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About the Role
As an Assistant Clinical Research Associate, you will perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. 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.
Responsibilities
- 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 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 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 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.
Requirements
- 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.
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company 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
Skills
- Medical terminology
- ICH GCP
- Applicable regulations
- Company procedural documents
- Oral communication
- Written communication
- Interpersonal skills
- Customer service skills
- Organizational skills
- Time management skills
- Attention to detail
- Flexibility
- Adaptability
- Teamwork
- Independent work
- Critical thinking
- Problem solving
- MS Office proficiency
- Computer proficiency
- Information extraction
- English language proficiency
- English grammar proficiency
Location
- Office
- Home office
Work Type
- Standard (Mon-Fri)
- Remote activities
Experience Level
- 0 to 2 years
Education Level
- Bachelor's degree in a life science discipline or related field
- Registered Nursing certification
- Equivalent and relevant formal academic / vocational qualification
About the Company
- 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.