Assistant Cra

3 semanas atrás

Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

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, logístical 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.

Essential Functions:

- 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 att

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