As an Assistant Clinical Research Associate (CRA), you will perform remote activities on assigned projects in collaboration with the Remote CRA, On-Site CRA, and study Clinical Trial Manager (CTM). Your responsibilities include providing support for site preparedness, logistical assistance to the monitoring process, and aiding with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines. You may also be involved in limited site contact activities during various study phases.
Key Responsibilities:
- Complete study and site management activities as defined in the task matrix for assigned studies.
- Document study-specific training completion.
- Orient and train on CRG/study-specific systems.
- Provide in-house support during pre-study assessments and waivers.
- Customize Site Informed Consent Forms (ICF) as needed.
- Perform remote review of EMR/EHR checklist and support data collection.
- Verify document collection and submission status.
- Review patient-facing materials and translations.
- Support site staff with vendor-related qualification processes.
- Coordinate system access for relevant site staff.
- Coordinate logistics for Investigator Meetings (IM).
- Support maintenance of vendor trackers.
- Coordinate study/site supply management.
- Support Crucial Document collection, review, and updating.
- Follow up on missing study vendor data.
- Support ongoing remote review of monitoring tools.
- Assist with site payments processes.
- Perform reconciliation tasks on assigned trials.
- Perform other assigned site management tasks as directed.
Keys to Success:
Education and Experience:
- Bachelor’s degree or equivalent.
- 0 to 2 years of relevant experience.
Knowledge, Skills, and Abilities:
- Basic medical/therapeutic area knowledge.
- Understanding of medical terminology.
- Familiarity with ICH GCP and applicable regulations.
- Effective oral and written communication skills.
- Excellent interpersonal and customer service skills.
- Strong attention to detail and time management skills.
- Proven flexibility and adaptability.
- Ability to work independently or in a team.
- Critical thinking skills for problem-solving.
- Proficient in MS Office and digital literacy.
- Ability to extract pertinent information from various sources.
- Excellent English language and grammar skills.
