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 CRG/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 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.
Supports 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.
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 CRG 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.
Job Complexity: Works on problems of limited scope.
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Job Knowledge: Learns to use professional concepts.
Applies company policies and procedures to resolve routine issues.
Supervision Received: Normally receives detailed instructions on all work.
Business Relationships: Contacts are primarily with immediate supervisor, and other personnel in the department.
Builds stable working relationships internally.
Qualifications
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
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, 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 CRG 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
