CenExel

Role Description The Clinical Trial Assistant (CTA) supports the planning, coordination, and execution of clinical research studies. This role ensures that clinical trials are conducted in compliance with regulatory requirements, study protocols, and internal procedures. The CTA works closely with clinical research associates (CRAs), study managers, investigators, and sponsors to maintain accurate documentation and facilitate smooth trial operations. Essential Responsibilities and Duties - Assists in the preparation, collection, and maintenance of clinical trial documentation (e.g., Trial Master File (TMF), Investigator Site Files (ISF)). - Tracks and manages study-related documents, ensuring completeness and compliance with regulatory standards (e.g., FDA, ICH-GCP). - Supports study start-up activities, including site selection, regulatory submissions, and ethics committee documentation. - Coordinates communication between study teams, sponsors, and investigational sites. - Maintains study tracking tools, including timelines, enrollment status, and site performance metrics. - Assists with scheduling meetings, preparing agendas, and documenting meeting minutes. - Supports monitoring visit logistics and follow-up actions. - Ensures proper filing, archiving, and version control of study documents. - Assists in safety reporting and tracking adverse events, as required. - Assists with financial tracking, including invoice review and matching against Clinical Trial Agreement, budgets and visit schedules / milestones. - Provides administrative support to the clinical operations team. - Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working practices, protocol, and company guidelines and policies. - Assumes other duties and responsibilities as assigned. Qualifications - Bachelor’s degree in life sciences, healthcare, or a related field (preferred). - 1–2 years of experience in clinical research. - Knowledge of clinical research processes and regulations (e.g., ICH-GCP guidelines). - Working knowledge of CTMS (e.g. Clinical Conductor or similar). - Working knowledge of e-TMF or e-ISF systems (e.g. Florence or Veeva Vault). - Strong organizational and time management skills. - Attention to detail and accuracy in documentation. - Effective written and verbal communication skills. - Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint). - Ability to manage multiple tasks and meet deadlines. - Must be able to effectively communicate verbally and in writing. Requirements - Essential physical requirements include sitting, typing, standing, and walking. - Lightly active position, occasional lifting of up to 20 pounds. - Reporting to work, as scheduled, is essential. - Remote work arrangement. Compensation $22.25 - $26.97/h depending on education, experience, and skillset. Company Description CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

• Owns paid media strategy and execution across key channels including Meta, Google Ads, YouTube, Reddit, and programmatic platforms (DSPs), with full accountability for performance and ROI. • Proactively recommends channel mix, budget allocation, and spend levels based on study demand, historical performance, and enrollment targets. • Continuously analyzes campaign performance (CPL, conversion rates, randomization yield) and optimize in real time to improve efficiency and outcomes. • Aligns marketing strategy to study-level recruitment needs, identifying trials at risk of under-enrollment and deploying targeted advertising interventions. • Partners closely with site teams and recruitment operations to develop, test, and implement tailored recruitment plans for priority studies. • Leads the end-to-end patient acquisition funnel, including ad creative, landing pages, prescreeners, and follow-up workflows to maximize conversion and enrollment. • Leverages AI tools and data-driven insights to enhance targeting, creative development, and funnel performance. • Develops scalable playbooks and best practices for patient recruitment across indications and channels. • Mentors and supports junior marketing team members, providing guidance on campaign strategy, execution, and performance analysis. • Supports broader marketing initiatives including website updates, collateral development, and community outreach as needed. • Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. • Assumes other duties and responsibilities as assigned.

• Leads CenExel’s sponsor services model. • Partners with CROs and sponsors to execute defined services post-award. • Develops the full proposal package. • Coordinates internal resources, identifies and engages vendors. • Aligns with CRO partners to ensure comprehensive, competitive submission and bid defense. • Drives consistent execution from startup through closeout. • Builds and implements KPIs tied to SRD scope, timelines, quality, and financial performance.

Role Description The Clinical Research CV and Credentials Coordinator is responsible for curriculum vitae (CV) creation for all CenExel Site Staff (including contracted staff) and onboarding new Investigators. This role ensures compliance with institutional, regulatory, and sponsor requirements, supporting clinical trials and research operations. - Collects, creates, and maintains CVs for investigators and research staff. - Collects and reviews credentialing documents (licenses, certifications, GCP training, etc.) for investigators and research staff. - Ensures CVs are current (biennially for research staff and biannually for principal investigators) and formatted appropriately for regulatory submissions. - Verifies professional licenses and certifications with appropriate boards and agencies. - Tracks credentialing expiration dates and sends timely reminders for renewal. - Maintains electronic databases or regulatory systems (e.g., CTMS, eReg) to manage documents and track compliance. - Collaborates with clinical research coordinators, investigators, and regulatory specialists to ensure documentation completeness and accuracy. - Assists with audit preparation and responds to documentation-related requests from sponsors, CROs, or regulatory authorities. - Ensures all documentation meets FDA, ICH-GCP, and sponsor requirements. - Supports onboarding of new research personnel by gathering initial credentials and ensuring training compliance. - Regularly reviews and updates site-specific trial lists to include newly awarded studies. - Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working practices, protocol, and company guidelines and policies. - Assumes other duties and responsibilities as assigned. Qualifications - Must be able to effectively communicate verbally and in writing. - Bachelor’s degree in Health Sciences, Life Sciences, Healthcare Administration, or related field preferred. - 1–3 years of experience in clinical research, credentialing, or regulatory documentation. - Familiarity with ICH-GCP, FDA, and other regulatory guidelines. - Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and document management systems. - Strong attention to detail and organizational skills. - Ability to handle confidential information with discretion. - Excellent communication and interpersonal skills. - Experience with electronic regulatory systems (e.g., RealTime, Florence eBinders). - Certified Clinical Research Professional (CCRP) or equivalent credential is a plus. Requirements - Essential physical requirements include sitting, typing, standing, and walking. - Lightly active position, occasional lifting of up to 20 pounds. - Reporting to work, as scheduled, is essential. - Remote work arrangement. Benefits - Highly competitive compensation. - Generous benefits package to full-time employees after 30 days of employment including: - Health Insurance - Dental - Vision - LTD - STD - Life Insurance - 401k Company Description CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials.

About Us: CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: The Site Optimization Specialist supports site leadership and corporate teams to ensure efficient start-up and delivery of multi-site clinical trials. This role acts as a liaison between site operations, business development, and other departments to facilitate communication and resolve requests. Essential Responsibilities and Duties: - Promotes CenExel's image and clinical trial conduct service capabilities in a way which will further the company's objectives, growth, and profitability. - Supports the use of corporate technology across sites. - Provides processes and support to ensure a seamless, quick start-up process and actively manages study start up as the processes are developed, implemented, and improved. - Collaborates with all stakeholders including sponsors/CROs, site personnel, and site leadership to foster communication, collaboration, and a unified trial team, ensuring efficient delivery. - Works closely with and responds to Site Operations and Business Development on client management and communication regarding ongong multi-site studies. - Proactively works to meet expected enrollment numbers, marketing, and recruitment performance and provides metrics as requested. - Conducts in-depth reviews of protocol design, competing trials, and recruitment benchmarks. - Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. - Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: - Bachelor's degree or equivalent experience in health sciences, business, project management, or related field. - Experience in clinical research (Coordinator, Assistant, or Project Manager roles). - Familiarity with CTMS, EDC, and site operations. - Strong communication and analytical skills. - Collaborative skill set to enable strong working relationship with site and corporate leadership in overseeing study launch and delivery. - Sufficient experience in progressively responsible project management roles. - Understanding of site operations. - Ability to distill key information from clinical protocols. - Solid technical understanding. - Excellent communication skills with internal and external stakeholders. - Ability to travel 5%. Working Conditions - Indoor, Office environment. - Essential physical requirements include sitting, typing, standing, and walking. - Lightly active position, occasional lifting of up to 20 pounds. - Reporting to work, as scheduled, is essential. - Remote work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job Summary: This position is responsible for interfacing with site users to ensure accurate and timely data entry of study subjects identifiers into the CTSd (Clinical Trial Subjects database.) The hourly range is subject to location. The average range is from $26.00 - $32.00 REMOTE POSITION Essential Responsibilities and Duties: - Familiarity with CTSd (Clinical Trial Subjects database) purpose and function. - Implements and monitors database access and configurations. - Troubleshoots and resolves basic computer, application, system, device, access, or performance issues. - Troubleshoots basic database issues, resolves user entry problems and database performance. - Advises users on the methods, steps, and actions to resolve and avoid future issues and provides documentation as needed. - Performs pre-production testing as required prior to release of CTSd software enhancements. - Assures stability of CTSd support systems, including internet, phone, fax and supplies. - Escalates customer complaints to COO or President, if necessary. - Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: - Must be able to effectively communicate verbally and in writing. - Bachelor's Degree, preferred. - 1+ year of experience in clinical research required - Working knowledge of Microsoft Office Suite, including PowerBI and Teams, preferred. Working Conditions - Indoor, Office environment. - Essential physical requirements include sitting, typing, standing, and walking. - Lightly active position, occasional lifting of up to 20 pounds. - Reporting to work, as scheduled, is essential. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Title: Registered Dietitian - Clinical Research (Part-Time) Location: Anaheim, California, 92801, United States Department: Dietary Job Description: About Us: Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Hourly Range: $31.00/hr - $35.00/hr (depending on education, experience, and skillset) Schedule: Monday - Friday - 20hrs a week - 08:00 am -12:00 pm Job Summary: The Registered Dietitian (RD) supports the multi-site clinical research network by providing expert nutrition oversight for research protocols involving dietary interventions, metabolic assessments, or nutrition-related endpoints. The RD collaborates with investigators, coordinators, and operational teams to ensure nutritional components of studies are implemented accurately, consistently, and in compliance with protocol requirements, regulatory standards, and ethical guidelines. Essential Responsibilities and Duties: - Reviews research protocols to identify and interpret all nutrition-related requirements, including dietary interventions, nutritional assessments, biospecimen collection related to nutrition, and meal-controlled feeding. - Develops standardized nutrition procedures, documentation, and tools to ensure consistency across network sites. - Supports feasibility assessments by evaluating site capabilities for nutrition-related activities (e.g., metabolic kitchen, specialized diets, equipment). - Conducts nutrition screening, assessments, and counseling for study participants per protocol guidelines. - Develops individualized or protocol-specific meal plans (including controlled diets, macronutrient-specific diets, allergen-controlled diets, and metabolic feeding regimens). - Monitors participant adherence to dietary protocols and document deviations according to Good Clinical Practice (GCP). - Oversees accurate and consistent collection of nutrition-related data such as dietary intake records, anthropometrics, body composition metrics, and metabolic measurements. - Ensures all diet-related procedures comply with IRB, FDA, and study sponsor requirements. - Maintains high-quality documentation and audit-ready records across all network sites. - Partners with principal investigators, study coordinators, nurses, and other clinical staff to implement protocol-specific nutrition workflows. - Trains site personnel on nutrition procedures, dietary recording methods, and use of nutrition assessment tools. - Serves as the nutrition subject matter expert for multi-site conference calls, site initiation visits, and monitoring visits. - Collaborates with central research administration to develop standardized operating procedures (SOPs) for nutrition and metabolic unit operations. - Works with purchasing and vendor management teams to ensure standardized food products and supplements across all network sites, when applicable. - Participates in quality improvement initiatives aimed at improving nutritional protocol adherence and study participant experience. - Ensures compliance with local, state, and federal regulations governing nutrition practice in research. - Maintains current knowledge of emerging nutrition science relevant to active or upcoming studies. - Adheres to ethical research practices, GCP, and confidentiality requirements. - Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. - Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. - Education/Experience/Skills: - Must be able to effectively communicate verbally and in writing. - Current Registered Dietitian (RD/RDN) credential. - 1–3+ years of clinical nutrition experience preferred. - Experience in clinical research, academic medical centers, or metabolic studies strongly preferred. - Familiarity with GCP, IRB processes, and protocol-driven research highly desirable. - Strong knowledge of clinical nutrition, dietary assessment methods, and therapeutic diets. - Expertise in interpreting research protocols and applying nutrition science in controlled research settings. - Excellent interpersonal skills with ability to work collaboratively across investigators, clinicians, and operations teams. - Strong organizational skills and meticulous attention to detail. - Proficiency with nutrition software, EMRs, dietary analysis tools, and research documentation platforms. - Ability to work independently across multiple sites and manage competing priorities. - Working Conditions - Indoor, Clinic environment. - Essential physical requirements include sitting, typing, standing, and walking. - Lightly active position, occasional lifting of up to 20 pounds. - Reporting to work, as scheduled, is essential. - May involve on-site, hybrid, or remote responsibilities depending on study needs. - Travel to network sites for training, monitoring, and study support may be required. - CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

• The Product Manager is responsible for defining, delivering, and continuously improving healthcare technology products that support clinical, operational, and patient outcomes. • Working within an Agile development framework, this role collaborates closely with engineering, design, clinical stakeholders, and business teams to translate healthcare needs into scalable, compliant, and user-centered digital solutions. • The Product Manager owns the product roadmap, prioritizes features, and ensures that product development aligns with regulatory requirements, market needs, and organizational strategy. • Define and communicate the product vision, strategy, and roadmap for healthcare technology solutions. • Identify market opportunities and user needs through research, analytics, and stakeholder engagement. • Align product goals with organizational objectives and healthcare industry trends. • Maintain and prioritize the product backlog in collaboration with Agile development teams. • Write clear user stories, acceptance criteria, and product requirements. • Participate actively in Agile ceremonies including sprint planning, backlog grooming, stand-ups, sprint reviews, and retrospectives. • Work with clinicians, healthcare administrators, compliance teams, and customers to gather requirements and validate product features. • Collaborate with UX/UI designers and engineering teams to deliver intuitive, high-quality solutions. • Ensure products comply with healthcare regulations and standards (e.g., HIPAA, interoperability standards, data security).

• Monitors clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements • Conducts site selection, initiation, monitoring, and close-out visits • Reviews case report forms (CRFs) for accuracy and completeness • Verifies source documents to ensure data integrity • Liaises between sponsors and clinical trial sites to resolve issues • Ensures timely reporting and resolution of adverse events • Maintains and updates study documentation and records • Trains site staff on study protocols and compliance procedures • Ensures proper handling and storage of investigational products • Prepares monitoring visit reports and presents findings • Assumes other duties and responsibilities as assigned

• Oversees the planning, execution, and close-out of clinical research studies for single and multi-site studies • Ensures operational excellence, regulatory compliance, and timely delivery of study milestones • Leads cross-functional teams through all phases of clinical trial execution • Develops and manages project timelines and deliverables • Monitors progress against milestones and proactively addresses risks or delays • Tracks enrollment metrics, protocol deviations, and site performance • Optimizes resource allocation and capacity planning • Coordinates with sponsors, CROs, and internal teams to ensure alignment • Maintains Trial Master Files (TMF) • Supports audit readiness and CAPA implementation