• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment • Develop and finalize the country recruitment/retention strategy • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs • Address all CRA and site questions and maintains FAQ log • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies for assuring study timelines are met • Generate and utilize metric reporting to ensure that the study is conducted per plan • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues when necessary • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines • Manage processes for investigational product (IP) including drug accountability and reconciliation • Supports business development and marketing activities as appropriate

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work • Ensure that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study • Generate potential site list...

Role Description Premier Research is looking for a Clinical Lead II (Oncology) to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing: - Serves as initial point of contact for all site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP). - Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables. - Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools. Strong contributor to the central monitoring plan. - Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines. - Ensures a state of audit readiness for both Premier and sites. Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings. - Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires prompt assessment and reporting. Qualifications - Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience. - 2 years of experience as a Clinical Lead. Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred. - Required Therapeutic Area: Oncology. - Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to achieve targets. - Working knowledge of clinical financials including understanding of budgets, pass-through and resource management. - Ability to multitask and work effectively in a fast-paced environment with changing priorities. Requirements - Minimum base pay for this role is $116,000.00 USD. - Actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Benefits - Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off. Company Description Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description The Clinical Placement Coordinator in the Office of Field Experience (OFE) works with MSN Family Nurse Practitioner students to support the students' required clinical field experiences (externships). The Clinical Placement Coordinator is dedicated to supporting students by developing and implementing plans for clinical placements by: - Reviewing program and student clinical site requests - Facilitating document collection and approvals - Identifying available site mentors/preceptors The Clinical Placement Coordinator proactively communicates with students to ensure understanding and timely completion of required documentation and approvals, and assists students throughout their program to keep the requirements and approvals current. Essential Duties and Responsibilities: - Responsible for managing and tracking overall student clinical experience compliance. - Counsels students on expectations, requirements and guides students to appropriate resources. - Work proactively with students to ensure all necessary health and safety documentation is uploaded and approved in required systems. - Proactively partner with students to determine and identify best placement options. - Responsible for outreach and development of clinical sites and mentors/preceptors which have been identified by student, College, market research or administration. - Manage and track the Affiliation Agreement legal review with Affiliate Coordinator and the legal departments of the site. - Monitor and ensure all site mentors/preceptors have submitted required documents and have access to required systems. - Work collaboratively with other OFE staff and management as well as College leadership. - Handle a high volume of incoming and outgoing phone calls and emails from students and site contacts while maintaining consistent notes, history, and documentation in required systems. - Provides administrative support by improving and implementing systems, procedures, and policies; completing projects in support of OFE efforts. - Other duties/responsibilities as assigned. Qualifications - Education Administration, 1 + years (preferred) - Healthcare Administration, 1 + years (preferred) - Business Development, 1 + years (preferred) - Any equivalent combination of experience and/or education from which comparable knowledge, skills & abilities have been achieved. - Bachelors (preferred), in business, management, health administration, or related field. Some college education is required. Requirements - This job is remote. Employees must have a designated, private, quiet workspace when working remotely. - Remote employees are expected to be on camera for meetings and training sessions. - Employees are responsible for abiding by all FERPA privacy laws within their home-work environment and while in office. - All work must be completed during standard workweek hours; employees are not permitted to work evenings or weekends as a standard schedule. - The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. - This position may involve working in a combination of environments and may require travel. - While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. - Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. - The work environment and physical demands described are representative of those required of an employee to perform the essential functions of this job with or without reasonable accommodations. Benefits - At Aspen Group, we embrace diversity, we support it, we celebrate it and we thrive on it for the benefit of our employees and our community. - We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. - Aspen Group is proud to be an equal employment opportunity employer. Company Description Aspen Group, Inc is an education technology holding company that leverages its infrastructure and expertise to allow its two universities, Aspen University and United States University, to deliver on the vision of making college accessible and affordable.