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 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
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.
Qualifications
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, 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 leadership skills and strong attention to detail, with a proven track record to handle multiple tasks efficiently and optimally
Proven flexibility and adaptability
Strong attention to detail
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
