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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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
- Innovative
- Problem-Solver
- Communicator
- Tech-Savvy
- Confident
- Independent
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Compensation
Competitive salaries and bonus structure based on individual metrics.
Responsibilities
The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance. This role also contributes to site selection, provides local intelligence, ensures site support, resolves issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks.
Key Accountabilities:
Site start-up and activation
- Deploys client site strategies by qualifying and activating assigned sites
- Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selection
- Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision
- Maintains a knowledge of assigned protocols
- Conducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation
- Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
- Supports country specific ICF review and deployment up to Site Activation
- Ensures follow up activities’ completion post Site qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV)
- Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV
- Responsible for relationship building and operational quality of the site
- Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners
- Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.)
- Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study
- Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct
- Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry up to Site Activation
Intelligence gathering
- Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
- Provides support to study management to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies
Study conduct and close-out
- Reviews Site Reports and related issues
- Assures quality and consistency in the delivery of monitoring
- Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management
Compliance with Parexel standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements
Skills:
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Good communication, presentation, and interpersonal skills
- Ability to manage required travel
- Demonstrated networking and relationship building skills
- Demonstrated ability to manage cross functional relationships
- Ability to communicate effectively and appropriately with internal & external stakeholders
- Ability to adapt to changing technologies and processes
- Knowledge of country requirements for GCP that may be different to those of client procedures
- Effectively overcoming barriers encountered during the implementation of new processes and systems
- Identifies and builds effective relationships with investigator site staff and other stakeholders
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Able to manage issues that are escalated by site staff in a way that meets the needs of both the client and the site staff
Knowledge and Experience:
- Demonstrated experience in site management with prior experience as a CRA in Oncology
- Demonstrated experience in start-up activities through site activation
- Demonstrated experience in conduct and close out activities
- Demonstrated knowledge of quality and regulatory requirements in applicable countries
Education:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)
- Proficiency in local language preferred. English is required
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