Department: 85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: 8 AM - 4:30 PM, Monday through Friday. Remote position. Pay Range $30.70 - $46.05 Major Responsibilities: - Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies. - Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human Resource Protections (OHRP), and other regulatory bodies, including central offices of cooperative group studies, and sponsors where necessary. Supports submissions to ancillary committees. - Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions and ensure timely review and approval in compliance with local and external IRB SOPs and other regulatory agency requirements. - Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout. - Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management. - Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events. - Maintains study level documentation for all studies, including those that are complex in nature. Ensure files are audit ready. Monitors compliance required documentation. - Enters and maintains study information and regulatory approvals in electronic systems. - Provides guidance and training to research staff to ensure compliance with highly complex, highly specialized regulations and guidance associated with clinical research studies and trials involving human subjects. Attends and participates in educational programs, meetings and assigned committees. - Participates in the development and implementation of quality improvement and quality assurance activities. Other duties as assigned. Licensure, Registration, and/or Certification Required: - None Required. Education Required: - Bachelor's Degree (or equivalent knowledge) in Business or related field. - Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field. Experience Required: - Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge. Knowledge, Skills & Abilities Required: - Knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents. - Knowledge of policies, procedures and SOPs specifically related to regulatory documents. - Knowledge of clinical trials and terminology required. - Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree to accuracy and attention to detail. - Good understanding of computer software, Microsoft Office, Word, Excel, Adobe, and Teams - Ability to travel between facilities as needed. Physical Requirements and Working Conditions: - Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently during the work shift. - Must have functional sight and hearing. - Exposed to a normal office environment. - Position may require travel. May be exposed to road and weather hazards. This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties. Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including: Compensation - Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training - Premium pay such as shift, on call, and more based on a teammate's job - Incentive pay for select positions - Opportunity for annual increases based on performance Benefits and more - Paid Time Off programs - Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability - Flexible Spending Accounts for eligible health care and dependent care expenses - Family benefits such as adoption assistance and paid parental leave - Defined contribution retirement plans with employer match and other financial wellness programs - Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

• Accountable for global study delivery within agreed timelines and budget • Leads all aspects of assigned clinical study(ies) • Leads global cross-functional study team including oversight of external partners • Collaborates with stakeholders and provides regular updates on study progress to senior management • Ensures alignment of study goals with clinical operations and corporate goals • Monitors study activities to ensure compliance with the study protocol and regulations • Manages study budgets and resources effectively

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. The preferred candidate holds 1-3 years of clinical monitoring experience and must have experience in one of these therapeutic areas: Oncology, Respiratory (COPD/Nasal Polyps) Gen Med, or Vaccines. Travel is required for this role, including overnight stays. Essential Functions and Other Job Information: Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Qualifications: Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ year as a clinical research monitor) Valid driver's license where applicable. 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. Working Conditions and Environment: Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions. Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Compensation and Benefits The salary range estimated for this position based in Illinois is $66,800.00–$122,400.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Must be Epic Cupid certified Must have extensive build experience in either invasive or non invasive Description Summary Our client has an immediate and urgent need for two Epic Cupid Analysts. These roles are in support of the acquisitions our client has made across the state. Scope of Work: Build Epic workflows for CPACS integration Required Skills: Epic Cupid Certification CPACS Integration experience EHR implementation experience Preferred Skills: Change Healthcare PACS experience Philips ISCV and XPER experience Skills Epic, Epic certified, Build, Cupid Top Skills Details Epic, Epic certified, Build, Cupid inpatient Job Type & Location This is a Contract position based out of Dallas, TX. Pay and BenefitsThe pay range for this position is $70.00 - $100.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace TypeThis is a fully remote position. Application DeadlineThis position is anticipated to close on Mar 16, 2026. h4>About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems and TEKsystems Global Services We’re a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We’re a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We’re strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We’re building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.