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February

Initiation Clinical Research Associate Ii

Parexel - Australia,

Health, Medical & Pharmaceutical
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.

As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Full Time
Level: Mid
Travel: Yes
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Check out the top traits we’re looking for and see if you have the right mix.

Innovative
Problem-Solver
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Tech-Savvy
Confident
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Rewards
Global Impact

We are one truly global team working together to propel each client´s journey ahead faster.

Balance

We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

Collaboration

Work with industry leaders and subject matter experts.

Freedom

The ability to innovate, ask “what if” and try new solutions without fear of failure.

Variety

Opportunities to work on multiple accounts - never boring!

Compensation

Competitive salaries and bonus structure based on individual metrics.
The Initiation Clinical Research Associate (iCRA) is the 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. Specializing in Pre SIV activities, accountable for managing and driving the strategy for the Pre SIV / startup tasks of the study. The iCRA also support protocol amendments if applicable. The iCRA will be responsible for preparing the initial site related IRB application and associated documents required prior to SIV and reviewing and approving all essential documents (SRP, ICF etc.). Post SIV the iCRA would review / approve the documents as determined by Parexel SOPs (e.g. SRP & ICF).

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: o 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: o 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
  • Work in a self-driven capacity, with limited need for oversight.
  • Proactively keep manager informed about work progress and any issues.
  • 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.
Qualifications

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
Knowledge and Experience:
  • Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Education:
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience