Assistant Cra - Bogota, Colombia - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Bogota, Colombia

hace 1 semana

Publicado por:

Carolina González

beBee Recruiter

Descripción

Our team of colleagues in clinical research services are at the forefront of getting cures to market.

We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns.

Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global contract research organization (CRO).

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 studyspecific training
Orients and trains on any company/studyspecific systems
Provides inhouse support during prestudy assessments and with prestudy 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 preactivation and subsequent course of the study
Provides support to followup 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 preactivation 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 ediaries, 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 followsup 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 sciencerelated 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: