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Clinical Research Coordinator jobs at Danbury Hospital - 318 jobs

  • Clinical Trial Associate

    Axsome Therapeutics, Inc. 3.6company rating

    New York, NY jobs

    Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Clinical Trial Associate (CTA) that is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role provides support to the Clinical Trial Manager (CTM), field based Clinical Research Associates (CRAs), and clinical study sites. This role will be a key study team member responsible for contributing to the life cycle of a clinical trial (all phases) and assure compliance with SOPs, FDA regulations, and ICH/GCP guidelines. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Create and maintain study trackers (e.g., contact lists, study status trackers, study specific checklists.) Ensure accurate and up to date information in clinical trial management system (CTMS) Review and maintain documents in the Electronic Trial Master File (eTMF) Assist clinical study team during all phases of clinical trial activities (e.g., feasibility, start-up, maintenance, and close-out) Collect and review clinical study site essential regulatory documents prior to site initiation/study drug release Submission and tracking of documents to central/local Institutional Review Board (IRB) Distribute study materials to clinical study sites, as directed Participate in meetings with internal and external stakeholders, draft meeting agendas and minutes, as needed Assist the clinical study team in preparation and distribution of study documents and materials (e.g., informed consent form, regulatory binder, patient recruitment materials, and newsletters) Support field-based CRAs Assist data management with review of clinical data as needed Assist clinical study team with the final reconciliation of the eTMF during study close-out Requirements / Qualifications Bachelor's degree required. Preference to candidates with a life science degree Minimum 6 months - 1 year of relevant experience Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles. Experience and Knowledge Must have good organizational skills, be a team player, function independently, and be able to interact comfortably with colleagues and external stakeholders (e.g., study vendors, clinical study sites). Basic understanding of ICH/GCP and clinical research terminology preferred Comfortable multi-tasking in a fast-paced small company environment and able to adjust priorities as needed Excellent team player; willingness and ability to fill functional gaps in a small but growing organization Additional skills/qualifications for the role, including any that are preferred but not required Salary & Benefits The anticipated salary range for this role is $60,000 - $66,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
    $60k-66k yearly 5d ago
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  • Clinical Trial Operations, Senior Clinical Trial Associate/Clinical Trial Associate

    Anavex Life Sciences Corp 2.8company rating

    New York, NY jobs

    If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas. Senior Clinical Trial Associate/Clinical Trial Associate Apply Summary of Position Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. Set up and maintain study-specific paper and electronic TMFs. Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. Process essential documents and ensure they are correctly filed in the appropriate TMF. Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. Participate in GxP audits and related clinical operations compliance and inspection readiness activities. Prepare and track study documents (e.g., contracts, budgets, IRB documentation). Assist with information gathering, literature searches, and creation of presentations, as needed. Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) Administer user access and change control within Anavex's electronic systems. Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. Assist with vendor management and associated logistics, as assigned. Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements BS/BA in Life Sciences or equivalent 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. Familiar with the DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox Strong critical thinking, organizational and time-management skills Ability and willingness to travel (up to 10% of the time) Your Path to Unique Opportunities If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at ************** . EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Stay Connected Follow us on social media Letter from the CEO Our Values Contact Us
    $79k-131k yearly est. 8d ago
  • Clinical Trial Operations, Senior Clinical Trial Associate/Clinical Trial Associate

    Anavex 2.8company rating

    New York, NY jobs

    Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities * Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. * Set up and maintain study-specific paper and electronic TMFs. * Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. * Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. * Process essential documents and ensure they are correctly filed in the appropriate TMF. * Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. * Participate in GxP audits and related clinical operations compliance and inspection readiness activities. * Prepare and track study documents (e.g., contracts, budgets, IRB documentation). * Assist with information gathering, literature searches, and creation of presentations, as needed. * Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) * Administer user access and change control within Anavex's electronic systems. * Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. * Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. * Assist with vendor management and associated logistics, as assigned. * Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. * Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. * Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) * Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. * Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. * Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. * Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. * Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements * BS/BA in Life Sciences or equivalent * 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment * Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. * Familiar with the DIA reference model * Knowledge of ICH/GCP and applicable regulations * Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) * Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines * Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox * Strong critical thinking, organizational and time-management skills * Ability and willingness to travel (up to 10% of the time)
    $79k-131k yearly est. 8d ago
  • Clinical Research Coordinator - Part Time

    Bethany Medical Clinic 4.2company rating

    New York, NY jobs

    About the Job Job Title: Certified Clinical Research Coordinator (CCRC) Part-Time | One Day per Week (On-Site) 222 East 31st street, second floor, New. York, NY 10016 We are seeking a Certified Clinical Research Coordinator (CCRC) to join our growing clinical research site on a part-time basis (one day per week). This role is ideal for an experienced coordinator who values high-quality research, operational excellence, and schedule flexibility. The CCRC will play a critical role in ensuring the ethical, regulatory, and operational integrity of clinical trials while supporting investigators, participants, and sponsors in a highly organized and patient-centered environment. Key Responsibilities: Coordinate and manage assigned clinical trials in compliance with GCP, ICH, FDA regulations, and IRB requirements. Serve as the primary point of contact for study participants, investigators, sponsors, and CROs on assigned study days. Conduct study visits, including participant screening, informed consent, visit coordination, and protocol-specified procedures. Ensure accurate, timely, and complete documentation in source documents, EDC systems, and regulatory binders. Support monitoring visits, audits, and inspections, ensuring readiness and responsiveness. Maintain study supplies, investigational product accountability, and specimen handling per protocol. Collaborate closely with the Principal Investigator and research leadership to support study success. Qualifications: Certified Clinical Research Coordinator (CCRC) required. Minimum 2+ years of hands-on clinical research coordination experience. Strong working knowledge of GCP, ICH, FDA regulations, and IRB processes. Experience working directly with sponsors, CROs, and monitors. Excellent organizational skills with high attention to detail. Professional, patient-centered communication style. Ability to work independently and efficiently in a focused, one-day-per-week role. Preferred Experience: Experience in industry-sponsored clinical trials. Familiarity with EDC platforms (e.g., Medidata, REDCap, Veeva, or similar). Experience across multiple therapeutic areas (not required). Schedule & Commitment: One consistent day per week (on-site). Ideal for professionals seeking: Supplemental income. Portfolio or semi-retired work. Balance alongside another research or clinical role. What We Offer: Competitive hourly compensation commensurate with experience. A highly organized, collaborative, and respectful research environment. The opportunity to contribute meaningfully to clinical research without a full-time commitment. Stable, predictable schedule with minimal administrative burden. How to Apply Please submit your CV and a brief cover note highlighting your clinical research experience and availability. AboutBethany Medical Clinic About Bethany Medical Clinic of New York:At Bethany Medical Clinic, we value our patients' time and busy schedules. That is why we offer early morning and after work hour appointments at our conveniently located Murray Hill office in New York City. Our goal is to keep waiting time to a minimum and maximize our high level of expertise in an efficient manner during your appointment. You can expect a personalized, non-corporate approach and compassionate care. We embrace the contemporary philosophy that primary care should be predictive, rather than reactive. We not only listen to our patients, but we help them shape their own healthcare journey. Visit our website at *************** for more information!
    $46k-68k yearly est. 8d ago
  • Senior Clinical Research Coordinator - Plant City, Florida

    Denali Health 3.8company rating

    Plant City, FL jobs

    Denali Health is seeking an experienced Senior Clinical Research Coordinator to join our dynamic research team. The Senior Clinical Research Coordinator will be responsible for overseeing the planning, coordination, and execution of clinical trials at our research site. The ideal candidate will have substantial experience in clinical research, strong leadership skills, and a deep understanding of regulatory requirements and study protocols. Key Responsibilities: Study Coordination & Execution: Oversee the day-to-day execution of clinical trials, ensuring that protocols, maintaining and improving standard operating procedures (SOPs), and regulatory guidelines are adhered to. Serve as a point of contact between the study sponsor, PI, and research team. Coordinate the activities of the clinical research staff to ensure successful and timely completion of study milestones. Participant Management: Screen, enroll, and consent study participants in accordance with study protocols. Ensure study participants' safety and well-being by monitoring adherence to study protocols and identifying and addressing adverse events or protocol deviations. Data Collection & Documentation: Collect, record, and manage clinical research data with accuracy and completeness in accordance with Good Clinical Practice (GCP) and sponsor requirements. Maintain comprehensive and organized records, including study logs, patient files, and study source documents. Regulatory Compliance & Reporting: Prepare and submit required regulatory documents, including IRB submissions, FDA forms, and protocol amendments. Ensure all study documentation is up-to-date, compliant with applicable regulations, and audit-ready. Collaborate with study monitors, auditors, and other external reviewers to facilitate study reviews and inspections. Team Leadership & Training: Mentor and provide guidance to junior research coordinators and support staff, ensuring effective team performance. Train new staff on study-specific protocols, research regulations, and site SOPs. Communication & Collaboration: Liaise with study sponsors, vendors, and internal stakeholders to facilitate effective study management and communication. Lead study-related meetings, including study initiation, monitoring, and close-out visits. Qualifications: Education: Bachelor's degree in health sciences, nursing, or a related field. A Master's degree is p Minimum of 3 years of clinical research coordination experience. Experience in multiple therapeutic areas or complex clinical trials is an advantage. Certifications: Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred. Skills: Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial best practices. Strong leadership and project management skills. Excellent communication and interpersonal skills. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Why Join Denali Health? We offer a collaborative work environment focused on advancing clinical research and improving patient outcomes. Denali Health provides competitive compensation, career growth opportunities, and a culture dedicated to innovation and excellence. Apply now if you're ready to make a significant impact in clinical research and take on a leadership role.
    $63k-97k yearly est. 4d ago
  • Clinical Improvement Coordinator

    Adventhealth 4.7company rating

    Daytona Beach, FL jobs

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 301 MEMORIAL MEDICAL PKWY **City:** DAYTONA BEACH **State:** Florida **Postal Code:** 32117 **Job Description:** + Demonstrates bedside clinical skills and proficiency in EMR documentation. + Develops and executes unit-based staff education on new equipment, medication, policy and procedure changes, and advances in clinical practice. + Works with the Nurse Manager to facilitate successful onboarding of new staff. + Rounds on patients as directed by Nursing Director, providing feedback to nursing staff including coaching and guidance to improve patient safety and quality outcomes. + Provides coaching and guidance to individual nursing staff members to achieve improved performance and outcomes. **The expertise and experiences you'll need to succeed:** **QUALIFICATION REQUIREMENTS:** Bachelor's of NursingAdvanced Cardiac Life Support Cert (ACLS) - RQI Resuscitation Quality Improvement, Basic Life Support - CPR Cert (BLS) - RQI Resuscitation Quality Improvement, Registered Nurse (RN) - EV Accredited Issuing Body **Pay Range:** $31.82 - $59.17 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Risk Management, Quality, & Clinical Effectiveness **Organization:** AdventHealth Daytona Beach **Schedule:** Full time **Shift:** Day **Req ID:** 150660535
    $31.8-59.2 hourly 3d ago
  • Clinical Improvement Coordinator

    Adventhealth 4.7company rating

    Tavares, FL jobs

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 1000 WATERMAN WAY **City:** TAVARES **State:** Florida **Postal Code:** 32778 **Job Description:** **GENERAL SUMMARY:** The Clinical Improvement Coordinator is responsible for monitoring and impacting improvement in patient satisfaction. The Clinical Improvement Coordinator rounds on the care team and patients, monitors comments received, analyzes patient satisfaction survey scores, and facilitates patient experience training/presentations. Identifies opportunities for improving care or preventing events that have a negative impact on patient care. **PRINCIPAL DUTIES AND JOB RESPONSIBILITIES** **:** + Rounds on care team on a daily basis to observe quality of care delivered to patients and family and provides coaching/feedback to care team. + Rounds on patients on a daily basis to discuss the quality of care they are receiving and provides feedback to care team staff and nurse manager. + Works closely and communicates with clinical leaders from inpatient nursing, the Emergency Department and Surgical Services. + Facilitates use of survey data to develop proactive measures to improve patient satisfaction. + Is responsible for preparation of timely and accurate reports of data collected for the review activities listed above for presentation to members of the Medical Staff, Medical Staff committees, hospital committees, and/or Administration. + Creates and completes data reports for leaders on a weekly, monthly, and ad hoc basis to include, but not limited to: HCAHPS, ED CAHPS, and OAS CAHPS detail reports. + Monitors the above outcomes on a monthly basis and reports analyzed trends to leaders for monthly Pier Review Committees including action plans. + Presenter/educator for patient experience training/presentations involving entry level, clinical, and physician team members. + Oversees training and education schedule for AdventHealth Waterman Patient Experience. Manages educational requests received. + Completes and submits Origami to Risk Management for any grievances that may be received from time to time. + Performs other related duties as assigned or requested. **Knowledge, Skills, and Abilities:** - Computer skills with a proficiency in Microsoft Office and must be adaptable to new software programs. [Required] - Strong interpersonal skills [Required] **Education:** - Bachelor's of Nursing [Preferred] **Field of Study:** - Graduate of an approved school of nursing Required **Work Experience:** - 3+ years of clinical experience [Required] **Additional Information:** - N/A **Licenses and Certifications:** - Registered Nurse (RN) [Required] - Basic Life Support - CPR Cert (BLS) [Required] - Advanced Cardiac Life Support Cert (ACLS) [Required] **Physical Requirements:** _(Please click the link below to view work requirements)_ Physical Requirements - **************************** **Pay Range:** $31.82 - $59.17 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Risk Management, Quality, & Clinical Effectiveness **Organization:** AdventHealth Waterman **Schedule:** Full time **Shift:** Day **Req ID:** 150761848
    $31.8-59.2 hourly 3d ago
  • Physician Practice Clinic Coordinator

    Adventhealth 4.7company rating

    Tampa, FL jobs

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 3000 MEDICAL PARK DR **City:** TAMPA **State:** Florida **Postal Code:** 33613 **Job Description:** Shift: M-F FT 8-5 FT Performs other duties as assigned. Reviews charts proactively to identify gaps in care, insurance, orders, coding, and referrals. Completes weekly rounding activities and performs audits. Assists with patient experience improvements, clinical staff scheduling, education, and development conversations. Builds and maintains positive, effective relationships with all Physicians and APPs in their location. Assesses team members' clinical competency to complete tasks including but not limited to administering injections, drawing blood, rooming patients, and the like. Ensures workflow optimization and effectiveness for the team which includes Physicians, APPs, and staff. Assists daily with effective huddles (including Daily Management Boards) within the practice. Responsible for favorable results related throughput, patient experience, provider and staff satisfaction, and value based care. Completes operational processes that are focused on maximizing use of clinical space, ease of access to care, and patient flow. Manages patient care by reviewing Inbasket, schedules, radiology, and lab results, answering phones, and communicating with patients. Prepares next-day patient charts, ensuring all necessary information is available and communicated to doctors and front office staff. Assists physicians and advanced practice providers with medical equipment and procedures as needed. Maintains timely communication with patients regarding surgery, prescriptions, and testing. Ensures efficient patient work-up flow and triage responsibilities. Documents patient medications, messages, sample medications, and pharmacy information accurately and legibly. Stays current with new technology and updates on care and medications. Assists with prior authorizations, referrals, and procedural scheduling. Controls supplies and maintains inventory weekly. Precepts new clinical staff through skill validation. Demonstrates knowledge and compliance of Hospital guidelines and/or regulatory requirements. Contributes to the growth of the practice by managing patient flow and recommending follow-up visits if needed. Assists with Development Conversations for clinical staff. Attends POC meetings. Attend departmental meetings and stay up to date on all business initiatives related to the Practice. Completes Team Huddles to present current data and assist in action planning. **The expertise and experiences you'll need to succeed:** **QUALIFICATION REQUIREMENTS:** High School Grad or Equiv (Required), Technical/Vocational School (Required) Basic Life Support - CPR Cert (BLS) - RQI Resuscitation Quality Improvement, Certified Medical Assistant (CMA) - EV Accredited Issuing Body, Licensed Practical Nurse (LPN) - EV Accredited Issuing Body **Pay Range:** $20.38 - $32.60 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Medical Assistant & Technician Services **Organization:** AdventHealth Medical Group Support **Schedule:** Full time **Shift:** Day **Req ID:** 150659100
    $20.4-32.6 hourly 3d ago
  • Lung Transplant Clinical Coordinator

    Adventhealth 4.7company rating

    Orlando, FL jobs

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 601 E ROLLINS ST **City:** ORLANDO **State:** Florida **Postal Code:** 32803 **Job Description:** Coordinates pre-transplant evaluations and assessments. Manages the transplant waiting list and patient status updates. Facilitates communication between patients, families, and the transplant team. Organizes and schedules transplant surgeries and related procedures. Provides education and support to patients and families throughout the transplant process. Monitors post-transplant recovery and follow-up care. Manages donor organ procurement and transportation logistics. Communicates the schedule for stem cell collections/harvest with the dialysis department. Coordinates with the blood bank to facilitate designated donor and phereses blood products for the patient. Coordinates pre and post-bone marrow transplant evaluation for the patient and donor, when applicable. Develops and implements policies and procedures related to transplant coordination. Other duties as assigned. **The expertise and experiences you'll need to succeed:** **QUALIFICATION REQUIREMENTS:** Bachelor'sAdvanced Cardiac Life Support Cert (ACLS) - RQI Resuscitation Quality Improvement, Basic Life Support - CPR Cert (BLS) - RQI Resuscitation Quality Improvement, Registered Nurse (RN) - EV Accredited Issuing Body **Pay Range:** $72,189.82 - $134,259.75 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Surgery Services **Organization:** AdventHealth Orlando **Schedule:** Full time **Shift:** Day **Req ID:** 150658801
    $40k-65k yearly est. 3d ago
  • Non Certified Transplant Clinical Coordinator

    Adventhealth 4.7company rating

    Orlando, FL jobs

    Our promise to you: Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better. All the benefits and perks you need for you and your family: * Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance * Paid Time Off from Day One * 403-B Retirement Plan * 4 Weeks 100% Paid Parental Leave * Career Development * Whole Person Well-being Resources * Mental Health Resources and Support * Pet Benefits Schedule: Full time Shift: Day (United States of America) Address: 601 E ROLLINS ST City: ORLANDO State: Florida Postal Code: 32803 Job Description: Coordinates pre-transplant evaluations and assessments. Manages the transplant waiting list and patient status updates. Facilitates communication between patients, families, and the transplant team. Organizes and schedules transplant surgeries and related procedures. Provides education and support to patients and families throughout the transplant process. The expertise and experiences you'll need to succeed: QUALIFICATION REQUIREMENTS: Bachelor'sAdvanced Cardiac Life Support Cert (ACLS) - RQI Resuscitation Quality Improvement, Basic Life Support - CPR Cert (BLS) - RQI Resuscitation Quality Improvement, Registered Nurse (RN) - EV Accredited Issuing Body Pay Range: $72,189.82 - $134,259.75 This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
    $40k-65k yearly est. 4d ago
  • Non Certified Transplant Clinical Coordinator

    Adventhealth 4.7company rating

    Orlando, FL jobs

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 601 E ROLLINS ST **City:** ORLANDO **State:** Florida **Postal Code:** 32803 **Job Description:** + Coordinates pre-transplant evaluations and assessments. + Manages the transplant waiting list and patient status updates. + Facilitates communication between patients, families, and the transplant team. + Organizes and schedules transplant surgeries and related procedures. + Provides education and support to patients and families throughout the transplant process. **The expertise and experiences you'll need to succeed:** **QUALIFICATION REQUIREMENTS:** Bachelor'sAdvanced Cardiac Life Support Cert (ACLS) - RQI Resuscitation Quality Improvement, Basic Life Support - CPR Cert (BLS) - RQI Resuscitation Quality Improvement, Registered Nurse (RN) - EV Accredited Issuing Body **Pay Range:** $72,189.82 - $134,259.75 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Surgery Services **Organization:** AdventHealth Orlando **Schedule:** Full time **Shift:** Day **Req ID:** 150659956
    $40k-65k yearly est. 3d ago
  • Clinical Research, Clinical Research Associate (Remote)

    Castle Biosciences 3.7company rating

    Indianapolis, IN jobs

    Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at ************************* Castle Biosciences Inc. is growing, and we are seeking to hire a full-time Clinical Research Associate to work remotely from a home-based office in the USA, preferably located in the greater Chicago area, St. Louis, Missouri, Ohio, Virginia, Pennsylvania, Nashville, Indianapolis, or Atlanta within close proximity to a major airport. Why Castle Biosciences? * Exceptional Benefits Package: * Excellent Annual Salary + 20% Bonus Potential * 20 Accrued PTO Days Annually * 10 Paid Holidays * 401K with 100% Company Match up to 6% * 3 Health Care Plan Options + Company HSA Contribution * Company Stock Grant Upon Hire Salary Range: $90,000 - $95,000. Salary Range is based on Experience and Education levels. A DAY IN THE LIFE OF A Clinical Research Associate The Clinical Research Associate (CRA) is responsible for managing sites participating in Castle's clinical studies. Daily tasks vary based on study and site needs and may include attending team meetings, training site staff, sending emails, and traveling to U.S. sites to monitor data. The CRA performs all aspects of clinical monitoring and site management in compliance with ICH GCP, FDA guidelines, local regulations, protocols, and Castle's SOPs. This role ensures protocol and regulatory compliance, manages study documentation, and fosters strong relationships with sites. CRAs also play a key role in protecting participant safety, ensuring data quality, and representing Castle in the broader research community. REQUIREMENTS * Bachelor's degree in a science or healthcare-related field or a registered nursing certification, or equivalent certification/licensure from an appropriately accredited institution. * 3 years of CRC experience or previous 1 year experience as a CRA. * Direct patient care or clinical research experience required. * Familiarity with clinical research and study development processes. * Valid Driver's License where applicable. * In some cases, a combination of education, professional training, and demonstrated experience that provides the required knowledge, skills and abilities may be considered. TRAVEL/WORK ENVIRONMENT * Regular overnight travel by car and air, typically 50-60% of the time, with potential peaks up to 80% * Flexibility to accommodate an often changing and unpredictable timeline * Frequent laptop use * When in the office, there is a standard office environment with the use of a desk/phone/computer * Generally, proof of COVID-19 vaccination will be required to access study sites, in accordance with site-specific guidelines and subject to any applicable exceptions as required by Federal, State, and Local laws. SCHEDULE * M-F travel-based position; working remotely from your home based in the USA near a major airport. * Preferred locations include greater Chicago area, St. Louis MO, Ohio, Virginia, Pennsylvania, Nashville or Atlanta within close proximity to a major airport. READY TO JOIN OUR BIOTECH TEAM? We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon! Castle Biosciences Awards and Research Developments! WORK AUTHORIZATION All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas. ABOUT CASTLE BIOSCIENCES INC. At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development. Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com. This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. No third-party recruiters, please
    $90k-95k yearly 7d ago
  • Clinic Trials Support Specialist

    Maimonides Medical Center 4.7company rating

    New York, NY jobs

    About Us We're Maimonides Health, Brooklyn's largest healthcare system, serving over 250,000 patients each year through the system's 3 hospitals, 1800 physicians and healthcare professionals, more than 80 community-based practices and outpatient centers. At Maimonides Health, our core values H.E.A.R.T drives everything we do. We uphold and maintain Honesty, Empathy, Accountability, Respect, and Teamwork to empower our talented team, engage our respective communities and adhere to Planetree's philosophy of patient-centered care. The system is anchored by Maimonides Medical Center, one of the nation's largest independent teaching hospitals and home to centers of excellence in numerous specialties; Maimonides Midwood Community Hospital (formerly New York Community Hospital), a 130-bed adult medical-surgical hospital; and Maimonides Children's Hospital, Brooklyn's only children's hospital and only pediatric trauma center. Maimonides' clincal progams rank among the best in the country for patient outcomes, including its Heart and Vascular Institute, Neuroscience Institute, Boneand Joint Center, and Cancer Center. Maimonides is an affiliate of Northwell Health and a major clinical training site for SUNY Downstate College of Medicine. Overview The Clinic Trials Support Specialist responsible for coordinating and supporting the conduct of clinical research protocols and projects, with a primary focus on screening, enrolling, and monitoring patient participants. This role works closely with investigators, clinical teams, and research staff to ensure studies are conducted in accordance with approved protocols, regulatory requirements, and institutional policies while maintaining participant safety and data integrity. Responsibilities * Prepare, submit, and maintain IRB and regulatory documentation, including Trial Master File, delegation logs, regulatory binders, and essential study files * Screen, enroll, and consent participants in collaboration with the Principal Investigator, ensuring proper informed consent documentation * Educate study participants on protocol requirements and support completion of required study procedures and surveys * Coordinate participant visits, tests, and procedures; assist physicians during patient visits in accordance with study protocols * Monitor subject recruitment and study progress, report adverse events in RAVE following discussion with the Principal Investigator * Collect, process, and ship research specimens per protocol and IATA/DOT standards; manage study kit inventory, shipments, and data collection from electronic medical records, including timely database submission and query resolution Qualifications We require: * Bachelors of Science in Biology or Chemistry; Masters preferred. * 2+ years of research experience in the medical field or an advanced degree in a Biology or Chemistry required. * Good oral and written communication skills. * Good interpersonal and organizational skills. * Speaks, reads and writes English to the extent required by the position. * Ability to speak Chinese or Mandarin is a plus. Pay Range USD $66,779.00 - USD $66,779.00 /Yr. Equal Employment Opportunity Employer Maimonides Medical Center (MMC) is an equal opportunity employer.
    $66.8k yearly 15d ago
  • Study Coordinator

    Sarah Cannon Research Institute 3.6company rating

    Orlando, FL jobs

    It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process This position will be open for applications until February, 10 2026. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $43k-57k yearly est. Auto-Apply 19d ago
  • Senior Clinical Trial Specialist - Remote Position

    Puma Biotechnology, Inc. 4.3company rating

    South San Francisco, CA jobs

    The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote
    $90k-100k yearly 41d ago
  • Clinical Research Coordinator III - Emergency Medicine

    Emergency Medicine 4.9company rating

    Jacksonville, FL jobs

    The Clinical Research Coordinator III (CRC III) is responsible for the coordination of assigned research studies and educational programs funded by federal, industry and private foundation grants, in which the department is involved. Funded topics can include pain, opioid alternatives, EMS, sepsis, geospatial, biomarker, and precision medicine. The CRC III will perform functions necessary for successful completion of all protocols including but not limited to enrollment and follow up visits and procedures such as vital signs, phlebotomy, nasopharyngeal, saliva, and blood diagnostic tests, dispensing of investigational products, scheduling, drug accountability and reconciliation, sponsor site visits, regulatory and organizational tasks, where appropriate and as delegated by the investigator and Assistant Director of Clinical Research in the Department of Emergency Medicine. Reviews and follows research protocols to screen and enroll patients into IRB approved studies including specimen collections, laboratory processing and device education. Performs study follow-up visits including phlebotomy, vital signs, psychometric surveys, and dispensing of investigational products. Assists in developing study protocols and checklists; completes source document data and case report forms. Enters data into appropriate study databases and develops databases as needed. Ensures IRB and regulatory documents are properly filed in regulatory study binders and that binders are up to date for review by auditors and study monitors. Serves as a liaison between subject, investigators, IRB, sponsors and other relevant healthcare professionals who are part of the research or patient care project team for smooth and informed implementation of studies. Ensures that research participants are properly associated in EPIC collaborates and communicates with state/hospital/ED/pain clinic/pharmacy staff and other departments to ensure a team approach for completing research activities. Trains clinical research coordinators, research coordinators, OPS research assistants, and student interns on protocols for participant enrollment. Implements good clinical practice (GCP) and follows the Code of Federal Regulations (CFR) and Health Insurance Portability and Accountability Act (HIPAA), and follows all University of Florida policies and procedures. Liaison for hospital billing for research subjects and department invoice/PO submissions. Performs biomedical procedures such as bio specimen collection, centrifuging, pipetting, freezing and sample storage; and trains staff on specific study processing. Ensures proper IATA shipping procedures are followed. Works with Emergency Medicine principal investigators (PIs) and divisional/department leadership to coordinate research studies and programs that focus on PAMI (Pain Assessment and Management Initiative) and alternatives to opioids and patient safety. Implements quantitative and qualitative data collection including REDCap data variables, data verification, and coding. Develops educational outreach materials, presentations, and infographics. Assists with abstract and manuscript submissions. Assists PIs with preparation of project reports as needed. Assists the Associate Chair of EM Research, Assistant Director of Clinical Research, Associate Director of Research, and PI's in identifying new funding opportunities and proposal development related to pediatrics, EMS, pain, patient safety, sepsis and precision medicine topics. Participates in EM research and quality improvement related state partnerships. Other assigned duties as determined by EM Research leadership team. Expected Salary: $65,000 to $76,000 Minimum Requirements: Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. Preferred Qualifications: Experience in phlebotomy, specimen processing, and clinical research is preferred. Experience and knowledge in general laboratory procedures and meticulous in recording, tracking & reporting of data collected is preferred. Experience in research, project management, data, integrative, over-the-counter, and nonpharmacologic pain management options, patient education, and integrative medicine is preferred. Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing. Coordinates multiple tasks and works independently and productively in a fast paced, deadline-oriented environment. This position requires proficiency in data management and superior organization skills. Integrity, careful attention to detail; ability to maintain confidentiality, demonstrate professionalism and respect for subjects' rights and individual needs; willing to learn and maintain skills in accordance with HIPAA regulations and Good Clinical Practice guidelines. Special Instructions to Applicants: In order to be considered, you must upload your cover letter, resume, and 3 references Normal work hours will include a mix of 8 hour shifts Monday through Sunday during the time period of 8:00am to 9:00pm based on study schedules with a mix of day and evening shifts and 2-3 weekend shifts per month. There will be occasional on call duties, and travel for professional presentations and activities. This is a time-limited position. Time-limited positions are based on circumstances, such as funding sources, which control the length of the advertised position. Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES), which can be found at ********************** The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call (352) 392-2HRS or the Florida Relay System at ************** (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law. Driver's license required. Application must be submitted by 11:55 p.m. (ET) of the posting end date. This requisition has been reposted. Previous applicants are still under consideration and need not reapply. Health Assessment Required: Yes
    $65k-76k yearly 60d+ ago
  • Clinical Research Coordinator Fort Myers South FL

    U.S. Renal Care, Inc. 4.7company rating

    Fort Myers, FL jobs

    The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable. Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed. Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research. Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job. Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization. Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures. Regular and reliable attendance is required for the job.
    $44k-63k yearly est. 1d ago
  • *Clinical Research Coordinator needed in Hollywood, FL (Spanish-Speaker)

    Healthplus Staffing 4.6company rating

    Hollywood, FL jobs

    Medical Research Coordinator (Full Time) - Hollywood, FL (Spanish-speaker) We are looking for an experienced, bilingual (Spanish-speaking) Medical Research Coordinator to join our research team in Hollywood, FL. The Medical Research Coordinator will be responsible for the coordination of clinical research studies while ensuring compliance with all applicable regulations and guidelines. The ideal candidate will possess a strong understanding of clinical research, clinical trials, and the medical field. The Medical Research Coordinator should have excellent communication, organizational, and problem-solving skills with an ability to prioritize tasks effectively. Responsibilities Develop and maintain clinical study documents and coordinate all aspects of clinical trials including case report forms, informed consents, and other regulatory documents. Monitor clinical trials and ensure that they are conducted in accordance with protocols, standard operating procedures, and applicable regulations. Train, support and delegate tasks to clinical research staff. Conduct data review and analysis. Develop and manage budgets, timelines, and communications. Ensure compliance with all applicable federal, state, and local regulations. Maintain accurate records of research activities and submit reports to the appropriate authorities. Develop and implement strategies for data collection. Work with study investigators to ensure that the study is conducted in compliance with the protocol. Develop study-related materials and provide support to investigators. Provide guidance to investigators on the interpretation and implementation of the protocol. Coordinate and participate in monitoring visits. Perform other duties as assigned. Requirements Healthcare related background, such as FMD (Foreign Medical Doctor) NP, LPN, or RN. At least two years of experience as a Clinical Research Coordinator. Proficient in Spanish. Excellent communication, organizational, and problem-solving skills. Ability to prioritize tasks effectively. Ability to work independently and as part of a team. Ability to work in a fast-paced environment. Knowledge of applicable federal and state regulations. Knowledge of clinical research processes and procedures. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, etc.). If you are an experienced Medical Research Coordinator who is looking for a new opportunity in Hollywood, FL, we encourage you to apply today! The HealthPlus Team
    $49k-71k yearly est. 60d+ ago
  • Clinical Research Coordinator (48164)

    Platinum Dermatology Partners 3.8company rating

    Aventura, FL jobs

    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: This is an in-person, FT position at the Aventura clinic. 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.
    $43k-64k yearly est. 18d ago
  • Pre-Trial Specialist II

    Choice of New Rochelle In 3.4company rating

    White Plains, NY jobs

    Job Description Title: Pre-Trial Specialist II Reports To: Program Director - Pre-Trial Services FLSA: Non-Exempt Status: Full-time Supervisory Responsibility: Not Applicable Purpose of the Role: The Pretrial Specialist II is a critical member of the Pretrial Services team, responsible for providing case management and administrative support to the court's judges, attorneys, and other stakeholders. The Pretrial Specialist II will oversee the daily operations of the Pretrial unit in the absence of the Program Director, ensuring efficient and effective management of cases, while maintaining the highest level of professionalism and discretion. The Senior Pretrial Specialist will serve as a direct support to the Program Director - Pretrial Services. Essential Functions of the Role: Provide guidance and training to junior staff members on pretrial procedures, court rules, and policies. Collaborate with judges, attorneys, law enforcement agencies, and other court staff to ensure effective communication and coordination on pretrial matters. Develop and maintain positive working relationships with court personnel, judges, and other stakeholders. Identify and implement process improvements to enhance efficiency, productivity, and customer service. Participate in special projects and committees as assigned by the Pretrial Program Director. Prepare and maintain accurate and detailed records, reports, and statistics related to pretrial matters. Work collaboratively with the court and other pretrial staff team to facilitate and ensure caseload participants' successful completion of mandated supervision appointments and court appearances during the pendency of their legal case. Review legal and court screening documentation and work with participants to analyze their offending behavior patterns, identifying behavioral changes, need for implementation of supports that may reduce likelihood of any pretrial arrests. Provide on-call support as needed. Ensure the timely flow of community outreach and case management activities to meet program goals and objectives. Provide all services in a manner that is gender-responsive, trauma-informed, and that adheres to the core principles of risk-need-responsivity. Special projects and other duties as assigned. Decision-Making Authority: Decisions regarding Pretrial Services are to be made with guidance and collaboration of the Director to whom the Pretrial staff is assigned. It is expected that the Pretrial Specialist will show an increasing ability to make decisions independently on routine matters as knowledge and experience progresses. Working Relationships: Internal: Pretrial Supervisor, Director of Criminal Justice External: Dept. of Social Services, Mental Health Providers, Primary Care Physicians, Parole Officers, Legal Services, District Attorney's Office, Court Officials, Police Departments, etc. Work Schedule: Monday - Friday, 9am - 5pm with some flexibility around client needs. Physical Environment: Traditional office environment. Must be comfortable attending appointments at various courts, agencies, facilities and client's homes. Physical Demands: Must be able to drive a motor vehicle and carry up to 20 lbs. Mental and Visual Demands: Flow of work and nature of duties involve normal coordination of mind and eyes much of the time. Must be able to interact with persons having mental health issues, periods of instability (i.e. lack of shelter, food, clothing or support), recently released from an institution (i.e. hospital, prison), limited comprehension and/or ability to manage through complex scenarios Qualifications for this Role: Bachelor's degree or equivalent experience. Minimum of four years of experience working in human services with individuals with substance use disorders, co-occurring mental health and substance use disorders and involvement in the criminal justice system. Extensive knowledge of community treatment, support services and resources Knowledge of the criminal justice system, court processes and alternative to detention/incarceration services Valid driver's license required and a driving record that will permit the use of an Agency vehicle to transport clients to appointments or other activities as needed. Bilingual English/Spanish a plus. Job Type: Full-time Benefits: 401(k) matching Health insurance Dental insurance Vision insurance Health reimbursement account Paid time off Referral program Schedule: Monday to Friday Work Location: In-person Salary range: $65,000 - $70,000
    $65k-70k yearly 2d ago

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