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Loyal Source jobs

- 22 jobs
  • VP, Manufacturing

    Loyal 4.7company rating

    Remote Loyal job

    Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role We're seeking an experienced Vice President, Manufacturing to lead all aspects of drug product (DP) manufacturing and packaging operations for Loyal's small molecule, oral solid dosage (OSD) programs. This role is essential to ensuring late-stage manufacturing execution, product launch readiness, commercial manufacturing oversight, and long-term supply continuity. The VP of Manufacturing will guide internal and external teams through process validation, PPQ, commercial technology transfer, packaging validation, and the establishment of commercial manufacturing operations. This leader will also oversee drug product process development for early-stage programs, ensuring that processes are scientifically rigorous, scalable, and positioned for smooth transition into late-stage and commercial manufacturing. In addition, the VP of Manufacturing will author and review manufacturing-related CMC submission sections, lead technical responses to regulatory agencies, and participate directly in regulatory interactions. You will work closely with Quality and Regulatory to prepare for pre-approval inspections (PAIs) and ensure manufacturing and packaging operations meet global regulatory expectations. This role partners closely with Supply Chain to ensure launch readiness, demand planning, inventory strategy, and commercial supply continuity across Loyal's CDMO network. This position reports to the Chief Technical Operations Officer. Your daily work will include Lead all drug product manufacturing and packaging operations from late-stage development through commercial launch and ongoing commercial supply. Oversee process validation, PPQ, and commercial technology transfer to commercial manufacturing sites. Provide oversight and technical guidance for early-stage drug product process development, ensuring scalable, robust, and well-controlled processes. Drive CDMO selection, contracting, and governance, ensuring strong technical performance, quality, and supply reliability. Ensure manufacturing and packaging operations meet GMP compliance, process robustness, and global regulatory expectations. Author and review manufacturing-related CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and container-closure documentation. Lead technical interactions with regulatory authorities, including preparing briefing materials, responding to inquiries, and representing manufacturing during regulatory meetings. Support preparation and readiness for pre-approval inspections (PAIs), including technical documentation, training, and site responses. Partner with Quality to support technical investigations, root-cause analyses, and CAPA development. Contribute to process lifecycle management, including post-approval changes, continued process verification (CPV), and ongoing optimization. Partner with Supply Chain on launch readiness, production planning, technical supply risk assessment, and commercial supply continuity. Build, mentor, and lead a high-performing team supporting manufacturing, packaging, and technical operations. About you PhD in Chemical Engineering or a closely related discipline preferred; MS/BS candidates with extensive relevant experience will also be considered. 15+ years of experience in pharmaceutical/biopharmaceutical manufacturing covering the full product lifecycle - early development, late-stage development, product launch, and commercial manufacturing. Experience in late-stage manufacturing, product launch, and commercial manufacturing oversight is a must. Experience building and scaling commercial manufacturing and packaging capabilities is a must. Experience supporting or overseeing early-stage drug product process development. Proven expertise in small molecule, oral solid dosage manufacturing, including tech transfer, PPQ, and process validation. Strong experience overseeing packaging operations, including packaging readiness and validation. Demonstrated ability to author manufacturing-related regulatory submission sections and respond to agency queries. Experience participating in or preparing for regulatory inspections, including PAIs. Strong understanding of GMP regulations and global manufacturing expectations (FDA, EMA, ICH). Experience leading technical investigations, root-cause analyses, and CAPA development. Demonstrated success establishing governance with CDMOs, including technical and quality oversight. Effective cross-functional leader with strong communication and collaboration skills. Strategic, hands-on leader who thrives in a fast-paced, mission-driven biotech environment. Experience with lifecycle management, continued process verification, and post-launch operations. Nice to have Experience with veterinary or animal health manufacturing. Passion for Loyal's mission to bring science-driven longevity therapeutics to dogs. Salary range: $270,000 - $320,000 Loyal benefits Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
    $270k-320k yearly Auto-Apply 40d ago
  • Clinical Development Veterinarian

    Loyal 4.7company rating

    Remote Loyal job

    Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. We're seeking an experienced Clinical Development Veterinarian that is responsible for veterinary medical operational aspects of clinical trials in Loyal's individual drug programs. This includes but is not limited to scientific backgrounding (pharmacokinetics / pharmacodynamics) of new animal medications, medical monitoring of clinical trial data in real time, communicating with practicing clinical veterinary investigators, safety data management, and written communications with FDA CVM. The work will sustain existing clinical trials with medical monitoring and directly impact movement of Loyal's drug programs forward into the clinical space. You will be reporting to our Clinical Development Director. Your daily work will include: Primarily medical monitoring of ongoing clinical trials, requiring: Solid understanding of the pharmacology/toxicology profile of drug compounds. Strong clinical competency in assessing medical observations/lab findings. Critical thinking skills required to assess comorbidities and study drug safety in an individual clinical trial subject. Advising our research monitors and clinical operations leaders, helping make decisions that support both our clinical investigators and our study teams. Analyzing R&D data to leverage results to execute optimal clinical trials. Mastering protocol and procedures of ongoing clinical trials and contributing to the design and development of new aging drugs for dogs, starting from preclinical studies through full FDA CVM approval. Serving as subject matter expert, translating veterinary knowledge across R&D, drug development, and clinical operations while advising teams on the veterinary perspective. Focusing on attention to detail and meticulous record keeping to bring precision and accuracy to medical monitoring, record keeping, and reviewing clinical data and regulatory documents. Upholding GCP standards and following FDA CVM regulations. Occasional travel is required. About you: DVM or equivalent degree required. Minimum of 7 years experience, clinical proficiency a must. Excellent verbal and written communication skills to clearly communicate scientific concepts and translate pre-clinical studies into the design and execution of clinical studies. A proven history of collaboration - being a veterinarian at Loyal has wide-reaching influence, with touchpoints across nearly every team. You have a self-starter mindset and ability to work independently and a commitment to keeping timelines and completion of tasks. A growth mindset that's flexible and adaptive to change in a fast-paced, start up environment. Salary range: $130,000 - $160,000 Loyal benefits: Full-coverage health insurance - medical, dental and vision - for you and your dependents. $1,000 home office equipment stipend. $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
    $130k-160k yearly Auto-Apply 60d+ ago
  • Head of Policy, Advocacy, and Communications (PAC)

    Clinton Health Access Initiative 4.5company rating

    Remote job

    The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to our mission of saving lives and reducing the burden of disease in low-and middle-income countries. We work at the invitation of governments to support them and the private sector to create and sustain high-quality health systems. CHAI was founded in 2002 in response to the HIV/AIDS epidemic, with the goal of dramatically reducing the price of life-saving drugs and increasing access to these medicines in the countries with the highest burden of the disease. Over the following two decades, CHAI has expanded its focus. Today, along with HIV, we work in conjunction with our partners to prevent and treat infectious diseases such as COVID-19, malaria, tuberculosis, and hepatitis. Our work has also expanded into cancer, diabetes, hypertension, and other non-communicable diseases, and we work to accelerate the rollout of lifesaving vaccines, reduce maternal and child mortality, combat chronic malnutrition, and increase access to assistive technology. We are investing in horizontal approaches to strengthen health systems through programs in human resources for health, digital health, and health financing. With each new and innovative program, our strategy is grounded in maximizing sustainable impact at scale, ensuring that governments lead the solutions, that programs are designed to scale nationally, and learnings are shared globally. At CHAI, our people are our greatest asset, and none of this work would be possible without their talent, time, dedication, and passion for our mission and values. We are a highly diverse team of enthusiastic individuals across 40 countries with a broad range of skill sets and life experiences. CHAI is deeply grounded in the countries we work in, with the majority of our staff based in program countries. Learn more about our exciting work: ********************************** CHAI is an Equal Opportunity Employer, and is committed to providing an environment of fairness, and mutual respect where all applicants have access to equal employment opportunities. CHAI values diversity and inclusion, and recognizes that our mission is best advanced by the leadership and contributions of people with diverse experience, backgrounds, and culture. Team Overview The international development landscape has changed dramatically since the beginning of 2025, with the global health community now having to achieve results with significantly fewer resources. CHAI is uniquely positioned to elevate national voices, shape debates from behind the scenes, and leverage our deep implementation experience to ensure that advocacy on critical global health issues is grounded in practical learnings from sustained, hands-on engagement. To help shape and advocate for this next phase of global health, CHAI is establishing a Policy, Advocacy, and Communications (PAC) function. This role has been created to design, lead, and grow the function from inception, positioning CHAI as a trusted voice and catalyst for change. The Head of PAC will drive CHAI's global vision to remove systems barriers, shape and influence policies in global health, and enhance CHAI's visibility as a catalytic thought leader and trusted partner to key stakeholders including donors, media, and partners across the global health ecosystem. CHAI's new PAC team will focus on the following areas: Policy: Translate evidence to influence critical global policymakers to accelerate health access and systems strengthening, anchored in CHAI's on-the-ground implementation experience. Advocacy: Design and execute targeted advocacy strategies to influence key decision-makers at the national, regional, and global levels, securing durable policy change. Cultivate and leverage champions and influencers to amplify impact and build momentum for CHAI's priorities. Communications: CHAI's Global Communications team will join this newly created function, which currently serves as the central hub for organizational communications. In addition to supporting teams across the organization to develop and carry out external and internal communications strategies, the new PAC team will manage CHAI's brand and voice globally-developing messaging, identifying key audiences, working with the media, disseminating reports, managing external digital platforms (including CHAI's website and social media), and collaborating with partners and donors on communications efforts. Position Overview CHAI is seeking an experienced, visionary senior leader to serve as Head of Policy, Advocacy, and Communications (PAC), establishing and leading a new function to drive impact through sector influence across CHAI's portfolio of 20+ global programs in 35+ countries. The Head of PAC will work closely with senior leadership, country teams, and global program teams to develop and execute comprehensive policy, advocacy, and communications strategies for CHAI. They will work closely with the Chief Executive Officer and senior leadership and will oversee the existing Global Communications team while being responsible for establishing and growing a new Policy and Advocacy team. This individual will be a strategic thinker and persuasive advocate with experience navigating complex global health or humanitarian policy environments. They will have proven networks and the ability to engage senior policymakers and leaders across the international development sector, present data-driven and evidence-based recommendations, and strengthen the organization's positioning on the global stage. They will also be responsible for building and managing a high-performing team, including hiring additional staff as the PAC function grows, managing departmental budgets, and contributing to organizational decision-making processes. As part of CHAI Leadership, the Head of PAC will play a critical role in shaping organizational strategy and positioning CHAI for the future. They will grow a high-performing team anchored by a comprehensive PAC strategy. The Head of PAC, like all CHAI leaders, will represent CHAI externally and elevate CHAI's evidence, innovations, and implementation experience, enabling partnership with governments, foundations, and multilateral institutions to drive system-wide change and achieve impact at scale. This is a fully remote position, with candidates expected to be based in one of CHAI's operational countries, including the United States. The position will involve approximately 20 percent international travel. Responsibilities Policy, Advocacy, and Communications Leadership (40%) Work closely with the CEO and senior CHAI leadership, with direct responsibility for both establishing a new Policy & Advocacy function and overseeing CHAI's existing central Global Communications team. Lead the development and execution of a comprehensive PAC strategy that leverages CHAI's expertise to shape health priorities globally, regionally, and nationally. Establish CHAI as a leading voice on critical health policy issues through strategic relationship building and thought leadership. Identify and forecast emerging trends in global health and synthesize them into actionable insights, building trusted relationships with decision-makers and proactively shaping policy debates on critical issues. Partner with program teams to translate programmatic insights into actionable policy recommendations and communications plans. Amplify CHAI's programmatic impact and sectoral influence by developing and executing targeted policy, advocacy, and communications strategies. Oversee CHAI's central communications portfolio, ensuring consistency of messaging and brand across the organization. Approximately 75% of the role will focus on policy and advocacy, and 25% on organizational communications. Manage the Global Communications team, a team of ~2-4 staff that work remotely, with responsibility for recruitment, professional development, and performance management. Establish and grow the new Policy and Advocacy team (size to be determined over time) responsible for executing CHAI's policy and advocacy strategy. Develop and manage departmental budgets, and contribute to organizational fundraising and strategic decision-making as part of CHAI's senior leadership. Lead risk management and crisis communications initiatives. External Engagement and Advocacy (30%) Lead engagements with government officials, UN agencies, multilateral institutions, bilateral donors, and other key stakeholders to advance CHAI's priorities. Represent CHAI as senior spokesperson across policy forums, committees, external audiences, and meetings with donors and policymakers globally. Cultivate relationships with journalists and media outlets, proactively pitching stories and securing coverage to advance CHAI's policy, advocacy, and communications goals. Develop and execute advocacy strategies for priority policy issues, including power mapping, stakeholder analysis, and targeted initiatives. Identify, cultivate, and engage champions and influencers - including government leaders, civil society, and other high-profile voices - to amplify CHAI's priorities and drive durable policy change. Build strategic partnerships and coalitions to advance shared objectives. Plan and leverage experts from across CHAI to lead engagement for impactful engagement events, including webinars, press conferences, and other relevant convenings. Research & Content Development (30%) Analyze and forecast key shifts and moments of opportunity in CHAI's core domains, and design PAC strategies to maximize influence and impact. Create frameworks to assess policy impact and feasibility across different country contexts. Amplify CHAI's thought leadership by spearheading the development, writing, and editing of materials such as annual reports, leadership documents, talking points, press releases, white papers, and technical recommendations. Oversee CHAI's digital communications channels, including website updates, blogs, and social media content, ensuring they reflect organizational priorities and amplify CHAI's policy, advocacy, and communications goals. Provide strategic communications support to CHAI leadership, including briefing memos, speeches, presentations, or op-eds. Qualifications Advanced degree required (Master's, JD, or equivalent), preferably in public policy, international relations, public health, or related field. 15+ years of progressive experience in policy development, advocacy, and communications, with at least 5 years in senior leadership roles. Experience managing and building high-performing teams. Deep experience and network working with governments, multilateral institutions, and nonprofit partners on health or development policy. Demonstrated track record of developing and executing successful policy-shaping that achieved measurable impact. Strong understanding of the global health landscape and key technical areas. Excellent analytical and strategic thinking skills, with ability to translate complex issues into actionable recommendations. Outstanding written and verbal communication skills, including public speaking, media engagement, and briefing senior officials. A demonstrated ability to generate high-quality media coverage. Ability to navigate a fast-paced environment while balancing multiple priorities, serving diverse internal stakeholders, and effectively prioritizing across several functions. Ability to work across cultures and in resource-constrained settings. Political acumen and relationship-building skills at senior levels of government and international organizations. Advantages: Experience working in or with low- and middle-income country governments. Previous experience working in US Government and/or non-profit environments. Established relationships with key stakeholders including donors, UN agencies, and media outlets covering global health, international development, or related fields. Professional fluency in additional languages, such as French or Spanish. #jobreference4 #region1 #region2 #region3 #region4
    $66k-109k yearly est. Auto-Apply 60d+ ago
  • Technical Recruiter

    Loyal Source 4.7company rating

    Loyal Source job in Orlando, FL

    In this recruiter role, you will be responsible for providing full-cycle recruitment, selection and interview processes for critical positions located throughout the United States and international locations. Frequent recruitment areas include Security Integration, Engineering, Logistics, Training and Aviation Field Services for customers in the Department of Defense, Civil Agencies and commercial industry partners. Duties and Functions * Full-cycle recruitment using traditional and non-traditional sourcing techniques to include researching and identifying markets to source for qualified talent * Proactively prospect, identify and recruit qualified candidates using various resources to include: extensive internet mining of job boards and search engines, Salesforce, LinkedIn, ZoomInfo), social media sites, cold calls and extensive networking * Conducting telephone and video interviews for all potential hires * Processing employment and clearance paperwork * Ability to work in a time-sensitive environment Education and Experience * Bachelor's Degree or higher in Human Resources, Business, Management or related field * Minimum of 0 years recruiting technical labor categories Preferred Requirements * MS Office experience (Excel, Word & Outlook) * Familiarity with social media and networking sites * Verifiable organizational membership/leadership role (fraternity/sorority, sports team, club officer, etc.) Knowledge/Skills/Abilities (KSA) Knowledge-comprehension of a body of information acquired by experience or study. Skill-a present, observable competence to perform a learned activity. Ability-competence to perform an observable behavior or behavior that results in an observable product. Supervisory Responsibilities Will this position have supervisory responsibilities? None What positions will they supervise? None Pay: 50,000 Work Environment/Condition This position operates in a professional office environment. The role uses standard office equipment. Physical Demands Prolonged periods sitting at a desk and working on a computer Must be able to lift up to 15 pounds at times. Acknowledgement Loyal Source does not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factors. This is not an exclusive or exhaustive list of all job functions that an employee in this position may be asked to perform. All employees are required to perform the essential functions, physical demands and intended purpose of their role in a satisfactory manner. I attest that I can perform the essential job functions as outlined in this with or without any reasonable accommodation(s). I understand if I want to inquire about or seek reasonable accommodations, I am required to contact Human Resources at ******************. I acknowledge that I have read and understand the essential job functions, work environment/conditions, exemption classification and physical demands set forth in the job description provided for my position. Loyal Source is an Orlando-based workforce solutions provider dedicated to delivering elite services worldwide. With a focus in government healthcare, technical and support services, engineering, and travel healthcare, Loyal Source provides exceptional custom solutions to both private enterprise and government agencies. Loyal Source is a military friendly employers and proud partner of the Military Spouse Employment Partnership program. For more information go to our website ******************* and follow us on LinkedIn, Facebook & Twitter for other positions currently open. Loyal Source does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. This contractor and subcontractor abides by the requirements of 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors.
    $46k-62k yearly est. 6d ago
  • Quality Assurance Coordinator (Clinical Research)

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Essential Responsibilities and Duties: Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines. Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations. Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present. Prepares for internal and external audits and FDA inspections. Attends staff meetings. Attends site initiation visits 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. 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 in English and Spanish. High school graduate or equivalent, Bachelors degree or equivalent preferred. Minimum 1-2 years relevant experience in the clinical research industry. Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills - both written and oral. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must be able to clearly communicate through written and verbal means with sponsors and staff. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On-site 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.
    $41k-60k yearly est. 36d ago
  • Sr. Scientist, CMC Analytical

    Loyal 4.7company rating

    Remote Loyal job

    Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role We're seeking an experienced Sr. Scientist, CMC Analytical to serve as the SME in analytical methods and data interpretation, providing advanced technical analysis of data generated during product release, stability testing, and method lifecycle activities. This role requires deep expertise in analytical method development, data trending and interpretation, with the ability to translate findings into actionable insights that inform quality decisions and regulatory strategy. Your work will ensure that robust, phase-appropriate analytical methods and data packages support product quality, regulatory compliance, and successful advancement of therapies from early development through commercialization. This role is for someone who applies strong technical judgment to ensure robust product understanding, reliable quality control performance, and continuous method improvement throughout clinical development and commercialization.This role is for someone who has extensive experience with method development for small molecule drug product and API testing particularly with new chemical entities. The ideal candidate should be able to critically review all data for potential trends or issues. Experience managing outside labs is a plus. You will be reporting to our Sr. Manager, CMC Analytical. Your daily work will include: Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs. Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long-term stability. Provide expert technical input during OOS, OOT, and atypical result investigations, ensuring scientifically sound conclusions. Lead trending of release and stability data across programs, highlighting emerging quality signals and risks. Review and assess data from method development, transfer, qualification, and validation activities. Ensure Quality Control data packages are complete, scientifically defensible, and compliant with cGMP and regulatory expectations. About you: A Bachelor's or Advanced degree (master's or Ph.D.) in Analytical Chemistry, Chemistry, Biochemistry or a related field. Animal Health experience strongly preferred. 6+ years of experience in quality control laboratory, analytical or method development, with significant experience with small molecules preferred. Deep and broad knowledge of analytical chemistry in support of small molecule release and stability method development, raw material control, in process control, and characterization. Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired. Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations. Proven track record of QC data interpretation and support of regulatory filings. Creative and thoughtful approach to problem solving technical issues. Ability to quickly learn new concepts and processes. Adaptability, creativity and high-performer in risk-assessment and strategic thinking. Detailed eye for logistics and problem solving. Willing to work and comfortable in a fast-paced startup environment with a dynamic team. Clear and polite communication skills. Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.). Salary: $125,000 - $145,000 Loyal benefits: Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
    $125k-145k yearly Auto-Apply 9d ago
  • Sr. Principal, Packaging Engineering

    Loyal 4.7company rating

    Remote Loyal job

    Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role We're seeking an experienced Sr. Principal, Packaging Engineering to lead all aspects of packaging process development, qualification, validation, launch readiness, and commercial supply for Loyal's small molecule, oral solid dosage (OSD) products. This role is responsible for packaging operations across the entire product lifecycle - from development through commercial execution - and will drive CDMO selection and management, packaging process development, packaging line readiness, and packaging validation (IQ/OQ/PQ). You will ensure that Loyal's packaging systems are robust, compliant, and ready to support product launch and ongoing commercial supply. The ideal candidate brings deep expertise in OSD packaging engineering, strong experience with external packaging and manufacturing partners, and the ability to deliver packaging strategies and solutions that meet regulatory, technical, operational, and commercial requirements. Experience with veterinary products is a plus but not required. This role reports to the Vice President, Manufacturing. Your daily work will include Lead packaging process development, scale-up, and optimization for OSD drug products. Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations. Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements. Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness. Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs. Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity. Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries. Support or participate in PAIs and other regulatory interactions related to packaging. Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations. Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs. Drive continuous improvement across packaging operations, materials, and systems. Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Regulatory, Formulation, and Analytical Development to ensure packaging readiness across all development and commercial stages. About you Bachelor's, Master's, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field. 10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, with significant experience supporting commercial or late-stage OSD products. Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container-closure systems. Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ). Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations. Experience supporting commercial packaging operations, including launch readiness and ongoing supply. Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to packaging-related regulatory questions. Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards. Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements. Experience supporting or participating in pre-approval inspections (PAIs) related to packaging. Demonstrated excellence in risk assessments (FMEA) and packaging investigation methodologies (RCA, CAPA). Effective cross-functional collaborator with strong project leadership and external partner management skills. Hands-on, proactive, and thrives in a fast-paced, mission-driven biotech environment. Experience launching packaging operations in a lean or emerging commercial organization. Experience with veterinary or animal health packaging is a plus. Nice to have Experience with veterinary or animal health manufacturing. Passion for Loyal's mission to bring science-driven longevity therapeutics to dogs. Salary range: $180,000 - $240,000 Loyal benefits Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
    $180k-240k yearly Auto-Apply 18d ago
  • Clinical Rater

    Cenexel 4.3company rating

    Tampa, FL job

    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. 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: Responsible for performing various clinical and neurocognitive test evaluations and interview/ratings on study participants specific to the study protocol. To administer and score tests evaluating cognitive, neuropsychological, behavioral, and emotional status. Essential Responsibilities and Duties: Perform interview/ratings on study subjects to determine current levels of functioning and to create a clinical impression of the subject's current psychiatric state throughout the duration of the study Administer neurocognitive battery in subject with different CNS indications Complete subject's clinical intake forms (i.e. psychiatric history) and submit to the study team as specified Assess and complete subject eligibility/screening forms and interact with medical monitor regarding subjects inquiries Conduct telephone screens and pre-screen with potential study candidates Become familiar with and adhere to policies and principles of confidentiality, informed consent and study subject rights Become familiar with and adhere to the principles of Good Clinical Practices and general ethical guidelines, as related to clinical trials Become familiar with the FDA Regulations pertaining to clinical trials Review medical history with CRC information obtained at screening Review and reconcile medical records received for subjects and prepare PI notes to explain discrepancies, if needed Complete Study Guides and Study Launch with CRC Assist team in management and assessment of adverse events Ensure safety of subjects Assist with recruitment efforts Mentor staff, as needed 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. Master's Degree and/or Ph.D/Psy.D in Psychology, or related field required. 1-2 years clinical experience with the mental health population. Skill in organization and problem solving. Skill in maintaining records. Skill in developing and maintaining effective working relationships with study participants, families, staff and the public. Ability to complete paperwork with precision and attention to detail. Ability to interpret, adapt and apply guidelines and procedures. Ability to work independently as well as functioning as part of a team. Ability to communicate clearly both written and orally. Working Conditions Indoor, Clinic environment. Essential physical requirements include sitting, typing, standing, 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.
    $26k-41k yearly est. 11d ago
  • Quality Assurance Auditor

    Loyal Source 4.7company rating

    Loyal Source job in Florida

    This position is a full-time remote Quality Assurance (QA) Auditor position working for Loyal Source Government Services (LSGS). The QA Auditor is responsible for conducting independent, corporate level objective assessments of program and site operations to ensure compliance with contractual and Performance Work Statement (PWS) obligations, industry standards, and key performance indicators (KPIs). This role requires observing and analyzing operational processes and reporting findings to program and LSGS leadership in support of creating forecast projections of quality performance and customer satisfaction. Regular and potentially short notice travel to multiple locations is expected to be up to 50 to 75%. Key Responsibilities: * Conduct independent site visits to program offices and medical clinics to assess compliance with contractual obligations, program plans and KPIs * Conduct in-briefs on audit approach and exit briefs on results with onsite managers * Observe onsite workflows, patient or customer experience, and overall operational efficiency and quality * Analyze and interpret data from site assessments to identify trends, risks, and areas for improvement * Conduct subcontractor management quality reviews per program subcontract management, quality management or program management plans * Stay up to date on industry regulations, quality standards, best practices and process optimization strategies * Maintain accurate documentation of assessments and recommendations * Prepare and present detailed post-site visit reports summarizing and detailing findings * Foster a culture of continual improvement, accountability and excellence * Collaborate with LSGS Quality and program leadership to support the continual improvement of the assessments and reports * Assist with viewing potential new site locations and assist with new site set up Other major duties the QA Auditor will be involved with as part of the LSGS Corporate Quality team include: * Assist and develop and recommend corrective action plans to address identified non-compliance issues. * Assist and develop strategies to mitigate identified risks to ensure continuous compliance. * Support updates to inspection protocols and training materials to reflect any new requirements. * Help to maintain organized records of all inspections, findings, corrective actions, and follow-up activities. * Participate and collaborate with program leadership to implement corrective actions and 5 Why Root Cause Analysis in a timely manner as necessary. * Perform follow-up inspections as necessary to ensure that corrective actions have been implemented * Develop and recommend improvement opportunities where appropriate. * The QA Auditor participates with other QA team members to review requirements, identify controls, develop audit checklists, perform oversight activities, and perform assessments of contractual requirements, environmental and safety checks, local statutes, laws, and regulations, as well as other unique requirements during periods of high production start-up, ramp ups and ongoing operations. * Other duties as requested Education and Experience * Bachelor's degree is preferred (5 years of healthcare quality assurance related experience may be considered equivalent to a bachelor's degree) * 2 to 4+ years of experience in the quality field, healthcare administration or medical field is a must * Prior QA and/or auditing experience required * Microsoft Office 365, strong written and verbal communication skills, and a valid driver's license * Strong interpersonal collaboration skills and an ability to work independently * Preferred Requirements * Experience with quality and healthcare industry standards. Examples include but are not limited to ISO 9001, CMMI for Services, National Association for Healthcare Quality (NAHQ), The Joint Commission (TJC), and Occupational Safety and Health Administration (OSHA) * Experience in an onsite or facility auditing program * Experience in Lean, Lean Six Sigma and/or performing Gemba Walks * Recent work performed within the medical field under major US Government Agencies such as Customs and Border Protection, Department of Veterans Affairs, Department of Defense, Centers for Disease Control, Health and Human Services, Office of Refugee Resettlement, or other major agencies at the State level performing similar services. Knowledge/Skills/Abilities (KSA) * Knowledge: A working understanding of the principles of quality control, quality assurance and program management in a variety of industries including Federal and State Government, Military and Healthcare. * Skill: Competence with QA Methodologies, audit techniques, data collection and analysis, root cause analysis, and excellent writing and briefing skills. * Ability: Ability to independently travel and display a high level of professionalism with onsite staff. Capability to analyze data and present observations of overall quality and program management practices, overseeing large programs with critical data and information, trend analysis, and other quality tools. Supervisory Responsibilities This is a non-supervisory position. Key Collaborators This position will collaborate with Quality team members specifically and all LSGS departments and programs in general. Work Environment/Condition The environment is generally an office type location, medical clinic, or doctor's office, generally indoors with some outdoor activity at times. Travel to clinic sites up to 75% of the time may be necessary. Travel may be on short notice. Physical Demands This position requires an individual in good health to perform their job duties in multiple locations, long periods of standing and walking with no significant limitations. Multiple forms of travel will be needed for this position, typically by airplane or driving long distances. Individuals will be traveling in various weather conditions. Travel is required, potentially 75% of the time or 2-3 weeks per month throughout the United States. Pay: Starting at $70K a year based on experience and qualifications. About Loyal Source Loyal Source is an Orlando-based workforce solutions provider dedicated to delivering elite services worldwide, with a focus in government healthcare, technical and support services, engineering, and travel healthcare. Loyal Source provides exceptional custom solutions to both private enterprise and government agencies. Loyal Source is a military friendly employer and proud partner of the Military Spouse Employment Partnership program. For more information go to our website ******************* and follow us on LinkedIn, Facebook & Twitter for other positions currently open. Loyal Source does not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factors. This contractor and subcontractor abides by the requirements of 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors.
    $70k yearly 8d ago
  • Revenue Cycle - Professional Fee Coder (Remote)

    Power Personnel 4.1company rating

    Remote or Palo Alto, CA job

    Are you a detail-oriented and experienced Professional Fee Coder? We're seeking top talent to support accurate coding, compliance, and revenue integrity in a fully remote environment. Apply now and make a meaningful impact. What the job is like Pay: $32.00 - $39.81 per hour (DOE) Schedule: 40 hours per week Days: Monday-Friday Shifts: Day shift; start time between 6:00 AM - 9:00 AM PST Location: Remote Duration: 01/05/2026 - 04/17/2026 What's in it for you Competitive pay Fully remote work environment Health / vision / dental / life insurance Refer-a-friend bonus* Weekly payroll 24-hour accessibility Personalized service MINIMUM QUALIFICATIONS Education Qualifications Associate's degree in a related field from an accredited college or university or an equivalent combination of education and experience Licenses and Certifications Candidates must have at least one of the following certifications: CPC - Certified Professional Coder CCSP - Certified Coding Specialist - Physician RHIT - Registered Health Information Technician RHIA - Registered Health Information Administrator CCS - Certified Coding Specialist Experience Minimum 2 years Professional fee coding experience, preferably in physician or radiology services Strong working knowledge of CPT-4, ICD-10-CM, HCPCS, and modifiers Required Technology & Skills Experience using EPIC and Encoder systems Proven professional coding experience Strong professional email etiquette and written communication skills Responsibilities Apply official coding guidelines to assign accurate CPT-4, ICD-9-CM, HCPCS codes, and modifiers Code all documented professional services and submit charges for billing Ensure documentation supports coded services and meets compliance standards Resolve pre-bill edits and follow up on discrepancies Collaborate with departments to optimize reimbursement and reduce late or missed charges Provide routine feedback to physicians regarding documentation and compliance opportunities Query providers when documentation is unclear, incomplete, or ambiguous Ensure all professional services are submitted timely and accurately Maintain current knowledge of coding guidelines and reimbursement requirements Utilize correct coding practices to support clean claims and improved cash flow Required Knowledge, Skills, and Abilities Ability to plan, organize, prioritize, and meet deadlines independently Ability to adapt to change and work effectively in ambiguous situations Ability to analyze medical records and abstract relevant coding information Knowledge of medical terminology, anatomy, physiology, and disease processes Ability to work effectively with individuals at all organizational levels Proficiency with coding systems, compliance standards, and healthcare software Who we are Power Personnel has been working with healthcare professionals like you since 1994. We are the experts in healthcare staffing in Northern California. That's why so many hospitals, clinics, and healthcare facilities rely on us to fill critical positions. If you want competitive pay, excellent working conditions, and a team that supports you, Power Personnel is the place to be! Refer a friend at referrals@powerpersonnel.com and get a $250 bonus for every referral!* *In order to get the bonus, the person referred must work at least 20 shifts.
    $32-39.8 hourly 6d ago
  • Director, Clinical Development

    Loyal 4.7company rating

    Remote Loyal job

    Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role The Director of Clinical Development leads the team responsible for design, execution, and strategic direction of clinical programs across Loyal's veterinary product portfolio. This role is responsible for driving end-to-end clinical strategy, from target product profile to study design and regulatory-facing protocol development through field execution, data interpretation, and evidence package generation. Experience in human clinical drug development is considered if candidates demonstrate the ability to translate human clinical rigor into the realities and constraints of veterinary medicine (owner compliance, clinic workflow, clinical trial models, and companion animal endpoints). This is a highly cross-functional role that partners closely with Veterinary Affairs, Clinical Operations, Regulatory (FDA-CVM),CMC, and Commercial to ensure our studies are scientifically sound, operationally feasible, and aligned with pathways to approval. You will be reporting to our VP, Clinical and Veterinary Medicine . Your daily work will include: Clinical Strategy & Program Development Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations. Build and manage detailed timelines for product development Communicate strategy and development timelines across multiple teams within Loyal Study Design & Protocol Development Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability). Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings. Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans. Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase. Study Execution & Medical Oversight Provide medical and scientific oversight for all clinical studies, including: Eligibility decisions Case reviews and AE/SAE reporting Protocol deviations and issue escalation Interpretation of clinical data trends during trial execution Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks. Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops. Regulatory Leadership (FDA-CVM) Lead clinical components of regulatory interactions, including: Pre-Submission meetings Technical section responses Study protocol reviews with regulators Evidence summaries for FOI packages Ensure that all clinical components meet VICH, GCP, and CVM guidance standards. Cross-Functional Collaboration Work tightly with: R&D to vet new drug targets and mechanisms and interpret pre-clinical data Regulatory to align development plans with CVM requirements. Veterinary Affairs to ensure clinic workflows and veterinary input shape study design. Clinical Operations on execution strategy, site selection, and quality. Commercial to ensure label-enabling claims are supported by data. Data Interpretation & Evidence Generation Lead clinical data review, analyses, and messaging strategy. Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications. Author study reports, abstracts and external presentations as needed. Team Leadership Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds. Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design About you: DVM or equivalent. 8-12+ years of experience in clinical development in animal health clinical development. Demonstrated experience designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration. Prior oversight of safety evaluation, study conduct, and interpretation of clinical endpoints. Strong understanding of evidence requirements for regulatory approval. Ability to lead in a fast-paced, high-accountability biotech environment. Required Direct experience with FDA-CVM VICH guidelines. Experience in companion animal medicine, bonus if experience is in aging/longevity or quality-of-life endpoints. Background working with veterinary clinics, practice networks, or decentralized trial models. Salary Range: $165,000 - $200,000 Loyal benefits: Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
    $165k-200k yearly Auto-Apply 17d ago
  • Medical Assistant (Clinical Research)

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. 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: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Phlebotomy experience preferred. Experience working with patients. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally in both English and Spanish. 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.
    $27k-35k yearly est. 21d ago
  • Business Development Manager - AI & Emerging Tech

    Loyal Source 4.7company rating

    Loyal Source job in Orlando, FL

    This is a hunter position for a staffing sales professional passionate about emerging technologies. You will drive growth in AI, machine learning, and advanced technology staffing. Candidates must have staffing industry experience and ideally have sold into tech companies or advanced technology sectors. Duties and Functions * Actively pursue new business opportunities in AI and emerging tech companies. * Promote Client development and build relationships with prospective clients through office visits, presentations and negotiations. * Develop proposals for workforce solutions tailored to cutting-edge technology roles. * Maintain strong industry knowledge and consultative approach. * Collaborate with recruiting teams to ensure delivery excellence. * Utilize CRM/ATS for pipeline management and reporting. Education and Experience * Bachelor's degree required. * Must have staffing industry experience with proven success in new business development. * Experience selling into AI, tech, or advanced technology sectors preferred. * Strong B2B sales and relationship-building skills. * Excellent communication and negotiation skills. Preferred Requirements * 2 - 5 years of experience selling staffing services. * Ability to travel nationwide to meet clients and prospects. Knowledge/Skills/Abilities (KSA) Knowledge-Understanding of the staffing industry, sales process and the specialties withing the industry Skill-Excellent communication and negotiation skills. Cold call and develop new business. Ability-Build new markets and manage multiple opportunities Supervisory Responsibilities None Work Environment/Condition This position operates in a professional office environment. The role uses standard office equipment. Travel as required. Physical Demands Prolonged periods sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Loyal Source is an Orlando-based workforce solutions provider dedicated to delivering elite services worldwide. With a focus in government healthcare, technical and support services, engineering, and travel healthcare, Loyal Source provides exceptional custom solutions to both private enterprise and government agencies. Loyal Source is a military friendly employers and proud partner of the Military Spouse Employment Partnership program. For more information go to our website ******************* and follow us on LinkedIn, Facebook & Twitter for other positions currently open. Loyal Source does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. This contractor and subcontractor abides by the requirements of 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors.
    $53k-85k yearly est. 8d ago
  • PRN Registered Nurse (Night Shifts - 530 pm - 6 am)

    Cenexel 4.3company rating

    Tampa, FL job

    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. Job Summary: With moderate oversight, the Clinical Research RN I is responsible for overseeing the implementation of daily clinical study activities. Serving as a liaison between the investigative site and the Sponsor. Responsible for accurately and ethically documenting all information obtained throughout the clinical research process. Essential Responsibilities and Duties: Provides general nursing care to study participants as necessary; including, but not limited to monitoring of vitals, blood sugar, vital signs, lab tests, etc. Reviews and executes clinical research protocols. Completes and maintains study documents in accordance with sponsor and site requirements. Possible recruitment of potential study subjects. Screens subjects for eligibility, and schedules subjects for study specific assessments, as designated on the Delegation of Authority Log. Completes and maintains Case Report Forms in agreement with the source documentation and in accordance with study protocol. Accompanies sponsor representatives during their visits and maintains effective and ongoing communication with the sponsor. Maintains adequate inventory of all data and supplies. Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned. Observes, documents, reports, and follows up on adverse events and serious adverse events. Conducts the informed consent process, per CenExel Standard Operating Procedures. Follows up appropriately on all laboratory results. Maintains safety standards when performing job responsibilities. Maintains study logs and site relations Ensures proper collection, processing, and shipment (if applicable) of laboratory specimens. Assists with quality assurance activities and completes queries, as applicable. Obtains Principal Investigator signatures on necessary documents. Oversees or coordinates the administration of investigational medication and follows subjects throughout the study stay, per protocol. Ensures accountability and adequate supply for study and clinical drugs. 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 a Registered Nurse with a current license in the state in which the employee will be working, and not have any disciplinary action on the license. Must be BLS or ACLS certified or able to obtain. 0-1 year of experience is required. Must be IV certified, depending on site. Must be capable of performing all clinical tasks relevant to licensure and/or training. Must be able to clearly communicate verbally with patients. Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc. Must be self-motivated and able to perform tasks independently. Ability to react calmly and effectively in emergency situations. Must reflect the professional image of the company, upholding the company vision in actions and demeanor. Must be able to effectively communicate verbally and in writing. 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. On-site 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.
    $44k-104k yearly est. 9d ago
  • Principal Investigator/Physician

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: Responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCPs), and federal/state regulations. Generates independent, high quality, and reproducible results. Collaborate with our study team, as well as various medical, pharmaceutical company and regulatory personnel to ensure the health and welfare of study participants. Responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project. Essential Responsibilities and Duties: Maintain current license to practice medicine. Maintain current board certification, if applicable Assume responsibility as the Principal Investigator for the duration of clinical trials Strong working knowledge of regulatory requirements and GCP standards Possess thorough understanding of the clinical research protocol and patient population for which the trial is designed Ensures recruitment goals are reasonable and attainable Perform any evaluations deemed necessary for the conduct of the trial Complete training as required per sponsor's vendors to obtain certification to conduct testing and rating scales for specific protocols Conduct testing and rating scales per sponsor's instructions and protocols. Completion of all documentation, paper and electronic, as required per protocol Evaluate participants for clinical research trials based on their past medical history in comparison to the protocol specific inclusion and exclusion criteria Ensure appropriate delegation and training of the clinical research staff Educate study staff on patient population and mechanism of action of the investigational product Evaluate subject safety and compliance with the investigational product as specified in the clinical research protocol as well as collaborate with the medical director Assess participant's response to investigational therapy and evaluate any adverse events Adhere to reporting requirements for safety reports, protocol noncompliance and any other protocol required reports Ensure subject's informed consent is obtained appropriately throughout the duration of the clinical trial Adhere to the requirements detailed on the FDA 1572 or Statement of Investigator form Collaborate with Site Leadership to ensure company goals are met Provides key budgetary decisions and verifies that appropriate budgets and cost projections are prepared to deliver the proposed project scope Attend Investigator Meetings and educational seminars. 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. Possess a valid M.D. or D.O. degree. Board Certified or Eligible. 1-3 years' experience conducting clinical research trials as either a PI or Sub-investigator, or other relevant experience. D. or D.O. required. Active DEA license, or able to obtain one. Active license to practice medicine in the state of practice, or ability to obtain one. Medical knowledge and ability to provide clinical information to study teams; Knowledge of medications and general medical conditions; Knowledge and Understanding of GCP/ICH guidelines Possess a thorough understanding of the requirements of each protocol Experience in conduct of clinical trials; Demonstrating the proper education, training and experience to conduct the clinical investigation Knowledge of drug delivery systems and ability to prepare injections, infusions, etc.; Skill in organization and record maintenance; Skill in developing and maintaining effective working relationships with supervisors and co-workers; Ability to complete paperwork with precision and attention to detail; Ability to react calmly and effectively in emergency situations; Ability to interpret, adapt and apply guidelines and procedures; Ability to work independently as well as functioning as part of a team; Ability to communicate clearly, both verbally and in writing. 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. 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.
    $60k-74k yearly est. 60d+ ago
  • Pharmacy Technician

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: With moderate oversight, the Pharmacy Technician I will assist in providing support of clinical investigational drug trials; provide accurate and efficient dispensing of medication and perform cross functional duties as required. Essential Responsibilities and Duties: Monitors pharmacy activities daily to ensure adherence to study protocols and dispensing procedures. Prepare and dispense investigational drugs in accordance with the IRB-approved protocols under the supervision of the Pharmacist or site management. Assist Pharmacist or site management in preparing blinded study products. Ensure the appropriate storage of investigational drugs according to the protocol and FDA guidelines. Monitor temperature of pharmacy storage areas and alert Pharmacist or site management of any temperature excursions of study drug. Assists in ordering, receiving, unpacking and storing pharmaceuticals and supplies. Rotates stock to ensure use before expiration date. Monitors expiration date and supply of drug for clinical trials. Prepares medication for dispensing to patients enrolled in inpatient study protocols. 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. Certified Pharmacy Technician required. Minimum of 1 year related experience preferred. Knowledge of basic pharmacy practices and procedures. Knowledge of medications and medical supplies. Ability to maintain quality control standards. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt, and apply guidelines and procedures. Attention to detail. Working Conditions Indoor, Clinic environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On-site 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.
    $29k-38k yearly est. 21d ago
  • Clinical Research Coordinator

    Cenexel 4.3company rating

    Tampa, FL job

    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. 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: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. 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 have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. 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. Overnight travel may be required for training and/or investigative meetings. 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.
    $42k-61k yearly est. 11d ago
  • Clinical Research RN (Night Shift)

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: With moderate oversight, the Clinical Research RN I is responsible for overseeing the implementation of daily clinical study activities. Serving as a liaison between the investigative site and the Sponsor. Responsible for accurately and ethically documenting all information obtained throughout the clinical research process. Essential Responsibilities and Duties: Provides general nursing care to study participants as necessary; including, but not limited to monitoring of vitals, blood sugar, vital signs, lab tests, etc. Reviews and executes clinical research protocols. Completes and maintains study documents in accordance with sponsor and site requirements. Possible recruitment of potential study subjects. Screens subjects for eligibility, and schedules subjects for study specific assessments, as designated on the Delegation of Authority Log. Completes and maintains Case Report Forms in agreement with the source documentation and in accordance with study protocol. Accompanies sponsor representatives during their visits and maintains effective and ongoing communication with the sponsor. Maintains adequate inventory of all data and supplies. Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned. Observes, documents, reports, and follows up on adverse events and serious adverse events. Conducts the informed consent process, per CenExel Standard Operating Procedures. Follows up appropriately on all laboratory results. Maintains safety standards when performing job responsibilities. Maintains study logs and site relations Ensures proper collection, processing, and shipment (if applicable) of laboratory specimens. Assists with quality assurance activities and completes queries, as applicable. Obtains Principal Investigator signatures on necessary documents. Oversees or coordinates the administration of investigational medication and follows subjects throughout the study stay, per protocol. Ensures accountability and adequate supply for study and clinical drugs. 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 a Registered Nurse with a current license in the state in which the employee will be working, and not have any disciplinary action on the license. Must be BLS or ACLS certified or able to obtain. 0-1 year of psychiatric care experience is required. Must be IV certified, depending on site. Must be capable of performing all clinical tasks relevant to licensure and/or training. Must be able to clearly communicate verbally with patients. Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc. Must be self-motivated and able to perform tasks independently. Ability to react calmly and effectively in emergency situations. Must reflect the professional image of the company, upholding the company vision in actions and demeanor. Must be able to effectively communicate verbally and in writing in both English and Spanish. 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. On-site 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.
    $51k-70k yearly est. 36d ago
  • Clinical Rater

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: Responsible for performing various clinical and neurocognitive test evaluations and interview/ratings on study participants specific to the study protocol. To administer and score assessments confirming diagnosis, assessing cognitive, neuropsychological, behavioral, and functional status. Essential Responsibilities and Duties: Administers clinical rating scales on study participants to confirm diagnosis and determine current levels of psychopathology and function. Responsible for completing organizational queries regarding clinical scales and neuropsych ratings. Utilize interpersonal and clinical skills to assist in appropriate management of study participants across multiple therapeutic areas within neuroscience. Actively participates in acquiring on-going knowledge and instruction. Assists management in maintaining a positive, motivated work environment. Responsible for assisting PI to maintain integrity of data derived from clinical ratings scale and neurocognitive testing for all studies. Ensures data collection continuity during absences/sick leave/vacation of ratings staff including documentation of consensus between back-up and primary ratings. Conducts clinical research consensus rounds concerning accurate signal detection with clinical subject ratings Participates in assessment of prescreened and screening patients per PI discretion and as per protocol. Complete required study specific trainings in a timely manner. 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 in English and Spanish. Master's Degree and/or Ph.D/Psy.D in Psychology required. Minimum 2 years clinical experience with the mental health population. Skill in organization and problem solving. Skill in maintaining records. Skill in developing and maintaining effective working relationships with study participants, families, staff and the public. Ability to complete paperwork with precision and attention to detail. Ability to interpret, adapt and apply guidelines and procedures. Ability to work independently as well as functioning as part of a team. Working Conditions Indoor, Clinic environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On site 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.
    $26k-41k yearly est. 3d ago
  • Clinical Research Coordinator

    Cenexel 4.3company rating

    Hollywood, FL job

    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. 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: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). 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: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing in English and Spanish. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. 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.
    $42k-61k yearly est. 11d ago

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