Job Details Senior Regulatory Research Coordinator (Sidney Kimmel Cancer Center - Remote Position) Job Description Job Summary: The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Trials Office (CTO) is seeking a Senior Regulatory Research Coordinator dedicated to supporting a complex portfolio of investigator-initiated trials. The Senior Regulatory Research Coordinator works under limited supervision and is responsible for the accurate compilation and submission of protocols and related study documents to various internal and external approving committees. These may include the Protocol Review and Monitoring Committee (PRMC), IBC, Radiation Safety, FDA and/or NIH, and the applicable Institutional Review Board (IRB). The Senior Regulatory Research Coordinator is responsible for maintaining electronic regulatory study files to ensure all protocols and essential regulatory documents are current and complete. Primary Responsibilities: Serves as the primary regulatory contact for assigned protocols. - Maintains the electronic regulatory binders / files and ensures appropriate version control is in place. - Coordinates submissions to ancillary committees such as Radiation Safety and Institutional Biosafety. - Communicates with the IRB and sponsor on behalf of the study team regarding regulatory management. - Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations. - Prepares and submits study amendments and continuing review applications for PRMC and IRB review. - Prepares regulatory files for auditing and monitoring visits. - Communicating to study teams the importance of adhering to CTO Regulatory processes - Other duties as assigned Qualifications: The ideal candidate will have a HS diploma with 6 years clinical research experience and SOCRA Certification, or a Bachelor’s degree in a scientific or healthcare-related field with at least 2 years clinical research experience, or a Master’s degree in a scientific or healthcare-related field with 1 year clinical research experience. Additional qualifications include: - Strong written and oral communication skills, attention to detail, customer service orientation, and proven ability to perform work accurately and efficiently. - Experience working with grant funded and Investigator-Initiated clinical trials. - Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials. - Familiarity with terminology and processes associated with the conduct of clinical research. - Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov. - Demonstrated ability to work independently and with a team. - Demonstrated proficiency with Microsoft Office, including Outlook, Teams, OneNote, Word, and Excel. Work Shift Rotating (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson UniversityPrimary Location Address 1025 Walnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa­tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Clinical Trial Assistant provides the Clinical Operations Team members with administrative and project-specific support related to the conduct of clinical trials. This includes assisting with study team activities and performing administrative clerical duties. The Clinical Trial Assistant is also responsible for obtaining study materials and tracking of invoices and clinical study trackers. Essential Functions and Responsibilities - Adhere to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines. - Assist in contacting investigator sites to provide study specific information. - Ensure receipt, completeness and accuracy of clinical and administrative documents. - Coordinate distribution and shipment of study-related materials. - Coordinate investigator site/payment as needed. - Maintain telephone contact with sites, contract research organization personnel, vendors and CRAs as needed. - Facilitate flow and maintenance of correspondence with sites. - Attend clinical project team meetings and takes minutes. - Contract, invoice and budget management and tracking. - Assist in coordination of study initiation documentation materials. - Responsible for compiling/QC checking/generating copies of clinical documents that are intended for submissions including 1572s (original and updated), Informed Consent Form, Protocol and Investigator’s Brochure. - Coordinate distribution of study team materials and meeting minutes. - Draft and prepare documents for mass mailings (e.g., protocol amendments). - Assist with preparation of presentation materials. - Maintain central registry of contact information for clinical sites, contract research organizations, vendors and CRAs. - Set up teleconference calls with sites and team and record minutes. - Maintain central monitoring calendar for all site visits. - Create and maintain Central Clinical files. - Perform administrative and clerical duties. - Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. - Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge - 2 + years of pharmaceutical or biotech-related/clinical research, oncology or research experience. - Excellent verbal and written communication skills. - Attention to detail. - Demonstrated ability to work independently and exhibit initiative. - Computer literacy required (MS word, MS Excel, MS PowerPoint and MS Project) Preferred Education, Skills, and Knowledge - Bachelor’s Degree or Equivalent in a scientific or health care discipline preferred. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required - Must be able to remain in a stationary position standing or sitting for prolonged periods of time. - Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. - Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. - This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. - Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines Work Environment This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. #LI-remote The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

Company Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring a Participant Recruitment Manager at Wake Research, an M3 company. This is a remote role. Job Description The Participant Recruitment Manager leads and supports a team of Participant Recruitment Specialists across multiple U.S. research sites, ensuring a consistent and effective approach to study recruitment. This role partners closely with Marketing and Clinical Operations to align recruitment strategy, protocol requirements, and site capacity to achieve predictable, high-quality enrollment outcomes. The position translates recruitment demand into structured operational execution and measurable results. Success in this role requires strong people leadership, operational rigor, and data-driven decision-making. Essential Duties and Responsibilities: - Provide leadership and direct supervision to a distributed team of Participant Recruitment Specialists across multiple research sites. - Drive recruitment and enrollment performance by establishing clear expectations, accountability standards, and measurable outcomes. - Partner closely with Marketing and Clinical Operations to align recruitment strategy with real-time site capacity and study timelines. - Interpret and operationalize clinical study protocols, including inclusion/exclusion criteria and visit schedules, into effective screening workflows. - Develop, maintain, and ensure compliance of patient screeners, qualification scripts, and enrollment processes. - Monitor individual and team performance through KPIs, dashboards, and reporting to support data-driven decision-making. - Identify operational bottlenecks, conversion challenges, and workflow gaps, implementing corrective action plans to improve efficiency. - Provide regular enrollment forecasts, performance updates, and strategic insights to senior leadership while staying current on best practices in patient recruitment and retention. Qualifications - 5-7+ years of experience in clinical research, including at least 3 years in a management role - Experience working with CTMS platforms Clinical Conductor/Realtime, Dialpad recruitment tracking systems, and performance dashboards - Demonstrated success driving participant recruitment and enrollment performance across multiple studies or sites - Strong understanding of clinical trial processes and inclusion/exclusion interpretation - Excellent leadership, coaching, and performance management skills - Strong analytical skills with the ability to translate data into actional operational improvements - Clear and effective communication across cross-functional teams - Ability to operate effectively in a fast-paced, metrics-driven environment requiring collaboration across multiple departments and studies. - Proven ability to establish and manage KPIs tied to conversion rates, show rates, and enrollment outcomes Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: - 401(k), 401(k) matching - Dental insurance - Disability insurance - Employee assistance program - Flexible spending account - Health insurance - Life insurance - Paid time off - Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

Clinical Site Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Clinical Site Associate (CSA) Open to candidates located anywhere in the USA. ICON is currently seeking a Clinical Site Associate (CSA) to join our diverse and dynamic team. We are looking for candidates with a minimum of one year of experience as a Study Coordinator in clinical research. In this role, you will play a pivotal part in supporting clinical trial operations by ensuring site compliance, maintaining accurate documentation, and supporting audit and inspection readiness. The position involves close collaboration with Clinical Research Associates and cross-functional teams to ensure efficient and high-quality trial execution. . What you will be doing Site Support & Oversight: - Manage site-level communications - Coordinate site trainings and systems access - Support site readiness activities including pre/post site visit tasks - Follow-up on action items Document Management: - Maintain Trial Master File (TMF) Your profile - Candidates must have completed a Bachelor’s degree in a relevant field, such as Life Sciences or Healthcare. - Previous experience in clinical research or a related field preferred - Strong organizational and communication skills - Ability to work independently and collaboratively in a fast-paced environment - Attention to detail and ability to prioritize tasks effectively What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply