- Perform remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA, and study CTM.
- Provide support for 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 start-up, site management, recruitment, and close-out phases.
Key Responsibilities:
- Complete study and site management activities as defined in task matrix, and as applicable and advised for the study assigned.
- Complete and document study-specific training.
- Orient and train on any CRG/study-specific systems.
- Provide in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for the project.
- Support the customization of Site ICF with site contact details, as needed.
- Perform remote review of EMR/EHR checklist and support collection, as applicable.
- Verify document collection and RCR submission status; update site EDL and verify site information.
- Review patient-facing materials and translations, as directed.
- Support site staff with the vendor-related qualification process, where applicable.
- Ensure system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
- Follow-up on site staff training, as applicable.
- Coordinate and support logistics for IM attendance, as advised.
- Maintain vendor trackers, as advised.
- Coordinate study/site supply management during pre-activation and subsequent course of the study.
- Collect, review, and update crucial documents in systems, as applicable.
- Follow up on missing study vendor data like ECGs, lab samples, and e-diaries, as advised.
- Support ongoing remote review of centralized monitoring tools, as advised.
- Coordinate with various functional departments and sites for site payment processes.
- Perform reconciliation tasks on assigned trials, including but not limited to CRF and query status, deviations, SAEs, and safety reports, as applicable.
- Verify document collection status in CRG systems and drive action for missing/incomplete/expired documents and open document findings, as advised.
- 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.
- Complete administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience:
- Bachelor’s degree 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).
Knowledge, Skills, and Abilities:
- Basic medical/therapeutic area knowledge and understanding of medical terminology.
- Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations, and CRG procedural documents.
- Effective oral and written communication skills.
- Excellent interpersonal and customer service skills.
- Good interpersonal and time management skills, with strong attention to detail.
- Proven flexibility and adaptability.
- Ability to work in a team or independently, as the need arises.
- Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis, and problem-solving.
- Proficient digital literacy with good knowledge of MS Office and the ability to learn and use appropriate software.
- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS, and dashboards.
- Excellent English language and grammar skills.