PPD Las Condes Chile
2 months ago
Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.
• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
• Completes and documents study-specific training
• Orients and trains on any company/study-specific systems
• Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project
• Supports to customize Site ICF with site contact details, as needed
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments
•... Verifies document collection and RCR submission status; updates site EDL and verifies site information
• Reviews patient facing materials and review translations, as directed
• Supports site staff with the vendor related qualification process, where applicable
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study
• Provides support to follow-up on site staff training, as applicable
• Coordinates and supports logistics for IM attendance, as directed
• Support with maintenance of vendor trackers, as directed
• Coordinates study/site supply management during pre-activation and subsequent course of the study
• Supports Essential Document collection, review and updating in systems, as applicable
• Follow up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed
• Supports ongoing remote review of centralized monitoring tools, as directed
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable
• Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed
• May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix
• May perform a specific role profile for FSP opportunities according to Client requests
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience:
Bachelor's Degree in a life science-related field or relevant/equivalent formal academic/vocational qualification
Clinical research experience would be an advantage
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven flexibility and adaptability
• Strong attention to detail
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills
PPD clinical research services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application – we'd love to hear from you
Las Condes Chile
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