Assistant CRA FSP

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:
Performs remote activities on assigned projects in liaison with the CRA and study Clinical Lead. 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 start-up site management
recruitment and close out phases.

Completes study and site management activities as defined in task matrix and
Functions as applicable and advised for study assigned.
Completes and details study-specific training.
Orients and trains on any 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 advised.
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 advised.
Supports maintenance of vendor trackers as advised.
Coordinates study/site supply management during pre-activation and subsequent
course of the study.
Supports Crucial 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 advised.
Supports ongoing remote review of centralized monitoring tools as advised.
Supports 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.
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.

EducationandExperience:
Bachelors degree in a life science rigor or related field or a Registered Nursing certification 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).
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.
KnowledgeSkills andAbilities:
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a solid understanding of ICH GCP applicable regulations and company
procedural documents
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good interpersonal and time management skills and strong attention to detail with shown ability to
balance multiple tasks efficiently and optimally
Shown flexibility and adaptability
Ability to work in a team or independently as the need arises
Well-developed critical thinking skills including but not limited to critical attitude in-depth
investigation for appropriate root cause analysis and problem solving
Proficient digital literacy 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 skill