assistant CRA

About the Role

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

As an Assistant CRA (ACRA), you combine knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions, and deliver results.

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose

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.

A Day in the Life

• Completes study and site management activities as defined in task matrix, and as applicable and advised 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 assessment 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 advised.
• 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 advised.
• Supports with maintenance of vendor trackers, as advised.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Supports Ess Crucial current collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed advised.
• Supports ongoing remote review of centralized monitoring tools, as directed advised.
• Supports Site payments processes by coordinating with various functional departments within organization and site.
• Supports system updates and reconciliations, as directed advised.
• 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 advised.
• May perform other assigned site management tasks, as advised 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.

Keys to Success

Education

• Bachelor’s Degree in a life science-related field or relevant/equivalent formal academic/vocational qualification.
• Clinical research experience would be an advantage.

Experience

• 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, Abilities

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a solid understanding of ICH guidelines and local regulations.
• Ability to attain and maintain a solid understanding of PPD’s SOPs and WPs.
• Ability to attain and maintain a solid understanding of the study protocols.
• Ability to attain and maintain a solid understanding of the EDC, IXRS, and other relevant study systems.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent verbal and written communication skills.
• Strong organizational and time management skills.
• Ability to work independently and as part of a team.
• Attention to detail and accuracy.
• Problem-solving skills.
• Ability to adapt to changing priorities and deadlines.