential data quality and data integrity issues. Determine and
implement appropriate follow-up action.
- Actively participate in Investigator and other external or
internal meetings and audits & regulatory inspections as
required.
- Collect, review, and approve (if applicable) updated/amended
site documentation, including regulatory documents as
applicable.
- Evaluate site recruitment plan in collaboration with the site
staff on an ongoing basis and provide strategy for
improvements.
- Perform on-site visits; this includes Qualification and
Initiation visits; apply judgment and knowledge to independently
resolve site issues, questions and concerns.
- Conduct remote visits/contacts as requested/needed.
- Generate visit/contact report.
- Evaluate overall compliance and performance of sites and site
staff: provide recommendations regarding site-specific actions and
use judgment and experience to assess the ability and motivation of
site staff.
- Assess & manage test article/study supply including supply,
accountability and destruction/return status.
- Review & follow-up site payment status.
- Follow-up on CRF data entry, query status, and SAEs.
- Conduct on-site study-specific training (if applicable).
- Perform site facilities assessments
- Recognize impact of study non-compliance/issues/delays/changes
on study timelines and communicate study issues that require
immediate action, with proposed strategy for resolutionOverall
Accountabilities from Site Identification to Close out:Ensure
timely and accurate completion of project goals and update of
applicable trial management systems.
- Work with team members to meet project goals, provide strategy
for efficient project planning and goal completion, and encourage
the support of team members where required.
- Update all appropriate Clinical Trial Management Systems (CTMS)
on an ongoing basis, including performing regular reviews of site
level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and
ensure timely and high quality data entry compliance from sites,
manage and submit all relevant documents to the Trial Master File
(TMF), ensuring first time quality, and distribute study documents
to site including configuration of Investigator Site Files if
applicable and on-going maintenance for completeness and
quality.
- Ensure that assigned sites are audit and inspection ready
- Monitor and maintain compliance with ICH-GCP and applicable
international and local regulations.
- Delegate administrative and other tasks to Administrative
Support Team as needed and where appropriate. Guide Administrative
Support Team members, review work, and provide feedback to manager
regarding performance.
- Show commitment and perform consistent high quality work.
- Maintain a positive, results-orientated work environment,
building partnerships and collaborative relationships,
communicating with team(s) in an open, balanced, objective manner,
modeling the high performance culture values.
- Maintain a working knowledge of and ensure compliance with
applicable ICH-GCP Guidelines, international and local regulations,
Parexel SOPs, other Parexel / Sponsor training requirements and
study specific procedures, plans and training.
- Ensure basic understanding of project scope, milestones,
budgets, and strive for high quality, timely, and efficient
delivery.
- Provide input and feedback for Performance Development
Conversation(s).
- Proactively keep manager informed about work progress and any
issues.
- Develop expertise to become a subject matter expert.
- Work in a self-driven capacity, with limited need for
oversight.
- Complete additional tasks in a timely manner (e.g. timesheets,
expenses, metrics, etc.)Skills:
- Strong problem solving skills
- Able to take initiative and work independently, and to
proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client
organization.
- Flexible attitude with respect to work assignments and new
learning.
- Ability to prioritize multiple tasks, and achieve project
timelines; utilizing strong analytical skills to make decision
autonomously due to the unpredictable nature of the issues that
arise.
- Strong ability to make appropriate decisions in ambiguous
situations.
- Willingness to work in a matrix environment and to value the
importance of teamwork.
- Strong computer skills including but not limited to the
knowledge of a Clinical Trial Management System (CTMS), Electronic
Document Management System (EDMS), and MS-Office products such as
Excel and Word.
- Excellent interpersonal, verbal, and written communication
skills.
- Sense of urgency in completing assigned tasks and ability to
assist others to meet study/country deliverables.
- Excellent time management in order to meet study needs, team
objectives, and department goals.
- Proven ability to work across cultures.
- Shows commitment to and performs consistently high quality
work.
- Ability to successfully work in a ('virtual') team
environment.
- Consulting Skills.
- Able to accommodate travel time requirements, according to
tasks allocation/phase of the study assigned.
- Act as a mentor and role model for other team members.
- Effectively enlist the support of team members in meeting
goals.
- Attention to detail.
- Holds a driver's license where required.Knowledge and
Experience:
- Substantial Site Management experience or equivalent experience
in clinical research, with understanding of clinical trials
methodology and terminologyEducation:
- Educated to degree level (biological science, pharmacy, or
other health-related discipline preferred) or equivalent nursing
qualification or other equivalent experience#LI-REMOTE
Keywords: PAREXEL, Salt Lake City , Senior Clinical Research Associate/Clinical Research Associate II, Healthcare , Salt Lake City, Utah
Didn't find what you're looking for? Search again!
Loading more jobs...