Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Trainee Clinical Research Associate (CRA) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA, and study CTM. As a Trainee Clinical Research Associate, you'll 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 You’ll Do:
•\tCompletes study and site management activities as defined in task matrix, and as applicable and advised for study assigned.
•\tCompletes and documents study-specific training.
•\tOrients and trains on any CRG/study-specific systems.
•\tProvides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
•\tSupports to customize Site ICF with site contact details, as needed.
•\tPerforms remote review of EMR/EHR checklist and supports collection, as applicable assessments.
•\tVerifies document collection and RCR submission status; updates site EDL and verifies site information.
•\tReviews patient facing materials and review translations, as directed.
•\tSupports site staff with the vendor related qualification process, where applicable.
•\tProvides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
•\tProvides support to follow-up on site staff training, as applicable.
•\tCoordinates and supports logistics for IM attendance, as advised.
•\tSupports maintenance of vendor trackers, as advised.
•\tCoordinates study/site supply management during pre-activation and subsequent course of the study.
•\tSupports Crucial Document collection, review and updating in systems, as applicable.
•\tFollows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as advised.
•\tSupports ongoing remote review of centralized monitoring tools, as advised.
•\tSupports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as advised and follows-up on site invoices throughout the study period.
•\tPerforms reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
•\tVerifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as advised.
•\tMay perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
•\tMay perform a specific role profile for FSP opportunities according to Client requests.
•\tMaintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience:
•\tBachelor's degree or equivalent and relevant formal academic / vocational qualification
•\tPrevious 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:
•\tBasic medical/therapeutic area knowledge and understanding of medical terminology
•\tAbility to attain and maintain a solid understanding of ICH GCP, applicable regulations and CRG procedural documents
•\tEffective oral and written communication skills
•\tExcellent interpersonal and customer service skills
•\tGood interpersonal and time management skills and strong attention to detail, with proven track record to handle multiple tasks efficiently and optimally
•\tProven flexibility and adaptability
•\tAbility to work in a team or independently, as the need arises
•\tWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
•\tProficient digital literacy with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
•\tAbility to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
•\tExcellent English language and grammar skills