Research Coordinator jobs at Nationwide Children's Hospital - 503 jobs

The Flanigan laboratory seeks a clinical research assistant to participate in cleaning and analysis of data contained within a large database of genetic and clinical information from subjects with muscular dystrophy. The majority of time (~80%) will be spent curating this database, based upon specific directions from the principal investigator and subinvestigators; harmonizing data collection; validating data; working closely with investigators to prepare data for statistical analysis; and participating in the preparation of for publication/presentation. A minority of time (~20%) will be spent in contact with subjects for consenting or updating clinical records, under the oversight of the Center for Gene Therapy clinical research services team. Summary: Supports the working groups of the Biospecimen Core Resource (BCR) of The Cancer Genome Atlas (TCGA) project. Supports the leadership and staff of the BCR by conducting various clerical, organizational, and logistical tasks. Job Description: Essential Functions: Collects and organizes research data for analysis. Maintains accurate and complete records of research findings. Assists in the preparation of scientific publications, abstracts, posters, presentations, and grant proposals. Prepares and submits regulatory documents and study protocols for approval. Maintains office supplies and equipment. Places requests for additional equipment as needed. Coordinates all travel related to Clinical Outreach training sessions, TCGA Steering committee meetings, TCGA workshops, etc. Prepares reimbursement requests. Education Requirement: Bachelor's degree, or equivalent work-related experience, required. Skills: Understanding of medical terminology, required. Working knowledge of PCs and word processing and data management software, required. Excellent verbal and written communication, organizational, and interpersonal skills, required. Must be goal-oriented, self-directive, and creative with the ability to actively participate as a team player. Physical Requirements: OCCASIONALLY: Bend/twist, Climb stairs/ladder, Flexing/extending of neck, Hand use: grasping, gripping, turning, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Reaching above shoulder, Repetitive hand/arm use, Squat/kneel FREQUENTLY: Computer skills, Decision Making, Interpreting Data, Problem solving, Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Color vision, Depth perception, Hearing acuity, Peripheral vision, Seeing - Far/near "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

6 Medical Full Time 36 hours/week Nights 7p-730a Onsite Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill. Responsibilities: 1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties. 2. Demonstrates personal and professional accountability for self and staff. 3. Maintains unit safety for staff and patients. 4. Participates in performance improvement. 5. Participates in and supports staff recruitment and retention efforts. 6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources. 7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel. 8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise. 9. Promotes a positive work environment and staff engagement. 10. Serves as a clinical resource to the interdisciplinary team. 11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served. 12. Other duties as required. Other information: Technical Expertise 1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required. 2. Valid Ohio license. 3. Current Health Care Provider BLS training from the American Heart Association is required. 4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements. 5. Relevant professional nursing certification, preferred. Education and Experience 1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position. 2. Certification: May differ based on department/unit 3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required. 4. Years of experience supervising: Previous charge nurse or other leadership experience is required. 5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required. Full Time FTE: 0.900000 Status: Onsite

Behavioral Health Unit Full Time 36 hours/week Nights 7p-730a every other weekend and holiday Onsite Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill. Responsibilities: 1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties. 2. Demonstrates personal and professional accountability for self and staff. 3. Maintains unit safety for staff and patients. 4. Participates in performance improvement. 5. Participates in and supports staff recruitment and retention efforts. 6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources. 7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel. 8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise. 9. Promotes a positive work environment and staff engagement. 10. Serves as a clinical resource to the interdisciplinary team. 11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served. 12. Other duties as required. Other information: Technical Expertise 1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required. 2. Valid Ohio license. 3. Current Health Care Provider BLS training from the American Heart Association is required. 4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements. 5. Relevant professional nursing certification, preferred. Education and Experience 1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position. 2. Certification: May differ based on department/unit 3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required. 4. Years of experience supervising: Previous charge nurse or other leadership experience is required. 5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required. Full Time FTE: 0.900000 Status: Onsite

Grow your career at Cedars-Sinai! The Angeles Clinic and Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. We are committed to bringing innovative therapeutic options to all of our patients with cancer. As part of this commitment, our cancer clinical trials program has been expanded to include Experimental Therapeutics (Phase I) and Drug Development programs. With this commitment strengthened, we can continue to make advances in cancer care. Join our team and contribute to groundbreaking research. We're excited to share an opportunity for a Research Nurse Coordinator III (Full-Time) position! This is an on-site role with a 4/10 schedule, offering a great work-life balance. If you hold an active RN license in California and have prior experience as a nurse working on clinical trials, we'd love for you to apply. We highly value clinical research nurse experience, as you'll play a key role in supporting and coordinating clinical trials. A SOCRA or ACRP certification is required for the level III role-but if you don't have one just yet, don't worry! You may still be considered for a level II position. We are currently offering a $10,000 sign-on bonus for this position. A Little More About What You Will be Doing The Research Nurse Coordinator III is responsible for all activities associated with clinical study coordination, subject enrollment, data management/integrity, regulatory compliance, project/study evaluation and interfacing with participants and family members. Coordinates the clinical logistics of the study and works in tandem with the Research and/or Clinical Nurse who work to provide hands-on clinical care to the research participants. Utilizes clinical nursing background and extensive/complex research protocol knowledge to serve as liaison between nursing staff, Principal Investigator, other research staff, and study participants. Serves as a resource and mentor to the research staff by providing guidance, instruction, training, work-review and leading staff. Primary Duties and Responsibilities Responsible for clinical study activities, coordination, adherence to protocols and serves as a liaison between study participants, Principal Investigator (PI), and other research staff. Provides educational services to research participants and family regarding study participation, participants current clinical condition, and or disease process. Assesses and documents adverse events as reported by research participants, works closely with PI to document according to department process (grade, attribution, treatment, etc.), and reports to regulatory and sponsor as required. Records research data where assessed or reported by patient (i.e. symptoms of treatment). Creates and presents education materials to the interdisciplinary team to on study requirements. Collaborates with the interdisciplinary team to create and communicate a plan of care. Triages patient by phone and provides clinical information to the patient. Completes and documents study participant enrollment, assessment/reassessment, education, and follow-up activities and ensures protocol is followed. Coordinates study participant tests and procedures as required. Prepares data spreadsheets for Investigator and/or department. Performs general oversight of research portfolio as it pertains to the clinical coordination of the studies. Serves as a resource and mentor to other research staff by providing training, work review and leading staff. Provides guidance, instruction and expertise to team members on study requirements and clinical coordination of the studies. May assist with grant proposals, publication preparation, and/or presentations. May process, ship, track or otherwise handle research specimens. Requirements: Bachelor's Degree Nursing or Health Science required. 5 years of Clinical Nursing & Research Experience required. Valid CA RN license required. BLS certification from the American Heart Association or American Red Cross required Certification in Clinical Research SOCRA or ACRP required for a level III Research Nurse.

OHR uses primordial chemistry and synthetic biology to fashion strategic chemicals. Our technology enables the creation of carbon chains of deterministic length without cells, co-factors, or typical oil contaminants. With a core value of sustainability, OHR is focused on building resilient supply chains through innovative solutions. Role Description OHR Synbiosis seeks Sr. Research Associates in Chemistry R&D to drive technical developments across R&D groups and between the broader OHR organization. The candidates will assist in, execute, and design experiments in synthetic chemistry routes of OHR's Creationary Chemistry TM platform, including organic chemistry synthetic pathway exploration and discovery, reaction process optimization, catalyst development, analytical methodologies, product application, and external technical partnership management. Responsibilities Exemplify excellence in lab safety and chemical hygiene practices. Perform research and development on OHR's Creationary Chemistry TM platform. Be a workhorse in the drive to deliver critical chemicals to public and private customers in need. Assist in discovery of organic and synthetic chemistry reactions to create novel synthetic routes leveraging OHR's proprietary enzymatic intermediates. Explore chemical reaction development across product pathways, including solvent selection, catalyst elucidation/optimization, reaction conditions, etc. Contribute to design, optimization, and scaling of catalytic processes, including acid/base catalysis, heterogenous supported-metal and inorganic catalysis, hydrogenation, and hydrodeoxygenation. Generate data to aid analytical methodology development, in-house and with partners, to build quantitative standing of chemical reactions. Build testing and characterization protocols for OHR's aviation and aerospace fuel product portfolio and additional proprietary emerging product portfolios. Design, test, build, and validate novel heterogeneous inorganic catalysts. Contribute to research and IP strategies to solidify the Creationary Chemistry TM platform. Draft, optimize, publish, and train colleagues on technical procedures and specialized reactions. Provide detailed data and protocols for technology transfer to OHR's Manufacturing team and external partners. With Project Managers and Executives, implement project management systems to track Chemistry R&D developments and KPIs. Required Qualifications Bachelor's of Science in Chemistry, or equivalent area, from an accredited university. Exemplary past demonstration of lab and workplace safety. Direct experience contributing to technical chemistry research and development teams through: discovery of synthetic chemistry pathways, contributing to process chemistry and reaction optimization, exploring and selecting or synthesizing and evaluating heterogeneous metal catalysts for hydrogenation and reduction chemistry, discovering or optimizing acid and base catalyzed reactions, or developing of analytical methods of compound identification and quantification, including utilization of GC-FID, HPLC, LC/MS, GC/MS, NMR, and ICP. Direct hands-on experience converting established batch reactions to flow/continuous reactions.

Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. The Research Coordinator III is embedded within the clinical research department and supports clinical trials across multiple ophthalmology subspecialties including glaucoma, cornea, ocular oncology, neuro-ophthalmology and plastics. This role collaborates closely with physicians, sponsors and monitors to support the successful conduct of research studies. Responsibilities include screening, enrolling and consenting patients for clinical trials, preparing and maintaining IRB submissions and sponsor-required regulatory binders, ensuring readiness for monitoring visits and audits and collecting and entering study data in accordance with protocol requirements while maintaining HIPAA and research compliance. The coordinator also schedules patient visits, manages investigational drug and device trials and supports special projects including multi-center studies and investigation into new drug and device protocols. A caregiver in this position works between 7:30am to 4:00pm. A caregiver who excels in this role will: * Demonstrate exceptional coordination and compliance of the implementation and conduct of human subject research projects. * Assist with research study design and protocol development as applicable. * Independently direct large, complex, multi-center clinical research protocols/programs and coordinate the implementation and conduct of research projects, ensuring adherence to research protocol. * Report Serious Adverse Events and/or safety as they occur and complete Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines. * Communicate with sponsors, monitors and research personnel to ensure all aspects of study compliance. * Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions. * Collaborate with primary investigators, sponsors and research caregivers to plan, conduct and evaluate project protocols, including research subject recruitment. * Monitor and report project status. * Complete regulatory documents, data capture and monitoring plans. * Complete and oversee protocol related activities. * As delegated, attain and maintain clinical competencies for unlicensed caregivers, such as phlebotomy, vital signs, ECG, POC testing and other testing as required. * Oversee and monitor research data to maintain quality. * Develop and maintain knowledge of research protocols to coordinate the comprehensive and compliant execution of assigned protocols. * Assist with the preparation for audits and response to audits. * Develop or assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures. * Maintain study personnel certification records (License, CV, CITI). * Conduct and document the informed consent process. * Assist the PI with research study design and development of research protocol. * Submit the study to appropriate agencies in support of the research programs and assist with annual and other reporting requirements. * Contribute to or assist with research project budget development. Minimum qualifications for the ideal future caregiver include: * High School Diploma or GED and five years of experience as a Research Coordinator II or performing the role of a Research Coordinator II OR Bachelor's Degree in a healthcare or science-related field and three years of experience * Demonstrated proficiency with a variety of computer-based skills (word processing, spreadsheets, databases and presentation software) * Understanding of the basic concepts of study design Preferred qualifications for the ideal future caregiver include: * Associate's or Bachelor's Degree in a healthcare or science-related field Physical Requirements: * Ability to perform work in a stationary position for extended periods * Ability to operate a computer and other office equipment * Ability to communicate and exchange accurate information * In some locations, ability to move up to 25 pounds Personal Protective Equipment: * Follows standard precautions using personal protective equipment as required. Pay Range Minimum Annual Salary: $57,510.00 Maximum Annual Salary: $87,697.50 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. As Research Coordinator I, your role is crucial in enrolling patients into clinical trials, conducting study visits and collecting questionnaires with important study-related information. While numerous responsibilities can be difficult to juggle at times, your team will encourage you to enhance your skills and improve your ability to identify new avenues of treatment. Come join a culture devoted to pushing the needle forward in healthcare. We are looking for a candidate who enjoys patient-facing interaction. Recruitment is most successful when we have a Research Coordinator who is engaged in and committed to talking to our patients. The position will be part of a diverse, multi-disciplinary team with the opportunity to collaborate with investigators and other team members. A caregiver in this position works 8:00am - 4:00pm. A caregiver who excels in this role will: * Coordinate the compliant implementation and conduct of human subject research projects. * Maintain regulatory documents and binders, conduct data management, complete IRB submissions and communicate with the research team. * Report and complete serious adverse events and/or safety logs. * Communicate with sponsors, monitors and research personnel to ensure all aspects of study compliance. * Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions. * Schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits. * Plan, conduct and evaluate project protocols and research subject recruitment. * Monitor and report project status and research data. * Complete regulatory documents, data capture, monitoring plans and protocol-related activities. * Assist with preparing and responding to audits and maintaining research tools. Minimum qualifications for the ideal future caregiver include: * High School Diploma or GED * Three years of experience as a Research Coordinator I OR Associate's or Bachelor's Degree in Healthcare or a science-related field with one year of experience * Demonstrated proficiency with a variety of computer-based skills (word processing, spreadsheets, data entry, Excel, databases and presentation software) * Previous clinical research experience Preferred qualifications for the ideal future caregiver include: * Associate's or Bachelor's Degree in Healthcare or a science-related field * Epic experience Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we're dedicated to providing what matters most to you: ******************************************** Physical Requirements: * Ability to perform work in a stationary position for extended periods * Ability to operate a computer and other office equipment * Ability to communicate and exchange accurate information * In some locations, ability to move up to 25 pounds Personal Protective Equipment: * Follows standard precautions using personal protective equipment as required. * May require working irregular hours. Personal Protective Equipment: * Follows standard precautions using personal protective equipment as required. Pay Range Minimum Annual Salary: $47,530.00 Maximum Annual Salary: $72,475.00 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

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

Job Description Responsibilities Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are Radiology Forward . With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people with the commitment to a better healthcare experience. When you join us as a Clinical Research Coordinator, you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders- patients, providers, payors, and regulators to achieve the best clinical outcomes. You Will: Works with broad spectrum of health care providers for many disease types, physicians, nurses, other research coordinators, imaging techs and support staff Read and interpret research study protocols in order to define the procedures that will be provided to the clinical research site Translate the designated study procedures into a plan for operational implementation Must be able to articulate study process and produce study flow and source documents that are instructive to the technical and clerical staff Maintain impeccable records of all interactions with clients and companies Assures confidentiality of patient's records and study related materials that are provided under non-disclosure agreements by the research site, pharmaceutical company, or imaging vendor Assist the scheduling team with any problems or difficulties to achieve patient study time lines Maintains accurate study files Provides each imaging site with binders and assists them with relevant information in order to procure correct imaging for each study Visits multiple imaging centers in California to ensure training and study compliance. Attends on site pre study and site initiation visits as needed Adjusts schedule to ensure site visits and training sessions can be accomplished Must be able to problem solve and resolve data queries in a timely manner Work environment is organized and functions efficiently You Are: Genuinely passionate about customer service and exercise sound judgement and an ability to remain professional in all situations Able to demonstrate high level of attention to detail, excellent organizational skills and have the ability to multitask Able to thrive in a fast-paced environment, have a knack for prioritizing work with a structured approach, and enjoy providing world class customer service To Ensure Success In This Role, You Must Have: High school graduate (some college preferred) MA certificate, or at least 2 years in a clinical setting or imaging center At least 2 years in a research environment with study operations responsibilities Bachelor's degree or higher may substitute for experience We Offer: Comprehensive Medical, Dental and Vision coverages. Health Savings Accounts with employer funding. Wellness dollars 401(k) Employer Match Free services at any of our imaging centers for you and your immediate family.

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role:Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within Neurocrine, at Contract Research Organizations (CROs), and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation. _ Your Contributions (include, but are not limited to): Working with the Clinical Trial Managers (CTMs), helps ensure clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies Serves as a team member for of assigned clinical studies Prepares data / information for technical and study design discussions Provides administrative support, ensuring invoices are paid, tracking metrics, issues for CROs and other contract service providers (CSPs) for assigned studies Participates in study team meetings and tracks study issues. Under direction of the CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts Participates in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs Develops relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs and requirements are met Collaborates with CTM and fellow team members to expedite study start up processes for trials and to resolve quality issues with documents Pre-populates essential document templates and creates essential document packets Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study Performs IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials Participates in team meetings by providing clinical document and IRB/IEC status updates to the ClinOps team Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs Manages document translation process with vendors Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs Supports study monitors by providing updates regarding outstanding documents and addressing eTMF or IRB/IEC related questions Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the eTMF system Works with the NBI and/or the CRO study team to resolve eTMF QC findings and ensure the eTMF QC is documented Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan, if available Other duties as assigned Requirements: BS/BA in Scientific field or equivalent AND 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred OR Master's degree in Scientific field or equivalent AND Some experience as noted above Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines Works to improve tools and processes within functional area Ability to work as part of a team Strong computer skills Good communications, problem-solving, analytical thinking skills Sees impact on department Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency Developing project management skills Ability at analyzing data and information to derive options/recommendations for management considerations Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out. Some trial management protocol and process knowledge General understanding of Clinical Research industry and the relevant environments in which it operates Ability to plan activities and works well under changing circumstances; manages time effectively #LI-SA Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within Neurocrine, at Contract Research Organizations (CROs), and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation. _ Your Contributions (include, but are not limited to): * Working with the Clinical Trial Managers (CTMs), helps ensure clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies * Serves as a team member for of assigned clinical studies * Prepares data / information for technical and study design discussions * Provides administrative support, ensuring invoices are paid, tracking metrics, issues for CROs and other contract service providers (CSPs) for assigned studies * Participates in study team meetings and tracks study issues. Under direction of the CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts * Participates in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary * Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs * Develops relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs and requirements are met * Collaborates with CTM and fellow team members to expedite study start up processes for trials and to resolve quality issues with documents * Pre-populates essential document templates and creates essential document packets * Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study * Performs IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials * Participates in team meetings by providing clinical document and IRB/IEC status updates to the ClinOps team * Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs * Manages document translation process with vendors * Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs * Supports study monitors by providing updates regarding outstanding documents and addressing eTMF or IRB/IEC related questions * Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the eTMF system * Works with the NBI and/or the CRO study team to resolve eTMF QC findings and ensure the eTMF QC is documented * Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan, if available * Other duties as assigned Requirements: * BS/BA in Scientific field or equivalent AND 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred OR * Master's degree in Scientific field or equivalent AND Some experience as noted above * Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines * Works to improve tools and processes within functional area * Ability to work as part of a team * Strong computer skills * Good communications, problem-solving, analytical thinking skills * Sees impact on department * Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency * Developing project management skills * Ability at analyzing data and information to derive options/recommendations for management considerations * Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive * Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out. * Some trial management protocol and process knowledge * General understanding of Clinical Research industry and the relevant environments in which it operates * Ability to plan activities and works well under changing circumstances; manages time effectively #LI-SA Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Accurately and professionally works with RN study coordinators to assist in the execution all clinical projects assigned to him/her: assists in project initiation, maintains patient continuance, assures protocol compliance, reports to nurses on patient/progress status. Needs phlebotomy training and experience. Contributes to the smooth patient flow during patient office visits. KNOWLEDGE AND SKILLS: Please describe any specialized knowledge or skills, which are REQUIRED to perform the position duties. Do not personalize the job description, credentials, or knowledge and skills based on the current associate. List any special education required for this position. EDUCATION: High School education, or its equivalent, Associate degree or its equivalent preferred. YEARS OF EXPERIENCE: 1-3 years prior medical office experience required. REQUIRED SKILLS AND KNOWLEDGE: Photocopier, fax equipment, computer, all medical equipment appropriate to research and strong organizational skills. EKG and phlebotomy training with proficient skills to perform tasks. LICENSES & CERTIFICATIONS : Certification as Medical Assistant/Medical Technician within 6 months from hire date. CPR by Red Cross or American Heart Association 1. Collects all clinical data in an accurate and timely manner for assigned research protocols. • Performs data collection activities as required by protocol. • Assists in initiation and maintenance of accurate project execution. • Adjusts information aids, standing orders, study outlines when amendments to the protocols occur with assistance of RN. • Provides sponsors with expedited data to meet deadlines for publications. • Assists with data collection on sub-studies associated with project. • Assists physicians and nurses in the evaluations of patients. • Prepares patients for office visits. • Performs phlebotomy, vital signs, EKG, and other tasks as needed and required. • Has knowledge of FDA requirements for Good Clinical Practice. 2. Participates directly in patient care duties associated with projects and performs laboratory support tasks as needed. • Maintains required skills. • Maintains accurate awareness of other clinical projects. • Accurately and professionally draws blood. • Processes blood samples according to research protocols. • Packages sample vials and prepares for shipping to appropriate laboratory as designated by sponsor. 3. Encourages patient enrollment and participation in research protocol. • Works closely with patient, family and Research RN staff to assure good patient rapport and good clinical care, re-enforcing desire for patient continuance in study. • Alerts RN staff if compliance or continuance issues arise to assist in resolution. 4. Participation in patient care activities to provide compliance and efficient care delivery • Serves as a back-up contact for patients and other caregivers in assuring all research and non-research clinical needs are achieved. • Assures patients are scheduled for and receive appropriate follow-up evaluations. • Assures patients are well educated as to the importance of compliance with study objectives; seeks help as needed from RN. • Assists all research nurses in facilitating good protocol compliance and clinical patient care. • Makes suggestions on how to facilitate special or acute needs of patients as observed or noted. • Attends all required training sessions and completes all required certifications. 5. Performs other related duties as required or requested. • Assures the Center's needs are cooperatively met, needs are recognized, and action taken as required to obtain desired outcomes. • Offers support and cooperation as needed for best outcome.

Accurately and professionally works with RN study coordinators to assist in the execution all clinical projects assigned to him/her: assists in project initiation, maintains patient continuance, assures protocol compliance, reports to nurses on patient/progress status. Needs phlebotomy training and experience. Contributes to the smooth patient flow during patient office visits. KNOWLEDGE AND SKILLS: Please describe any specialized knowledge or skills, which are REQUIRED to perform the position duties. Do not personalize the job description, credentials, or knowledge and skills based on the current associate. List any special education required for this position. EDUCATION: High School education, or its equivalent, Associate degree or its equivalent preferred. YEARS OF EXPERIENCE: 1-3 years prior medical office experience required. REQUIRED SKILLS AND KNOWLEDGE: Photocopier, fax equipment, computer, all medical equipment appropriate to research and strong organizational skills. EKG and phlebotomy training with proficient skills to perform tasks. LICENSES & CERTIFICATIONS : Certification as Medical Assistant/Medical Technician within 6 months from hire date. CPR by Red Cross or American Heart Association 1. Collects all clinical data in an accurate and timely manner for assigned research protocols. * Performs data collection activities as required by protocol. * Assists in initiation and maintenance of accurate project execution. * Adjusts information aids, standing orders, study outlines when amendments to the protocols occur with assistance of RN. * Provides sponsors with expedited data to meet deadlines for publications. * Assists with data collection on sub-studies associated with project. * Assists physicians and nurses in the evaluations of patients. * Prepares patients for office visits. * Performs phlebotomy, vital signs, EKG, and other tasks as needed and required. * Has knowledge of FDA requirements for Good Clinical Practice. 2. Participates directly in patient care duties associated with projects and performs laboratory support tasks as needed. * Maintains required skills. * Maintains accurate awareness of other clinical projects. * Accurately and professionally draws blood. * Processes blood samples according to research protocols. * Packages sample vials and prepares for shipping to appropriate laboratory as designated by sponsor. 3. Encourages patient enrollment and participation in research protocol. * Works closely with patient, family and Research RN staff to assure good patient rapport and good clinical care, re-enforcing desire for patient continuance in study. * Alerts RN staff if compliance or continuance issues arise to assist in resolution. 4. Participation in patient care activities to provide compliance and efficient care delivery * Serves as a back-up contact for patients and other caregivers in assuring all research and non-research clinical needs are achieved. * Assures patients are scheduled for and receive appropriate follow-up evaluations. * Assures patients are well educated as to the importance of compliance with study objectives; seeks help as needed from RN. * Assists all research nurses in facilitating good protocol compliance and clinical patient care. * Makes suggestions on how to facilitate special or acute needs of patients as observed or noted. * Attends all required training sessions and completes all required certifications. 5. Performs other related duties as required or requested. * Assures the Center's needs are cooperatively met, needs are recognized, and action taken as required to obtain desired outcomes. * Offers support and cooperation as needed for best outcome.

Accurately and professionally works with RN study coordinators to assist in the execution all clinical projects assigned to him/her: assists in project initiation, maintains patient continuance, assures protocol compliance, reports to nurses on patient/progress status. Needs phlebotomy training and experience. Contributes to the smooth patient flow during patient office visits. KNOWLEDGE AND SKILLS: Please describe any specialized knowledge or skills, which are REQUIRED to perform the position duties. Do not personalize the job description, credentials, or knowledge and skills based on the current associate. List any special education required for this position. EDUCATION: High School education, or its equivalent, Associate degree or its equivalent preferred. YEARS OF EXPERIENCE: 1-3 years prior medical office experience required. REQUIRED SKILLS AND KNOWLEDGE: Photocopier, fax equipment, computer, all medical equipment appropriate to research and strong organizational skills. EKG and phlebotomy training with proficient skills to perform tasks. LICENSES & CERTIFICATIONS : Certification as Medical Assistant/Medical Technician within 6 months from hire date. CPR by Red Cross or American Heart Association 1. Collects all clinical data in an accurate and timely manner for assigned research protocols. • Performs data collection activities as required by protocol. • Assists in initiation and maintenance of accurate project execution. • Adjusts information aids, standing orders, study outlines when amendments to the protocols occur with assistance of RN. • Provides sponsors with expedited data to meet deadlines for publications. • Assists with data collection on sub-studies associated with project. • Assists physicians and nurses in the evaluations of patients. • Prepares patients for office visits. • Performs phlebotomy, vital signs, EKG, and other tasks as needed and required. • Has knowledge of FDA requirements for Good Clinical Practice. 2. Participates directly in patient care duties associated with projects and performs laboratory support tasks as needed. • Maintains required skills. • Maintains accurate awareness of other clinical projects. • Accurately and professionally draws blood. • Processes blood samples according to research protocols. • Packages sample vials and prepares for shipping to appropriate laboratory as designated by sponsor. 3. Encourages patient enrollment and participation in research protocol. • Works closely with patient, family and Research RN staff to assure good patient rapport and good clinical care, re-enforcing desire for patient continuance in study. • Alerts RN staff if compliance or continuance issues arise to assist in resolution. 4. Participation in patient care activities to provide compliance and efficient care delivery • Serves as a back-up contact for patients and other caregivers in assuring all research and non-research clinical needs are achieved. • Assures patients are scheduled for and receive appropriate follow-up evaluations. • Assures patients are well educated as to the importance of compliance with study objectives; seeks help as needed from RN. • Assists all research nurses in facilitating good protocol compliance and clinical patient care. • Makes suggestions on how to facilitate special or acute needs of patients as observed or noted. • Attends all required training sessions and completes all required certifications. 5. Performs other related duties as required or requested. • Assures the Center's needs are cooperatively met, needs are recognized, and action taken as required to obtain desired outcomes. • Offers support and cooperation as needed for best outcome.

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.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively · Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL · Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. · Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues · Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) · Review compound-specific ICF and develop study-specific ICF templates · Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection · Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents · Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites · May coordinate the preparation, conduct, and presentations at Investigator Meetings · Review monitoring visit reports for completeness, accuracy, and adherence to the protocol · Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation · May conduct UAT for EDC / IRT and data listing review of EDC data for analysis · Compile and review appendices for preparation of clinical study reports · Review and/or create study documents (e.g. newsletters, and various study / site trackers) · Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion · Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately · May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: · None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: · BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, · MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, · Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: · Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: · Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation · Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures · Experience with development of prospective site-selection criteria · Familiar with medical terminology, and basic concepts of clinical research · Ability to deal with time demands, incomplete information or unexpected events · Experience in interactions with outside vendors, e.g., CROs and contract labs · Demonstrated ability to write and present clearly using on scientific and clinical issues terminology · Applies technical standards, principles, theories, concepts and techniques · Advanced computer skills · Good organizational and planning skills · Strong interpersonal skills and communication skills (both written and oral) · Ability to work effectively in a team/matrix environment · Ability to understand technical, scientific and medical information · Demonstrated success in problem-solving · Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: · Works on assigned problems of moderate scope with analysis of situation or data required. · Exercises judgment within defined procedures and practices to determine appropriate action. · Builds productive internal and external working relationships. · Uses professional concepts and company policies and procedures to solve a variety of routine problems. · Demonstrated professional collaboration skills · Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: · Resilient in the context of a rapidly changing environment · Organized with a systematic approach to prioritization · Works independently to meet objectives and completes tasks within established timelines. · Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: · We drive for results, so patients can survive and thrive. · We are resilient in the face of adversity, and tireless in advancing our science. · We celebrate our long history of prolific drug discovery and rigorous drug development. · We unite to launch innovative medicines for difficult-to-treat cancers. · We exist to give people hope - one drug, one patient at a time. · We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: · Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), · Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) · Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: · Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively * Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL * Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues * Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Review compound-specific ICF and develop study-specific ICF templates * Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents * Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites * May coordinate the preparation, conduct, and presentations at Investigator Meetings * Review monitoring visit reports for completeness, accuracy, and adherence to the protocol * Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation * May conduct UAT for EDC / IRT and data listing review of EDC data for analysis * Compile and review appendices for preparation of clinical study reports * Review and/or create study documents (e.g. newsletters, and various study / site trackers) * Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion * Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately * May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: * Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Experience with development of prospective site-selection criteria * Familiar with medical terminology, and basic concepts of clinical research * Ability to deal with time demands, incomplete information or unexpected events * Experience in interactions with outside vendors, e.g., CROs and contract labs * Demonstrated ability to write and present clearly using on scientific and clinical issues terminology * Applies technical standards, principles, theories, concepts and techniques * Advanced computer skills * Good organizational and planning skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to work effectively in a team/matrix environment * Ability to understand technical, scientific and medical information * Demonstrated success in problem-solving * Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: * Works on assigned problems of moderate scope with analysis of situation or data required. * Exercises judgment within defined procedures and practices to determine appropriate action. * Builds productive internal and external working relationships. * Uses professional concepts and company policies and procedures to solve a variety of routine problems. * Demonstrated professional collaboration skills * Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: * Resilient in the context of a rapidly changing environment * Organized with a systematic approach to prioritization * Works independently to meet objectives and completes tasks within established timelines. * Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: * We drive for results, so patients can survive and thrive. * We are resilient in the face of adversity, and tireless in advancing our science. * We celebrate our long history of prolific drug discovery and rigorous drug development. * We unite to launch innovative medicines for difficult-to-treat cancers. * We exist to give people hope - one drug, one patient at a time. * We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: * Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), * Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) * Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: * Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

The Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Clinical Research Coordinator include: 1. Preparing for study initiation 2. Obtaining physician signatures 3. Recruiting subjects 4. Screening and scheduling subjects 5. Getting voluntary subject consent 6. Teaching subjects about protocol expectations for them 7. Performing study/protocol procedures in a detailed, accurate manner 8. Maintaining study files 9. Tracking subjects, avoiding lost-to-follow-up 10. Documenting an adverse event 11. Processing and shipping lab work 12. Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel 13. Completing case report forms (CRF's) for PI review and approval 14. Helping study monitors with CRA corrections 15. Maintaining study-specific supplies 16. Preparing for study closure and archiving Knowledge of Spanish and / or Phlebotomy Training will be an added advantage.

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 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 THIS IS AN ONSITE/IN CLINIC ROLE LOCATED IN LA JOLLA, CA 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.