Clinical Research Associate at Novotech Boulder, CO

Benefits

Qualifications

• •Graduate in a clinical or life sciences-related field
• •Relevant experience/qualifications in allied professions may also be considered
• •Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate
• •Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
• •At least 2-3 years of Clinical Research Associate experience in the Clinical industry
• •Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
• •3 more items(s)

Responsibilities

• •Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs
• •CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials
• •Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines
• •In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed
• •In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials
• •Ensure recruitment of participants as per the site target
• •Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required
• •Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study
• •This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits
• •Visits can be conducted either onsite or remote as per CMP
• •Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs
• •Ensure safety issues are reported to the sponsor promptly
• •Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan
• •Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol
• •11 more items(s)