Cro Work Values

Daily Duties at Cro:

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines O Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies O Provides regular clinical status information to team members and project management O Performs billable work in accordance with PRA policies, procedures, and Standard Operating Procedures (SOPs) O Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff O Communicates common site trends to Lead CRA and other project team members • Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements O Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites O Ensures Serious Adverse Event (SAE) reporting according to project specifications O Responds to requests from investigative sites in a timely fashion • May serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines • Assisted as SWAT CRA in resolution of outstanding DCFs (Queries). And collected case report forms. Performed COVs, and motivational visits for non-enrolling sites. • Mentor to new CRA’s and as a Visit Leader.

What they like about Cro:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

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: