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 for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

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: