Cro Work Values

Daily Duties at Cro:

• Specialist on several pharmaceutical projects for complex Phase II oncology, cardiovascular and cystic fibrosis protocols. • Trained on post marketing protocols as a quality reviewer and quality auditor. • Worked with another CRO on EDC database access and training with sponsor pharmaceutical company. • Corresponded with pharmaceutical companies over submissions of regulatory reports and critical impact on study.

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

clinical trials, pharmacovigilance, clinical monitoring, aggregate reports, PSURS, employee traing, global delivery, vendor management, site management, patient safety, adverse event reporting, case report form development, risk management, query resolution, global unblinding, medical case management, regulatory submissions, regulatory audits, protocol writing, protocol review, informed consent review, informed consent approval, study tool development, drug return, investigator recruitment, investigator selection, present at investigator meeting, 21 CRF, ICH-GCP, clinical study reports, global clinical matrix team participation, remote monitoring, pre-study visit, interim monitoring, closeout visit, study audits, regulatory query resolution, NDA approval, IND, data reconciliations, IRB submissions, medical device

Skills

pharmacovigilance, clinical trials, aggregate reports, IND subissions, PSURS, data reconciliations, protocol writing, IRB submissions, regulatory submissions, employee training, vendor management, global delivery, Presentation at investigator meetings, global unblinding of study, patient safety, medical case management, EDC databases, case report form design, investigator brochure writing, serious adverse event design, MedRa coding, writing pharmacovigilance plan, investigator brochure review, informed consent review, site audits, site selection, interim monitoring, study closeout visit, drug accountability, medical device, laboratory tests, hepatitis markers, drug labeling, PBER, drug destruction, compliance, regulatory

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