Assistant CRA

Work Schedule

Environmental Conditions

Job Description

Performs remote activities on assigned projects in liaison with the Remote CRA OnSite CRA and study CTM. Provides support with regards to 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. May be assigned limited site contact activities during study startup site Management recruitment and close out phases.

Completes study and site management activities as defined in task matrix and as applicable and advised for study assigned. Completes and documents studyspecific training. Orients and trains on any CRG/studyspecific systems. Provides inhouse support during prestudy assessments and with prestudy asssessment waivers as agreed for project.

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 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.

Supports 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.

Follows 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 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.

Basic medical/therapeutic area knowledge and understanding of medical terminology.

Knowledge Skills and Abilities Required:

• 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
• Welldeveloped critical thinking skills including but not limited to: critical mindset indepth 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