Assistant Cra - Tlahuac, México - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Tlahuac, México

hace 3 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Performs remote activities on assigned projects in liaison with the Remote CRACTM.

Provides support with regards to site preparedness, logístical support to and assist with assigned tasks for site management and remote monitoring in regulatory guidelines.

May be assigned limited site contact activities during stumanagement, recruitment and close out phases.

Essential Functions
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
asssessment 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 appplicable.
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 per Task Matrix.
May perform a specific role profile for FSP opportunities according to Clienrequests.
Maintains & completes administrative tasks such as expense reports and
timesheets in a timely manner.

Education and Experience:

revious 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 and 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
Excellent English language and grammar skills

Management Role:

No management responsibility

Working Conditions and Environment:

Work is performed most of the time in an office or home office environment.; occasional travel to
clinics/hospitals may be required.

Exposure to electrical office equipment.

Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movementsof the fingers, hands, and wrists.

Occasional mobility required.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Occasional light lifting and/or carrying of objects with a maximum lift of 5-15 lbs. (2-6 kgs.)
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so