FSP - Assistant Clinical Research Associate (ACRA)

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate, you'll provide support with 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. You 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, andas applicable and directed for study assigned.

•Completes and documents 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 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.

•Supports maintenance of vendor trackers, as directed.

•Coordinates study/site supply management during pre-activation and subsequentcourse 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 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 CRA 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.

•Bachelor's degree in a life science discipline 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.

• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents

• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

• 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

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

• Exposure to electrical office equipment.

• The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

- Bachelor’s degree in life sciences, nursing, or a related field (or equivalent experience)

- Prior experience in clinical research, site management, or monitoring support (entry-level acceptable)

- Familiarity with ICH-GCP guidelines, SOPs, and regulatory requirements for clinical trials

- Excellent written and verbal communication skills for liaison with CRAs, site staff, and study teams

- Ability to support site contact activities during start-up, recruitment, and close-out phases as directed