IRT Business Associate This is a Remote Role Duration: 12 Months - Possible extension if good performance and needs of the business are both there. Work Schedule: Mon - Fri, Business Hours ** Preferred Candidate be on East Coast to work East Coast Hours** Please list candidate's current resident City and State underneath their name on the resume
Position Summary: Manages IRT for multiple studies (system development, vendor oversight, change management, data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives.
Responsibilities: • Lead successful execution and on time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to client standards and quality principles.? • Lead IRT projects as a strategic partner and single point of accountability to partner lines for IRT protocol assessments, requirements elicitation, system deployments, and resupply. • Work independently and assume decision making responsibilities on assigned projects. Collaborate with the IRT Leadership Team where necessary to ensure client standards and/or for requests by study teams that are not within these standards or best practice are addressed. • Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. • Maintain vendor performance quality events in ADI log. • Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency. • Support key department and enterprise level initiatives as the IRT representative. • Responsible for generation an oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply Operations and IRT vendors. • Participate in IRT vendor relationships and oversight to ensure delivery of IRT systems and seamless services; as well as, foster a collaborative relationship. • Consult and ensure on time delivery of user acceptance testing of IRT systems consistent with client SOPs and procedures. This includes fostering collaboration and best practices with the IT QA organization. • Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance client SOPs and processes. • Ensure effective system access and functionality across all countries and all user locations • Ensure on time development of IRT data transfers with vendors and/or third-party vendors. • During IRT Maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved. • Support all unblinding activities. • Ensure eTMF compliance at the study level in accordance with group and client guidance. • Engage and support study and CSMT project teams as deemed necessary. • Ensure delivery of data to client departments and third-party vendors consistent with client SOPs and forms. Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of client goals.
Education Required: • Bachelor's Degree
Experience Required: • Minimum of 1 year work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) . • Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint • Clinical Research experience • Working knowledge of IRT • Working knowledge of Clinical Trial Management Systems • Working knowledge of clinical supplies • Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio • Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards • Exposure to working in a GMP / GCP environment and with regulatory audit teams • Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required • Comfortable working with a global team, partners and customers in a change agile environment MS Project, MS Visio, or any other requirements visualization and analysis tools)Position is offered by a no fee agency. Location : 0000, no name, Other, United States, 00000 About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.
