The Clinical Quality Control Oversight Representative, Clinical Operations will coordinate and perform the comprehensive Quality Control Oversight (QCO) activities of CRO managed investigative sites. As needed, may also perform site management of Shionogi clinical trials.
Oversee and evaluate CRO monitoring activities through electronic data capture (Medidata Rave), electronic diaries), patient enrollment, site monitoring, review of monitor visit reports and review of status in CRO CTMS.
Training and oversight of other QCO representatives including contract/third party QCO representatives.
Participate in CRO trainings and investigator meetings
Review CRO CRA and contract/third party QCO representative CVs.
Point of contact for CRO for QCO activities and provide guidance on issue resolution.
Participate in study team teleconferences with CRO as necessary, present findings from QCO visits and monitoring report review
Liaise with CTM and CRO to create action plans based on QCO findings to improve monitoring quality.
Coordination of monitoring report review and QCO visits in collaboration with the Global/Regional CTM.
Perform QCO of CRO Monitor Visit Reports; enter any findings on the QCO Issues/Resolution Log and follow to resolution.
Review QC visit reports conducted by contract/third party QCO representatives for assigned regions.
Ensure all issues identified by QCO representatives are entered on the QCO Issues/Resolution Log and sent at prescribed intervals to the internal Shionogi and CRO study team.
Conduct QCO visits at investigative sites, identify and follow-up on site action items, prepare QCO visit report.
Interface with investigators, study coordinators, and study personnel via telephone, written correspondence, and on-site visits.
Participate in targeted QC of Trial Master File.
As needed perform CRA Monitoring Responsibilities for Shionogi clinical studies:
Interface with investigators, study coordinators, and study personnel via telephone, written correspondence and on-site visits.
Coordinate and disseminate information to site staff (i.e., study protocol, CRFs)
Monitor study protocol(s). Collect and review regulatory documents and perform source document verification.
Provide verbal reporting of any serious adverse events related to the study project.
Complete QC trip reports and other required forms. Provide documentation for related correspondence.
Bachelors degree in a relevant field; R.N. or equivalent. At least 10 years minimum experience
in clinical research monitoring, preferably including knowledge of multiple therapeutic areas of
relevance to assigned projects.
A minimum of 7 years of progressively responsible clinical trial experience within a
pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
Analytical, negotiation, meeting management, cross-functional team, and leadership skills
required as demonstrated from representation at a management level.
Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and a
willingness to teach others as evidenced by a collaborative work style.
Knowledge of Word, Excel, PowerPoint and Microsoft Office.
Demonstrates core understanding of medical terminology and clinical trial activities in relation
to execution of a clinical development plan.
Strong working knowledge of Good Clinical Practices (GCPs) and pertinent U.S. FDA Code of Federal Regulations.
Demonstrated ability to attend to detail, make effective presentations and work independently.
Ability to travel independently by air, car and/or train.
Willingness and ability to spend prolonged periods of time reviewing medical charts and data
collection forms and utilizing a small screen laptop computer.
Willingness and ability to travel up to 50% of the time to investigative sites throughout the
United States and occasionally internationally.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilitiesmay change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity