Assistant CRA in Romania

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Assistant Clinical Research Associate Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.


As part of our global team youll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate youll provide support with 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. You may be assigned limited site contact activities during study start-up site management recruitment and close-out phases.

What Youll Do:
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 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.
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.
Supports maintenance of vendor trackers as directed.
Coordinates study/site supply management during pre-activation and subsequentcourse of the study.
Supports Essential Document 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.
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 CRA and as per Task Matrix.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience Requirements:
Bachelors degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0 to 2 years).
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
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



Working Conditions and Environment:
Work is performed most of the time in an office or home office environment.; occasional travel toclinics/hospitals may be required.
Exposure to electrical office equipment.
The Assistant CRA role does not involve regular travel however any direct promotional opportunities in the CRA career track will require frequent travel (60-80%).

Required Experience:

Junior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1