Premier Research is looking for a Senior Clinical Research Associate (Contract) to join our Clinical Monitoring, Site Management and SSU team.
Join us and build your future here.
What You'll Be Doing:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan(CMP)timelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity andsubjectsafety in accordance withlocal/regional laws andcountryspecificregulations
- Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
- Prepares for and conducts onsiteand/or remotequalification, study initiation, interim monitoring,dosing observation,and closeout monitoring visitsasdirected per CMP
- Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
What We Are Searching For:
- Preferred Therapeutic Areas: Oncology, CNS, Dermatology, and Rare Disease monitoring experience highly prioritized
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Patient facing, study coordinating experience preferred
- Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practicesappropriate tothe country/region where site monitoring activities will be conducted
- Ability to multitask and work effectivelywith technology and peoplein a fast-paced environment with changing priorities, self-starter
- Travel up to 70-85%
- This is a full-time contract position for 12 months.
