Site Care Partner I
India, Remote Job ID R0000029686 Category Clinical Trials Date Posted 01/07/2025Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
About This Role
Responsibilities
Accountable for site start-up and activation:
- Deploy GSSO 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 & provide PTA output for site selection.
- Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.
- Maintain a thorough knowledge of assigned protocols
- Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
- Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
- Support country specific ICD review and deployment when applicable
- Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
- Partners with site monitor to ensure site monitoring readiness in anticipation of first subject first visit
- Responsible for relationship building and operational oversight of the site
- Provide 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.)
- Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
- Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.).
- Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
Accountable for study conduct and close-out
- Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
- Review Site Monitoring Reports
- Support the site with revision and submission of ICD documents (and amendments).
- Working with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.
- During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current.
- Review and manage site practices that differ from Client practices and liaise with study management and Business Process Owners as needed.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.
- Assure quality and consistency in the delivery of monitoring
- Drive monitoring efficiencies and best practices for study/region/program
- Support shaping the local clinical development environment with a goal to enhance Client reputation in scientific leadership.
- May act as a Subject Matter Expert on Client systems and processes.
- Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships
- Ensures clear and open communication with Study Operations Manager
- Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management.
Responsible for proactively providing local intelligence
- Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
- Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.
Qualifications
Training and 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
Prior Experience
- Demonstrated experience in site management with prior experience as a site monitor
- Demonstrated experience in start up activities through to site activation
- Demonstrated experience in conduct and close out activities
- Demonstrated knowledge of quality and regulatory requirements in applicable countries
Technical Competencies
- 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 of up to 75% on a regular basis
- 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
Behavioral Competencies
- 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
#LI-REMOTE
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
