Clinical research associate jobs in Miami Beach, FL - 212 jobs

Screening, enrolling, scheduling, and caring for trial participants, often taking vital signs or samples. Collecting, organizing, entering data into electronic systems, managing Trial Master Files (TMF), and preparing reports. Setting up labs, preparing study materials, ensuring adherence to the trial's protocol, and cleaning work areas. Upholding Good Clinical Practice (GCP) and regulatory standards to safeguard participants and data integrity. Serving as a liaison between participants, medical staff, sponsors, and regulatory bodies.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is “inspection ready” contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Responsible for collecting, analyzing and interpreting collected data. The Research Associate 3 will adhere to Baptist Health South Florida (BHSF) guidelines when presenting research outcomes and ensure that the highest quality of research is performed. The estimated salary range for this position is $58494.88 - $76043.34 / year depending on experience. Degrees: * Masters Degree is required. Licenses & Certifications: * Collab Inst Training Init. Additional Qualifications: * CITI certification required within 30 days of hire. * While a Master's degree of Science is a minimum requirement, candidates with PhD and MD degrees (especially those who completed their residency programs) are preferred. * Candidates must be highly organized with strong analytical, research, math and statistical skills as well has had previous experience working in an academic and/or scientific setting. Minimum Required Experience: 5 Years

Under direction of the Senior Manager of Clinical Trial Operations, the Clinical Research Coordinator II, CTO (CRC II) manages and conducts the day-to-day activities of a research study. In general, the CRC II ensures the study maintains accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a CRC II may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Job Specific Duties * Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate. * Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol. * Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance. * Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's Representatives. * Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff. * Interacts with patients and families to recruit (screen, consent and enroll) study subjects and ensures compliance with the protocol. * Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies. * Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format. * Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. * Follows NCRIs Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines. * Enters required data into CTMS. * Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS. * Works adjusted hours to accommodate subject visits. * Keeps electronic patient files and required documents up-to-date within e-regulatory system The ideal candidate has experience with Hematology/Oncology. Minimum Job Requirements * Bachelor's degree and 2 years of research experience (OR) Associate's degree and 4 years of research experience (OR) 5 years of research experience Knowledge, Skills, and Abilities * Experience in pediatric clinical research in a hospital setting. * Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred. * Experience working on clinical trials, interventional studies is preferred * Bilingual in English/Spanish. * Excellent communication skills in working with both children and adults. * Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change. * Time management skills. * Knowledge of protocols and its process. * Experience with software applications including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment. * Experience with relevant hospital equipment for each clinical trial project. * Availability to work adjusted hours to accommodate subject visits.

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. The successful candidate will be responsible for independently planning, executing, monitoring and closing observational/non-interventional studies. The CSM role will direct the financial and operational aspects of the project, including acting as the primary liaison to clients, project team and vendors to ensure optimal quality, efficiency and communication. The CSM is responsible for the planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring, of assigned project(s) to ensure delivery within specified budgets and timelines in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific instructions. As a leader you will drive your projects forward, proactively, identifying and mitigating risks along the way. Job Responsibilities: * Responsible for executing Tempus's observational trials in compliance with quality standards (ICH/GCP, Global Regulations, and Tempus policies and procedures) * Act as primary point of contact for clients. Anticipate client needs and proactively resolve issues as necessary * Lead cross-functional teams and third parties/vendors to ensure effective teamwork and communication * Manage project deliverables including timeline, quality, scope, and cost * Maintain study management system(s) * Develop and maintain project plans * Primary contact for assigned sites and build positive relationships with investigators and site staff * Complete monitoring visits and/or oversee Clinical Research Associates, as applicable * Manage participant recruitment, sample reconciliation, data entry to safe-guard project endpoints * Responsible for the completeness and quality of the Trial Master File * Provide temporary coverage/back-up for additional observational studies as required * May involve overnight travel Demonstration of Tempus Compass Values: Consistently strives to demonstrate the following Tempus Compass values: * Recognizes that the team is always stronger than the individual * Seeks to inspire others by demonstrating consistently strong performance * Treats people with respect regardless of role or point of view * Listens well and seek to understand before reacting * Provides candid, helpful and timely feedback to colleagues * Demonstrates curiosity about and contributes effectively to areas outside of their specialty * Keeps the bigger picture in mind when making decisions * Never stops learning * Questions assumptions and offers suggestions for improvement * Focuses on results rather than process and seeks to minimize complexity when process is required * Identifies and addresses root causes, not symptoms * Demonstrates poise in stressful situations * Strives to always do the right thing * Questions actions that are incongruent with Tempus Compass values Minimum Qualifications: * University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. * Minimum of five+ (5) years relevant clinical research experience in a combination of research site, life sciences company or CRO * Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. * Demonstrated ability to handle multiple competing priorities and to utilize resources effectively. * Demonstrated ability to be self-directed. * Working knowledge of project finance. * Familiar with concepts commonly incorporated non-therapeutic studies: risk-based monitoring, quality of life and patient-reported outcomes, health outcomes etc. * Excellent communication, planning and organizational skills. Preferred Qualifications: * Experience with observational/non-interventional studies, registries, comparative effectiveness studies, etc. * Prior experience working for both a sponsor/life science company and a CRO * Previous clinical monitoring experience #LI-SH1 #LI-Hybrid Pay Range: $76,000 - $105,000 The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Mid-Level Associate - Trial and Defense - Miami (must be admitted to the Bar in Florida & NY) Our Miami office is seeking a Mid-Level Litigation Attorney to work with our practice focused on the defense of complex product liability matters (environmental, asbestos, talc, etc.) and commercial disputes, working with product manufacturers, suppliers and insurers in relation to other long-tail and other general liability matters. Responsibilities You'll gain experience in: Taking depositions, attending hearings, and mediations as required; Drafting pleadings and briefs; Preparing correspondence to colleagues and clients; Conducting legal research using Westlaw/Lexis/Nexis; Drafting interrogatories and document demands; Reviewing document collections in preparation for litigation; Submitting filings to the court. Education and Experience J.D./LLM; Admission to practice in Florida and New York is required; 2-5 years law firm experience required; Commercial litigation experience is preferred but not required; Environmental/toxic tort experience is preferred but not required; Courtroom experience including motions is preferred but not required; Skills and Ability Exceptional legal writing and communication skills; Strong interpersonal skills: Ability to manage and prioritize multiple projects; Ability to identify and resolve problems quickly. Our Values Our values are the principles that guide the decisions we make, unite us in our endeavors and strengthen our delivery, for our clients and our firm. We: Work as one - We are a globally connected team of talented people who act with a firm-first mentality to achieve success Excel with clients - We aim high and challenge ourselves to deliver unique excellence for our clients, keeping them at the center of everything we do Celebrate difference - We help each other to be at our best and believe our differences result in greater achievement Act boldly - We seek new opportunities, take action and learn as we go, recognizing that curiosity drives our development and contributes to growth Benefits offered include student loan reimbursement; flexible time off; medical, dental, and vision insurance; 401K Safe Harbor contribution; Life/AD&D Disability; Flexible Spending Account; Supplemental Medical Accident Insurance; Supplemental Critical Illness Insurance; Employee Assistance Program; Pet Insurance; Commuter Benefits. We offer a rewarding work environment that supports professional growth and opportunities. We value diversity in our workplace and it is the policy of the Firm to recruit, hire, promote, reassign, compensate and train highly qualified persons without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, age, disability or any other basis protected by applicable law. When you work at Clyde & Co, you join a team of 500 partners, 2,400 lawyers, 3,200 legal professionals and 5,500 people in nearly 70 offices and associated offices worldwide. Our values are the principles that guide the decisions we make, unite us in our endeavours and strengthen our delivery, for both our clients and our firm. We work as one, excel with clients, celebrate difference and act boldly. We are committed to operating in a responsible way by progressing towards a diverse and inclusive workforce that reflects the communities and clients it serves. We are devoted to providing an environment in which everyone can realise their potential, using its legal and professional skills to support its communities. We do this through pro bono work, volunteering and charitable partnerships, and minimising the impact it has on the environment, including through our commitment to the SBTi Net-Zero standard and the setting of ambitious emissions reduction targets. We offer a range of tailored benefits and support, including healthcare, retirement planning and wellbeing initiatives. Clyde & Co is proud to be an equal opportunities employer. Our core values encourage us to support fairness, celebrate diversity and prohibit all forms of discrimination in the workplace to allow everyone to excel at work. Therefore, we welcome and encourage all applications from suitably qualified individuals, regardless of background or identity. Please take a moment to read our privacy notice carefully. This describes what personal information Clyde & Co (we) may hold about you, what it's used for, how it's obtained, your rights and how to contact us as a data subject. If you are submitting a candidate as a Recruitment Agency Partner, it is an essential requirement and your responsibility to ensure that candidates applying to Clyde & Co are aware of this privacy notice.

Clinic: Skin And Cancer Associates Join a thriving dermatology practice in Aventura, FL with Skin and Cancer Associates! We're looking for a General Dermatologist with interest in doing Clinical Research to join our friendly, highly trained team dedicated to clinical excellence and an outstanding patient experience. Why Join Us? Flexible Schedule - Achieve work-life balance while pursuing your passion. Diverse Cases - Provide both general and cosmetic dermatology services. Advanced Technology - Practice with autonomy using the latest equipment. Strong Community Ties - Benefit from our trusted reputation and active referral network. Practice Autonomy - Build your desired practice mix (General Dermatology, Surgical, and Cosmetics) Compensation & Benefits Competitive Compensation Structure - Guaranteed first-year salary or Personal Net Collections (the greater of) Dermatologist Salary Range: $400,000-$500,000 Partnership & Shareholder Track - Grow your career with ownership opportunities. Comprehensive Benefits - Medical, dental, vision, 401(k), PTO, and paid CME. Flexible Schedules - Designed to fit your lifestyle and a great work-life balance. Full-time (4 or more days per week schedules) Relocation Reimbursement Commencement Bonus Paid Malpractice and Tail Coverage Who We're Looking For Board-Certified or Board-Eligible Dermatologist Interested in learning Clinical Research Passionate about patient care and clinical excellence About SCA Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) is one of the premier dermatology groups in the United States. We are comprised of 80 Dermatologists, Nurse Practitioner's and Physician's Assistants at over 30 locations in Florida. All the physicians in the group are Board Certified Dermatologists, which means they have passed a rigorous examination proving their mastery of dermatology and its many component parts including dermatopathology. At SCA exceptional care of your skin is our top priority! We provide dermatology services for all conditions and diseases of the skin hair and nails. All of our medical staff is high-knowledgeable and expertly trained to provide excellent medical, cosmetic and surgical dermatologic care for both children and adults and for all skin types. We are also at the forefront of some of the most advanced dermatology research and clinical trials. Additionally, for your convenience, we offer telehealth services, via the Pocket Patient App. We invite you to review our dermatology services categorized below. Selecting any service will provide details for that service including service details, the physicians who offer the service as well as the location where the service is provided. About Platinum Dermatology Partners Platinum Dermatology Partners stands as a distinguished network of over 50 brands, encompassing 120 locations across Arizona, California, Florida, Nevada, and Texas, with more than 400 physicians and providers. We empower dermatologists to focus on what they do best - delivering outstanding clinical outcomes - by providing comprehensive business support, cutting-edge resources, and a collaborative community. Our unique partnership model preserves the individuality of each practice while offering the benefits of a larger, supportive network. At Platinum Dermatology Partners, we're not just advancing dermatology; we're shaping its future by fostering an environment where physician leadership drives clinical decisions, and our expertise optimizes practice operations and growth. Ready to advance your career in dermatology? Apply today and become part of a team that's redefining exceptional skin care!

At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Overview The Senior Clinical Trial Manager (CTM) plays a key role in supporting Clinical Trial Teams (CTT) and ensuring smooth trial operations. CTMs may be assigned various tasks to support clinical trial planning, execution, and oversight of clinical trials to ensure they are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and clinical trial protocols. The CTM works cross-functionally with study teams, investigators, and vendors to ensure trial objectives are met on time and within budget. Senior Clinical Trial managers are expected to assume roles and responsibilities with more autonomy. Roles & Responsibilities Trial Planning and Oversight Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards. Review of protocol and protocol amendments Coordinate the development of and manage updates of the Trial Oversight Plan Review of the Investigator's Brochure from DevOps perspective Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions Review of Regulatory Green Light packages Review the Development Safety Update Report Develop the Global Master ICF Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities. Site Selection and Management Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments, aligning site readiness with trial timelines. Coordinate the review of country-specific informed consent forms with internal stakeholders Vendor Management and Oversight Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs, to ensure their expertise aligns with trial demands. Trial Execution and Monitoring Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance. Maintain relevant sections in Clinical Trial Management Systems and Tools Drive the Operational Data Base review for the trial Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively. Responsible for maintenance of the Clinical Trial Team issue log in collaboration with Global Clinical Trial Manager Support GCTM in assessing key performance indicators (KPIs) at the trial level and manage escalation procedures for internal and external stakeholders. Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed. Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout. For US based candidates, the proposed salary band for this position is as follows: $122,000.00---$183,000.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! As an Associate Research Coordinator, one will assist the research coordinator (CRC/CCRC) in conducting clinical trials. The associate research coordinator is responsible for collecting, processing, storing and handling clinical specimens (as needed), scheduling study subjects for study visits, and collecting, recording, and filing clinical research data. Additionally, the associate research coordinator conducts study visits under the supervision of a study coordinator or senior coordinator. QPS' Story: Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of services, including Early Phase Clinical and Phase II - IV Clinical Research services. The QPS location in Miami, Florida is a multi-specialty research center employing clinical research professionals, including board-certified physicians, in a 32,000 square foot space. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life. Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals. If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website (************ for more information and to see all current openings. The Job Ensuring GCP is followed throughout the entire study conduct. Ensuring subject confidentiality. Ensuring the subject or subject's legal representative is provided with a copy of the signed and dated informed consent form. Possess a sound and in-depth understanding of each protocol that has been assigned Source document creation per Protocol requirements (if applicable) or as needed Ensuring compliance with applicable MRA SOP's/MRA Clinical Research SOP's, Good Clinical Practice guidelines and regulations Timely communication of study issues to the study coordinator Screening, Enrollment, and Ongoing Study Procedures Establish good rapport with potential study subjects Conduct telephone screening process Conduct Informed Consent Process (must complete Consenting Process module and quiz prior to consenting) Clinical data collection such as vital signs, ECG recording, subject height and weight, etc. Medical records retrieval and review Laboratory specimen collection, processing and shipment (as needed) Transporting clinical specimens to the laboratory Study visits scheduling Requirements Combination of relevant education & experience that provides sufficient knowledge & skills to ensure incumbent's success in this role, such as: High School Diploma, and/or Experience in a similar role Prior experience as a medical assistant or in an ancillary or allied health specialty a plus Why You Should Apply Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals. Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance. Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance QPS is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.

The Neurointerventional Surgery Research & Fellowship Coordinator is responsible for the comprehensive coordination of research studies and fellowship program administration within the Neurointerventional Surgery division. This hybrid position ensures compliance with clinical research protocols, regulatory requirements, and institutional policies, while also managing the operational and educational needs of the Neurointerventional Surgery Fellowship. The role serves as a primary liaison among faculty, fellows, research sponsors, hospital administration, and regulatory agencies to support excellence in patient care, research, and graduate medical education. Essential Duties and Responsibilities Research Coordination Coordinate all aspects of clinical trials and research projects within the Neurointerventional Surgery division. Recruit, consent, and enroll study participants in compliance with IRB, FDA, and sponsor requirements. Prepare, submit, and maintain IRB applications, amendments, and continuing reviews. Collect, document, and report research data accurately and in a timely manner. Maintain regulatory binders, study documentation, and source records in accordance with GCP guidelines. Serve as liaison with sponsors, CROs, auditors, and institutional research offices. Assist with abstract submissions, manuscripts, and presentations. Fellowship Coordination Oversee daily administration of the Neurointerventional Surgery Fellowship Program. Coordinate recruitment, onboarding, and orientation of fellows. Maintain program schedules, including clinical rotations, didactics, conferences, and call schedules. Track and report fellow case logs, evaluations, and compliance with institutional and accreditation standards. Ensure program adherence to ACGME and institutional requirements. Serve as primary point of contact for fellows, faculty, and Graduate Medical Education (GME) staff. Organize educational activities, program events, and fellowship graduation.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Assistant for the Future of Medicine program is an entry-level clinical position designed to fully integrate individuals into the Care Access research process. The Future of Medicine program brings clinical trials directly into communities, making research more accessible and inclusive for diverse populations. As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at regional events (with travel up to 25%). This role offers opportunities for growth and advancement within the Care Access Research organization. How You'll Make An Impact * As a Clinical Research Assistant, you'll support every stage of the research process: engaging with participants and collecting biospecimens, to managing data and maintaining regulatory compliance. You'll help bring clinical trials directly into local communities by supporting recruitment, outreach, and event operations. Along the way, you'll gain hands-on experience in clinical research with opportunities to grow your skills and career. * Clinical & Participant Care * Perform independent venipuncture, including managing difficult draws and re-attempts per protocol. * Collect, label, process, package, and ship biospecimens while maintaining chain of custody and temperature controls. * Obtain informed consent under the direction of the Clinical Research Coordinator (CRC). * Complete protocol-required visit procedures under CRC direction. * Communicate clearly with participants and on-site teams; escalate issues promptly. * Maintain effective, professional relationships with participants, investigators, and sponsor representatives. * Study Operations & Data Management * Record and enter data in real time on paper or e-source documents, ensuring accuracy and legibility. * Request and manage medical records for potential and current participants. * Update study trackers, online recruitment systems, and site logs. * Request and issue study participant payments. * Maintain adherence to FDA regulations, ICH guidelines, and institutional SOPs. * Member Education & Community Engagement * Participate in member education and pre-screening events, which may occur at multiple locations. * Set up and tear down event sites; prepare kits and supplies, ensuring aseptic technique and biohazard safety. * Assist with distribution of outreach and education materials. * Schedule participant visits and provide reminders. * Clinical Site & Administrative Support * Assist with administrative tasks such as copying, scanning, filing, mailing, and emailing. * Support inventory management and ordering of equipment and supplies. * Contribute to maintaining an organized, compliant site environment. * Other Responsibilities * Communicate clearly in both verbal and written form. * Perform other duties as assigned in support of study success. The Expertise Required * Technical & Operational Proficiency * Comfortable using eSource/mobile apps and standard office tools. * Proficiency in Microsoft Office Suite. * Ability to learn and adapt in a fast-paced, evolving environment. * Strong organizational skills with close attention to detail. * Professional & Interpersonal Skills * Excellent verbal and written communication skills with a high degree of professionalism across diverse groups. * Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. * Critical thinker and problem solver with strong initiative. * Ability and willingness to work independently with minimal supervision while contributing effectively to team and site goals. * High level of self-motivation, energy, and an optimistic "can do" attitude. Certifications/Licenses, Education, and Experience: * Clinical Skills & Experience * 1+ year of recent, hands-on phlebotomy experience in a clinical setting (≥200 venipunctures; ≥25-50 capillary sticks; ≥30-50 in the last 2-3 months). * Demonstrated competency in specimen processing. * Working knowledge of medical and research terminology, ICH-GCP, HIPAA/PHI handling, and related federal regulations. * Some prior clinical research experience preferred. * Current national phlebotomy certification, such as: * ASCP Phlebotomy Technician (PBT) * AMT Registered Phlebotomy Technician (RPT) * NHA Certified Phlebotomy Technician (CPT) * NCCT National Certified Phlebotomy Technician (NCPT) * State-specific licensure/certification if required (CA, WA, LA, NV). How We Work Together * Location: This position is for a full-time, hourly role. The standard schedule is Tuesday through Saturday, averaging 32-42 hours per week. Work is typically split between community events and a local clinical site (for example, a Houston-based team member may spend three days at community events and two days at the local site) * Travel: As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at national events (with travel up to 25%). The expected salary range for this role is $19.00-$33.00 USD per hour. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet. The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth campus in Miami, Fl. CORE JOB SUMMARY The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel. CORE JOB FUNCTIONS 1. Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility. 2. Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols. 3. Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations. 4. Maintains study binders and filings according to protocol requirements, UM and department policy. 5. Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator. 6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. 7. Assists in implementing protocol amendments under direct supervision of the Principal Investigator. 8. Assists with study orientation and protocol related in-services to research team and clinical staff. 9. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule. 10. Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators' academic administrative personnel, and departments. 11. Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews. 12. Adheres to cultural competency guidelines; implements strategies to meet study participants' needs for language translation, health literacy, etc. 13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. 14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. 15. Adheres to University and unit-level policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: Bachelor's degree in relevant field required Experience: Minimum 2 years of relevant experience required Knowledge, Skills and Abilities: * Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands. * Teamwork: Ability to work collaboratively with others and contribute to a team environment. * Technical Proficiency: Skilled in using office software, technology, and relevant computer applications. * Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Full time Employee Type: Staff

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager. In this job you will: Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution. Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time. Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria. Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff. Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed. Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment. Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual. Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution. Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments. Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions. Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding. Assist site staff with maintaining appropriate temperature monitoring for study products and supplies. Support the contract and budget negotiations and oversees Investigator/Site Payments. Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation. Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc. Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections. Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs). May be involved in the on-site training of additional staff as part of the SEO or other education programs. Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements. Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II. SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope. Qualifications Education Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects. Language Requirements Bilingual proficiency in English and Spanish is required. Certifications Current Good Clinical Practice (GCP) International Air Transport Association (IATA) Current Basic Cardiopulmonary Resuscitation (CPR) Phlebotomy certification unless part of active professional licensure (RN or LPN) Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified. Additional Information Located in Coral Springs, Florida. (On-site position). If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Bilingual Clinical Research Coordinators at our Little Havana, Miami location! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8 AM - 4:30 PM (occasional weekends) Location: 2128 W Flagler St 1st Floor, Miami, FL 33135 Compensation: Competitive hourly base compensation Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management. QUALIFICATIONS Bachelor's degree preferred, but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred Preferably 2+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

Who We Are: Platinum Dermatology Partners is a network of high-quality dermatology clinics that focus on collaborative and innovative ideas to drive growth. We offer general dermatology, cosmetic, medical, plastic surgery, and cancer screening treatments. We have over 145 clinics, over 350 providers, and more than 2300 employees in clinics across Texas, Arizona, California, Nevada, and Florida. We are a rapidly growing company that allows our doctors to focus on providing exceptional care without worrying about the operational side of the business. Our core values focus on collaboration, ownership, respect, excellence, authenticity, and integrity. Our purpose is to empower the practice of exceptional dermatology. Company Conformance Statements: In the performance of their respective tasks and duties, all employees are expected to conform to the following: Perform quality work within deadlines with or without direct supervision. Interact professionally with other employees, customers, and suppliers. Work effectively as a team contributor on all assignments. Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations. Job Summary: This role is responsible for perfoming all administrative aspects of clinical trial research studies based upon needs and goals of the Research Program. Tasks include, but are not limited to, recruitment completion of database logs for pre-screens, scheduling, consents, and close out of study per protocols. Provide support to PI/sub-I as requested at multiple clinics. THIS IS AN IN-CLINIC POSITION FOR AVENTURA, FLORIDA. Responsibilites: Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study including, but not limited to: Subject recruitment, screening and enrollment Collection of laboratory specimens, informed consent and other data from subject. Maintenance of source documents including CRF (case report form) completion and review for accuracy Participation in site monitoring visits and audits. Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos. Filing and maintenance of all study related documents. Documents adverse events and notifies principal investigator and appropriate agencies. Notifies Director, sponsor and IRB of any serious adverse events. Assist physician with all procedures to include excisions, injections, laser treatments, wound care, post-op care and dressing changes. Set up exam room for specific procedure as indicated. Provide patient education and literature. Take pre- and post-treatment pictures. Clean pack and sterilize instruments. Assists in cleaning rooms. Monitor physician's schedule to maintain timely flow. Ensure studies are conducted according to protocol and in accordance with GCP, ICH and FDA guidelines. Ensure IRB guideline and SOP compliance. Ensure all study timelines are met and study folders are kept updated and accurate. Work closely with the physician(s) and medical provider(s) assigned to the study. Oversee, participate and enter in timely manner data entry, perform study monitoring in peer-to-peer inter- rated methodology. Enter all data within 2 days of study visit by Research Coordinators and query resolution performed within 2 days of query. Random QC monitoring process to be established by Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology. Perform other tasks/duties as requested or assigned by PI/sub-I and Director. Must be able to travel to oversee studies in multiple sites as required. Coordinate study schedules with practice personnel. Train other team members on study protocols and visits. Qualifications Education: Bachelor's Degree required. Health Sciences background preferred. 3 years prior experience; knowledge of phlebotomy techniques Knowledge of IRB regulatory submission process, GCPs, and CFR related to research. Certified Clinical Research Coordinator (CCRC) designation a plus. Essential Skills and Abilities: Committed to executing exceptional patient service and satisfaction. Ability to support the organization's preferences and priorities. Ability to generate respect and trust from colleagues and leadership. Excellent listening, oral and written communication skills. Tactful, mature and able to interact well with diverse personalities. Able to exemplify professional behavior in all aspects of position. Computer literate with good keyboarding skills Ability to operate basic office equipment such as a phone, fax, copier, printer etc. Must have a valid driver's license. Our competitive benefits package includes the following: Medical, Dental, and Vision insurance Short-term/Long-term disability Life and other voluntary plans 401(k) plan Employee Referral Program Paid Time-Off Company-Paid Holidays Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc. Physical Requirements: Must possess manual dexterity to operate office machines including computer and calculator; stooping and bending to handle files and supplies; and mobility to complete errands or deliveries. Includes handling of sharps and chemicals. Equal Employment Opportunity: Platinum Dermatology Partners is committed to a policy of equal employment opportunities for applicants and Employees. Employment decisions will comply with all applicable laws prohibiting discrimination in employment, including Title VII of the Civil Rights Act of 1964, The Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Immigration and Nationality Act, the California Fair Employment and Housing Act, and all other applicable state and federal laws. Platinum Dermatology Partners does not permit discrimination of any type against an employee because of any of the following legally protected characteristics: gender, race, color, religion, country of origin, mental disability, physical disability, marital status, gender identity, gender expression, ancestry, genetic information, medical condition, age, sexual orientation, or pregnancy. Please note, that any offer of employment is contingent on the successful completion of pre-employment background checks. No phone calls or agencies, please.

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.

Department: Jackson Memorial Hospital - Revenue Cycle Management Shift details: Full-Time, Mon-Fri, 9am-5:30pm Why Jackson: Jackson Health System is a nationally and internationally recognized academic medical system offering world-class care to any person who walks through our doors. For more than 100 years, Jackson has evolved into one of the world's top medical providers for all levels of care, no matter if it's for a routine patient visit or for a lifesaving procedure. With more than 2,000 licensed beds, we are also proud of our role as the primary teaching hospital for the University of Miami Miller School of Medicine. Here, the best people come together to deliver Jackson's mission for our diverse communities. Our employees are committed to providing the best CARE by demonstrating compassion, accountability, respect, and expertise in everything we do. Summary Clinical Denials Coordinator is responsible for back up coverage within the entire Utilization Review team within Revenue Cycle which includes: Utilization Review within the (Emergency Dept area, Inpatient Utilization Review area, and all workflows within the Central Clearance Center functions as needed. Clinical Denials Coordinators are also responsible for reviewing denied accounts, establishing trends, identifying operational improvement opportunities, working with the impact areas to correct and improve weaknesses within their processes that leads to denials. Audit accounts as needed, and address clinical issues leading to denials. Work with payors on focused audits and coordinate the clinical audits. Work closely with the denial agencies on reporting and placements. Work with Utilization leadership on any assigned team projects. Responsibilities Audit denied or potentially denied accounts to determine true denial reason. Collaborate with denial agencies on identifying trends and reporting to denial committees. Work closely with payors and JHS managed care department and manage projects focused on resolving denials and improving recoveries. Coordinate denial committee meetings at each facility and ensure reviews and reports are completed timely and presented at each meeting. Assist the CBO in reconciling placements and recoveries monthly to ensure Siemens and Connance are in balance. Coordinate with CFO's and denial committee teams at each facility to ensure net denial targets are met. Crosstrain and assist with invoice reconciliation as needed. Assist with internal and external audit requests relating to denials as requested by management. Performs other related duties as assigned. Experience * Generally requires 3 to 5 years of related experience. * Preferred past payer experience specifically with utilization review, denials, audits, and/or appeals. Education * Bachelor's in Science required with a certification as a PA, LPN or RN. * Master's degree preferred and/or certification as ARNP or Foreign Medical Graduate. Credentials Valid PA, LPN or RN is preferred. Jackson Health System is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law.

About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. About the Role: We are seeking a highly motivated PRN Research Assistant (RA) to join our team at CPMI in Miami, FL. As a PRN RA, you will be responsible for assisting with research studies, collecting and analyzing data, and ensuring compliance with study protocols. The Research Assistant will ensure compliance with protocol and overall clinical objectives. In executing these position responsibilities, the Research Assistant is guided FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. Responsibilities: Assist with research studies by collecting and analyzing data Ensure compliance with study protocols and regulations Maintain accurate and complete records of research activities Prepare source documents for study visits. Perform vitals, ECGs, and phlebotomy. Data Entry from patient visit Manage lab kit inventory. Ship and process specimens Undertake protocol trainings as assigned. General office tasks such as filing, copying, and scanning. Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives. Minimum Qualifications: High School Diploma or its equivalent; College degree preferred. 1 year of clinical experience is preferred. Strong organizational and communication skills Ability to work independently and as part of a team Attention to detail and accuracy Preferred Qualifications: Experience with clinical research studies Knowledge of regulatory requirements for research studies Knowledgeable in medical terminology Benefits Overview: Our comprehensive benefits package includes: Health insurance Dental & Vision Insurance Matching 401k Retirement Plan Paid Time Off (PTO)

The Clinical Research Medical Assistant Assistant assists with the execution of new studies and the maintenance of open and closed studies, performing administrative and clinical tasks for trials. This position works in close collaboration with Clinical Research Coordinators, other Research Assistants, sponsors, and compliance to carry out responsibilities per the study protocol. Duties/Responsibilities: Assists the Principal Investigator (PI) and other research staff to ensure clinical research and related activities are performed in accordance with federal regulation and Rovia SOPs. Performs clinical tasks like lab processing, phlebotomy, diagnostic tests, drug accountability, and vital signs, where appropriate and as delegated by the PI, in accordance with local requirements and licensures. Maintains the documentation of appropriate and necessary training for research staff on the study-specific training log. Cooperates with Rovia compliance and monitoring efforts, reporting instances of noncompliance to the Rovia Clinical Operations and Compliance departments. Attends and participates in investigator meetings, monitoring visits, audits, seminars, and other regional or national meetings as required. Collects study documents needed to initiate the study and submit to the sponsor. Organizes and maintains filing in all study documentation, including regulatory binders, study-specific source documentation, and other materials. Develops a working familiar with study protocol, including study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections. Supports site documentation, including but not limited to submission of data into the Electronic Data Capture system, source documentation, case report forms, Dear Doctor letters, and consent forms. Schedules study participant appointments and serves as the patient liaison to the PI and other investigators, which may include performing study visit reminder phone calls and registering subjects to the appropriate coordinating center. Maintains adequate inventory of study supplies and follows the sponsor protocol and Rovia SOPs on Investigational Product Accountability. Registers subject visits in the Rovia Clinical Trial Management System in a timely manner to ensure appropriate billing of study procedures. May perform other job-related duties as requested or required. Required Skills/Abilities: Sound knowledge of medical terminology. Sound knowledge of ICH/GCP and Regulatory requirements. Knowledge of Good Clinical Practice (GCP) and FDA and HIPAA policies and practices. Excellent interpersonal skills to work effectively with colleagues, clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors. Strong organizational skills. Proficient in the use of Microsoft Office and Excel. Fluent in spoken and written Spanish and English. Ability to work independently, prioritize actively, seek input, solve problems, and work in a team environment. Meticulous attention to detail. Ability to maintain confidentiality. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Education and Experience: High school diploma required. Phlebotomy or Medical Assistant certification or experience, as required by county authorities to perform clinical tasks. Current GCP and IATA certification preferred or must be obtained upon hire.