Cro Work Values

Daily Duties at Cro:

All aspects of clinical trial conduct Phase II to III (Bioequivalence and Comparative Studies): Development, implementation, methodology, planning, functioning, operation, support and preparation of: project initiation, budget / contract proposals, regulatory affairs, subject enrollment, data analysis and evaluation of outcomes. Compose, write and design protocols, monitoring plans, informed consent forms (ICF) and study reports. For both in and out patient studies: Supervise Site Selection, Site Initiation, Interim Monitoring and Close Out Visits, Sponsor and FDA Audits, Quality Assurance (QA) and Quality Control (QC) Audits, GCP, GLP, GMP, Project Management and Drug Safety. Train, supervise, teach, guide and advise on clinical, medical and scientific aspects of patient treatment, protocol strategy, regulatory requirements, clinical supply projection and production, data management expectations and adherence, understanding of ICH / FDA / GCP / SOP guidelines, outstanding customer service, quality, collaboration, ethics and integrity at all levels of project. Develop effective standardisation and validation processes inline with all regulatory regulations for all equipment and data. Effective skilled communication at all levels including Investigators, vendors, monitors, data, IRB, Sponsor client and project team members. Prepare timely, accurate and detailed study progress and monitoring reports. Track clinical study progress and outcomes. Ensure clinical vendor supplies, packaging, budget and delivery. Prepare expense reports, manage time, and schedule subsequent visits in accordance with sponsor expectations and within the budget. Organize and assign tasks, review and sign off on all visit reports. Co-monitoring to assist in training of monitors and naïve sites. Experienced in monitoring large number of sites, protocols and subject numbers. Serve as a resource for providing timely accurate current knowledge expertise and information in all aspects of the project conduct. Work closely with all associated project team, multitasking to ensure timely resolution of project and clinical issues, communicate common site trends and perform investigative site file reconciliation. Review content of all relevant documents for accuracy, consistency and compliance with appropriate local regulatory requirements and sponsor requirements, perform source document verification, retrieve (CRFs) and perform query resolution in a timely manner, identify deficiencies and discrepancies; provide additional training and initiate corrective action as required. Oversee drug safety and accountability; ensure Adverse Event and Serious Adverse Event (SAE) reporting according to project specifications, respond to requests from associated departments within timeframe. Communicate to Key Opinion Leaders and relevant personnel scientific concepts, clinical objectives, commercial opportunities, introduce and develop new product awareness. Develop, maintain and coordinate relationships with relevant personnel. Provide presentations to relevant key opinion leaders and all relevant personnel clinical data and off-label product use. Attend industry conferences and meetings and assist in the selection of clinical sites for clinical studies.

What they like about Cro:

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

TRIALs

Skills

Versatile, multi-tasking, flexible, cross-functional team player or independent with immediate SWAT stat if required., Computer literacy: WORD, PowerPoint, and Excel, eCRF/Electronic Data Capture: RAVE, Siebel/CTMS, Data Labs, MediData, ClinPhone, IXRS and IVRS., Experience with total study management conduct support: budget/ contract proposal, regulatory affairs, GCP, GLP, GMP, IRB, ICH, FDA, DEA, vendors, drug accountability, audits, subject enrollment, data analysis, site feasibility, site selection, subject e, Supervisory/Mentoring/ Training Experience: Trainer for any study as a Visit Leader and trained new employees in medical terminology at former job.

These are some of the questions we asked our climbers about their experiences with Cro: