Senior Clinical Research Associate - Americas

2 days ago

🇺🇸 United States – Remote

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🔬 Research Analyst

Apply Now

Receive Emails with Similar Jobs

Allucent

WebsiteLinkedInAll Job Openings

Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. • We are looking for a Sr. Clinical Research Associate (sCRA I) to join our A-team (remote, with travel). • As a sCRA I at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. • Therapeutic Area: CAR-T and/or stem cell • Governs highest possible quality standards for trial monitoring activities. • Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. • Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines. • Performs efficient site management in line with study budget. • Prepares and submits quality Site Visits Reports and Contact reports. • Maintains and updates CTMS in compliance with SOPs and study-specific directives. • Acts as Document Owner for collected documents. • Conducts co-monitoring as needed. • Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). • Liaises with project team members and Sponsor to track study progress and milestones. • Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. • May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). • May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. • May perform assessment visits. • Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. • Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. • Acts as the lead contact in case several CRAs involved for a same study in same country. • Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. • May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. • May participate in meetings with clients. • May support project manager/CTL and project functional leads in the project oversight and management. • Supports site staff in preparation for study related site audits and inspections. • Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.

Requirements

• At least five years clinical monitoring experience and/or relevant clinical trial experience. • Relevant life science degree / medical / nursing background, or combination of education and experience. • Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures. • Strong written and verbal communication skills including good command of English and local language. • Representative, outgoing and client focused. • Ability to work in a fast-paced challenging environment of a growing company. • Administrative excellence • Proficiency with various computer applications such as Word, Excel, and PowerPoint required. • Effective clinical monitoring skills (all kind of visits mastered): • Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. • In-depth knowledge of clinical trials and the critical elements for success in clinical trials. • Excellent understanding of the drug development process. • Ability to proactively identify and resolve issues in a timely manner. • Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. • Effective organizational and time management skills. • Ability to manage multiple projects and strong attention to detail. • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. • Ability to meet project requirements. • Proven flexibility and adaptability. • Ability to work in a team or independently and to effectively prioritize tasks. • Ability to perform travel an average of 8 days on site per month, depending on project needs.

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms