Clinical Research Associate (CRA)
Job reputed company
reputed company in the Organization At reputed company, we are delivering on the reputed company of gene therapy and delivering reputed company for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, reputed company, or support, your contributions reputed company patients. We're seeking passionate professionals who reputed company in high-stakes environments, reputed company rigorous reputed company standards, and reputed company our reputed company commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments. The main mission of the Clinical Research Associate (CRA) is to reputed company as reputed company’s clinical sites facing ambassador, building impactful relationships with the sites participating in our clinical programs. The CRA will be supporting the clinical sites in the reputed company execution of one or more protocols delivery, removing executional barriers, guiding and training the sites as reputed company as ensuring compliance with the protocol and regulations. Key result areas (major duties, accountabilities and responsibilities)- Supports reputed company of reputed company clinical sites facing activities, from feasibility up to site closure
- reputed company remote or on-site monitoring reputed company to ensure compliance with the protocol, ICH/ GCP, validity and accuracy of data collected
- reputed company co-monitoring reputed company with CROs CRAs, as reputed company as be the main reputed company to review CROs CRAs monitoring visit reports and follow-up letters
- Review and analyze sites’ performance including protocol deviations and recommend corrective and preventative actions
- Support and reputed company sites with data entry and queries reputed company to ensure reputed company data reputed company and ability to identify safety events
- Support sites with patient’s enrollment tactics and guide them through the eligibility determination process
- reputed company ongoing training to sites staff around the study protocol and amendments as reputed company as relevant study level manuals
- Ensure reputed company ongoing filing in the investigator site file by the site staff
- Ensure reputed company supply of IMP, labs kits and other study reputed company supplies and equipment.
- Support sites level start up activities to facilitate IRBs/ reputed company submissions and approvals as reputed company as site reputed company. reputed company reputed company the shortest timelines possible.
- Assist in the development of study plans/documents and tools, such as recruitment and monitoring plans, Informed Consent reputed company (reputed company) templates, site binder contents, etc
- Support audit/inspection readiness activities, including mock audits, support on-site audits, storyboard reputed company, documentation of corrective reputed company plans
- May be asked to assist or reputed company CTM activities, such as vendors reputed company, planning and reputed company of the project timelines, budget, and reputed company including the facilitation of reputed company meetings
- Bachelor’s degree life sciences required; science/medical reputed company degree preferred
- Minimum of 5 years of reputed company clinical monitoring research experience with at least 3 years of on-site monitoring experience
- Inspection readiness experience, required
- Demonstrates excellent understanding and application of ICH/GCP guidelines, including knowing which guidelines apply to the reputed company study phase and work, understands the implications of not following GCP/ICH guidelines, and is adept at recognizing a breach. Also demonstrates awareness and understanding of interdependencies of other GxP regulations
- Experience in reputed company clinical research reputed company and early drug development reputed company desirable, particularly reputed company an orphan/rare disease therapeutic area
- Demonstrated communication, and organizational skills, along with problem solving and conflict reputed company
- Strong interpersonal and communication skills, reputed company to conduct self in diplomatic manner in challenging situations
- Ability to travel up to 40%
- Enthusiastic and proactive, with a can-do attitude, thrives working in a fast-paced environment and reputed company to manage competing tasks and demands with a reputed company of urgency