A Cell, Inc. Work Values

Daily Duties at A Cell, Inc.:

Specific Medical Device Experience: ● Experience working with third party vendors (e.g. medical device/orthotic companies, contract research organizations (CROs) to generate budget proposals to support specific clinical trial protocol needs ● Experience initiating set up of medical device shipping and purchasing systems from sponsor to medical center for multiple sites ● Experience as clinical trial liaison between clinical research leadership, medical sites, and in house general counsel for specific clinical trial agreements (CTAs) and other contracts as specified ● Experience editing clinical trial protocols according to specific needs, timelines, and medical site review and feedback ● Experience reviewing site budgets and working with internal stakeholders to facilitate negotiations • Planning and managing of company initiated multi-site clinical trials (ranging from Pilot studies through Phase IV as assigned • Organizing, communicating, and evaluating team objectives for ongoing assigned clinical trials to ensure that study deliverables are being met and are in line with corporate expectations • Developing and editing clinical trial related documentation, including clinical research study protocols, informed consent forms, case report forms, monitoring plans, data management plans, statistical analysis plans, and IRB/IEC submissions and renewals as needed • Contributing to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs) • Conducting site initiation visits and delivering protocol dictated site-appropriate training for clinical research site staff Working with in-house legal department on non-disclosure agreements with site and vendors (as appropriate), clinical trial agreements (CTA), and clinical research organization (CRO agreements) • Organize and manage project timelines and budgets to ensure project deliverables are on time and within budget • Serving as the ACell primary contact with the clinical investigators and study coordinators for all aspects of conducting the clinical trial • Schedule and lead investigator meetings, SIVs, SMV, and close out visits • Monitor and visit clinical trial sites to ensure compliance with study protocol, GCP, and 21 CFR 812 • Coordinate with clinical investigators in the timely completion, submission, and review of CRFs • Provide support to clinical investigators and study coordinators to resolve site related issues • Overseeing device accountability and distribution and tracking clinical documentation • Review and report adverse events in conformance with FDA regulations

What they like about A Cell, Inc.:

The social vibrance of a hiring firm is very important to you. Your ability to make and maintain friendships there is a critical part of your decision. You would likely be dissatisfied with a workplace that is quiet, cold, or otherwise not particularly social. When you investigate a new hiring company, ask recruiters, managers, and potential co-workers about the social life and opportunities there. This is especially important when you are relocating; moving dramatically alters your social sphere both inside and outside the workplace.

Tags

Skills

Clinical Research Project Management, Quantitative Data Entry and Analysis, STATA, Problem Solving and Leadership, Microsoft Office, Patient Interviewing and Conducting Research Informed Consent Process, Medical Chart Data Abstraction and Review, Survey Instrument Administration, Informed Consent and Regulatory Documentation Management, Active ICH-GCP and CITI Certificates

These are some of the questions we asked our climbers about their experiences with A Cell, Inc.: