Title: Clinical Trials Research Assistant, Associate and Specialist positions Location: Iowa City IA United States Job Description: The Department of Biostatistics Clinical Trial Statistical Data Management Center is seeking Clinical Trials & Data Management Research Assistant, Associate and Specialist positions, remote and hybrid work available. Responsibilities include assisting in the development of data management plans and identifying appropriate resources for research projects; assisting with designing forms to collect and track study data, subjects, drugs, biological specimens and/or procedures; assisting in the design of database management system applications and developing specifications for data collection and modules; assisting with data processing tasks including data cleaning, reconciliation, and reporting. This position will work closely with external research partners and other CTSDMC team members to determine requirements and create comprehensive solutions for data collection, verification and validation. As a member of the CTSDMC Data Management team, this position will work closely with the IT and Protocol Coordination teams to develop the databases and data entry systems. This position is responsible for mission-critical research applications and sensitive data, so attention to detail and quality are critical. Benefits Highlights: This is a regular, salaried position. Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans. Complete information regarding the full benefits package may be viewed at: Benefits | University Human Resources - The University of Iowa (uiowa.edu) Application Details: To be considered for an interview, applicants must upload a resume and cover letter and mark them as a "Relevant File" to the submission. Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to five professional references will be requested at a later step in the recruitment process. This position is eligible for remote or hybrid work within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location. Additional Information: Classification Title: Clinical Trials & Data Management Research Assistant, Associate and Specialist Appointment Type: Professional and Scientific Schedule: 100% positions available Work Modality Options: on-campus/Hybrid/remote within Iowa negotiable Pay Level: Research Assistant 3A Research Associate 4A Research Specialist 5A Contact Information: Organization: College of Public Health Contact Name: Kay Shie Contact Email: Research Assistant: Required: - Requires the academic knowledge of a discipline plus the ability to translate, adapt and apply this knowledge that is generally associated with a Bachelor's degree or an equivalent combination of education and experience - Excellent written and verbal communication skills and attention to detail - Strong interpersonal and organization skills - Ability to apply critical thinking, technical problem solving, and analyzing system specifications - Occasional out-of-state travel - Knowledge and considerable experience with Microsoft Office Suite or similar software Highly Desirable: - Knowledge and some experience (1 year) with database programming (e.g. SQL), or relational database systems or statistical packages (SAS or R). Desirable: - Knowledge of and/or experience with Azure DevOps for development tracking - Knowledge of 21 CFR Part 11 compliance - Knowledge of GCP and ICH guidelines - Research Associate: Required: - Requires the academic knowledge of a scientific field including advanced study or demonstrated capacity for scientific research that is generally associated with a Bachelor's degree, supplemented by one or more years of progressively responsible experience in the data management field including data collection tool development and/or data cleaning or an equivalent combination of education and experience - Excellent written and verbal communication skills and attention to detail - Strong interpersonal and organizational skills - Ability to apply critical thinking, technical problem solving, and analyzing system specifications - Occasional out-of-state travel - Knowledge and considerable experience with Microsoft Office Suite or similar software Highly Desirable: - Knowledge and some experience (2-3 years) with database programming (e.g. SQL), or relational database systems or statistical packages (SAS or R). Desirable: - Knowledge and/or experience with Azure DevOps for development tracking. - Familiarity with research processes - Experience in design and development of database system and developing specifications for applications - Experience with group presentations - Knowledge of 21 CFR Part 11 compliance - Knowledge of GCP and ICH guidelines Research Specialist: Required: - Requires the academic knowledge of a scientific field, including advanced study or demonstrated capacity for scientific research, that is generally associated with a Master's degree, supplemented by three or more years of progressively responsible experience in the data management field including data collection tool development and/or data cleaning, or an equivalent combination of education and experience - Excellent written and verbal communication skills and attention to detail - Strong interpersonal and organizational skills - Ability to apply critical thinking, technical problem solving, and analyzing system specifications - Occasional out-of-state travel - Knowledge and considerable experience with Microsoft Office Suite or similar software Highly Desirable: - Knowledge and experience (4-5 years) with database programming (e.g. SQL), or relational database systems or statistical packages (SAS or R). - Experience with Microsoft PowerBI for data visualization Desirable: - Knowledge of and/or experience with Azure DevOps for development tracking - Experience conducting clinical or social science research - Experience in design and development of database system and developing specifications for applications - Experience with group presentations - Knowledge of 21 CFR Part 11 compliance - Knowledge of GCP and ICH guidelines Additional Information - Classification Title: Clin Trials Rsrch Specialist - Appointment Type: Professional and Scientific - Schedule: Full-time - Work Modality Options: On Campus, Hybrid within Iowa, Remote within Iowa Compensation - Pay Level: 5A Contact Information - Organization: College of Public Health - Contact Name: Kay Shie - Contact Email:

Role Description Are you a BCBA ready to lead, mentor, and make a meaningful impact beyond traditional therapy settings? We’re seeking a Clinical Supervisor to provide oversight and guidance within our Respite Services Program, supporting children and young adults in home and community environments. Qualifications - Active BCBA certification (in good standing) - Master’s degree in ABA, Psychology, Education, or related field - 1+ year clinical experience - 1+ year supervising staff - Strong leadership & communication skills - Reliable transportation - Bilingual preferred Requirements - Provide clinical oversight for respite clients - Develop and monitor behavior support plans as needed - Coach and mentor Direct Support Professionals (DSPs) - Partner with families to promote safety and independence - Ensure service delivery, documentation compliance & quality standards - Support crisis prevention and real-time behavior guidance Benefits - Competitive compensation: $80,000K – $90,000K per year - Student loan repayment assistance/refinancing – Receive $3,000 annually through GRADIFI and consolidate loans at a competitive rate - Monthly bonus opportunities - In-house CEU events plus $1,000 CEU reimbursement - Health benefits: Medical, Dental, and Vision (company covers 100% of dental and vision, 90% of medical) - Career development and advancement opportunities - Generous time off (DTO) and flexible scheduling - Great and fun company culture - 401(K) retirement savings program - Mileage and phone reimbursement - And so much more!

Role Description The Clinical Team Lead will provide operational support to managers and supervisors for the assigned program. The Team lead is an individual contributor. Team lead assignments will be highly dependent on operational needs and priorities. The team leader will work closely with leaders to use data and reporting to identify and prioritize supports needed. They will act as subject matter experts for system and program support. You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. Prefers Southern California, but candidates could live outside of California if they have a good candidate. Primary Responsibilities: - Onboarding new teammates, provide training for the assigned work and monitor quality of work performance during the probationary period. - In collaboration with the management team will provide ongoing training to teammates identified through quality auditing where opportunities are identified to improve performance or productivity. - In collaboration with the management will develop and provide training to teams for all new, updated processes and workflows. Training attendance will be documented and submitted with the Operational Support team. - Manage patient and provider escalations or grievances by providing research into the inquiry and provide a summary to the leadership for actions needed. - Manage health plan escalations in collaboration with the delegation oversight team. - Development and maintenance of all job aids that support system and processes for the assigned team. - Support for organizational realignment and change management by providing training, document updates and communication. - Support resource planning and allocation by reviewing daily assignments, shifting resource assignments when necessary to manage daily workloads. - Teammate scheduling when applicable. - Internal messaging and communication on upcoming changes and plans for operational readiness related to membership, programs, regulations or health plan changes. - Technology training and change readiness monitoring in support of system modifications. - Post implementation program/process monitoring and re-training to assure quality and performance meet team goals. - Implementation and monitoring of process changes needed to support CAP remediation in close collaboration with the Delegation oversight team. - Works with teams to bring forward patients for IDT collaboration. - Monitors team caseloads and productivity and make recommendations to leadership for workforce management. Qualifications - Unrestricted RN license. - California license. - 3+ years of broad-based clinical experience and an expert in their respected function. Requirements - Demonstrate knowledge of PC applications including MS Office Suite. - Ability to use written and oral communication skills. - Ability to read and interpret data. - Skill in writing clear, grammatically correct, easy–to-use instructional documentation. - Ability to identify learning needs, set goals and seek educational opportunities. - Ability to analyze problems and formulate appropriate plans, solutions and courses of action. - Knowledge of age specific communication is needed with the ability to listen actively and respond to internal and external customers in a timely, competent manner both verbally and nonverbally. - Ability to work with frequent interruptions. - Ability to establish and maintain cooperative working relationships with individuals at all levels of the organization and affiliates. - Ability to maintain confidentiality of patient and all related entity business matters of the organization and its partners. - Ability to manage detail and work with accuracy. - Ability to recognize and act appropriately in situations where patient care needs exceed medical certification. - Skill in working with a team; ability to collaborate on projects with colleagues. - Skill in working effectively under deadlines and changing priorities. Benefits - Comprehensive benefits package. - Incentive and recognition programs. - Equity stock purchase. - 401k contribution (all benefits are subject to eligibility requirements). - Salary range from $72,800 to $130,000 annually based on full-time employment. Application Deadline This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

Title: Clinical Trial Coordinator - FSP - Sweden Location: Stockholm Sweden Full time Remote Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate. • Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. • Provides system support (i.e. GoBalto & eTMF). • Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. • Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. • Reviews and tracks local regulatory documents. • Transmits documents to client and centralized IRB/IEC. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Maintains vendor trackers. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • May attend Kick off meeting and take notes when required. Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required • Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude with effective strong interpersonal skills