Business Operations Specialist II

Essential Job Duties:o Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenanceo Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelineso Serve as primary contact for investigative sites and ensure documents required are collected in a timely mannero With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirementso May support / assist the contract negotiation process under supervision of an experienced colleague or line managero Escalate study issues appropriately and in a timely fashiono Update study documents when there are changes in study personnel/study amendmentso Contribute to the preparation of submissions to IRB/IEC with appropriate supervisiono Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any timeo Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervisiono Perform other duties as assigned by managementEducation/Qualifications/Certifications and LicensesRecommended:o Level of education preferred (if required or experience level which may be substituted for level of education).o Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).o University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)o ExperienceMinimum Required:o Minimum 0 – 2 + years of experience, or an equivalent combination of education andexperience to successfully perform the key responsibilities of the jobo Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.o Demonstrated basic understanding of the clinical trial processLabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement. Job SummaryJob number: 2311770Date posted : 2023-02-23Profession: ClinicalEmployment type: Full-Time