Clinical Research Coordinator jobs at Providence Health & Services - 628 jobs

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

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.

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.

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

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 120 clinics, over 350 providers, and more than 2100 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. Position Purpose: Responsible for performing all administrative aspects of clinical trial research studies based upon the 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. Responsibilities: 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 the 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 the principal investigator and appropriate agencies. Notifies Director, sponsor, and IRB of any serious adverse events. Assist the physician with all procedures, including excisions, injections, laser treatments, wound care, post-op care, and dressing changes. Set up the exam room for the 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 the physician's schedule to maintain a 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 data on time, perform study monitoring in peer-to-peer inter- rated methodology. Enter all data within 2 days of the study visit by the Research Coordinators, and query resolution is performed within 2 days of the query. Random QC monitoring process to be established bythe 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 ROLE LOCATED IN LA JOLLA, CA Education and Experience: Bachelor's Degree required. Health Sciences background preferred. 3 years of prior experience; knowledge of phlebotomy techniques Knowledge of the IRB regulatory submission process, GCPs, and CFRs related to research. Certified Clinical Research Coordinator (CCRC) designation is 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 the position. Computer-literate with good keyboarding skills Ability to operate basic office equipment such as a phone, fax, copier, printer, etc. 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 machine,s 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.

DEPT MARKETING STATEMENT: UTMB's new Center for Health and Clinical Outcomes Research (H-COR) seeks Research Scientists to advance decision-grade evidence from real-world data to study and understand human health. H-COR leverages Epic EHR (Clarity/Caboodle and Cosmos), TriNetX, Medicare and other administrative data. H-COR has an interest in pairing outcomes research with secure, principled integration of high-dimensional modalities (e.g., transcriptomics, proteomics, pathogen genomics). Also of interest is the utilization of novel data sources including those derived from social media, mobile phones, wearables, and other digital sources. Researchers at H-COR collaborate across all five UTMB schools. JOB DESCRIPTION\: Conducts innovative scientific investigation by developing theories and devising scientific methods and procedures to apply scientific principles, theories and research in projects related to the mission of UTMB. Committed to the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care. Assures competence as a fully trained scientist in a specific discipline or area of expertise. ESSENTIAL JOB FUNCTIONS: Leading and contributing to high-impact health and clinical outcomes research Planning and performing advanced data analyses using UTMB's exceptional data infrastructure, with particular emphasis on electronic health record (EHR) data including EPIC, EPIC Cosmos, TriNetX, and Medicare administrative datasets Building transparent cohort definitions and phenotypes using ICD-10/PCS, CPT/HCPCS, LOINC, and RxNorm Implementing modern causal-inference strategies (e.g., target-trial emulation, robust confounding control, time-to-event and longitudinal models, principled handling of missingness, falsification and sensitivity analyses) Collaborating across UTMB's schools on defined research programs Contributing to abstracts, manuscripts, and grant applications as PI/Co-I or key personnel Integrating clinical timelines with multi-omics and other high-dimensional data while preserving clinical interpretability and privacy Presenting research at professional meetings and conferences Participating in H-COR's monthly works-in-progress seminars MINIMUM QUALIFICATIONS: Ph. D, M.D, D.O., or D.V.M in related field and one year of related experience. PREFERRED QUALIFICATIONS\: PhD or equivalent doctoral degree in a relevant discipline (health services research, epidemiology, biostatistics, data science, computer science, or a closely related field) A track record in health and clinical outcomes methods Demonstrated expertise analyzing clinical and population-health data with specific experience in EHR analytics Proficiency with large healthcare databases (Epic, Epic Cosmos, TriNetX, Medicare) Fluency in at least two of R, Python, SAS, and SQL Excellent scientific writing and communication Evidence of peer-reviewed publications commensurate with career stage Experience with OMOP and HL7 FHIR data models Hands-on practice with target-trial emulation and advanced propensity and longitudinal methods Clinically oriented NLP and time-aware feature extraction Familiarity with multi-omics data structures and cautious EHR-omics linkage Experience in HPC or cloud settings (e.g., TACC, Azure, AWS) and workflow engines that promote end-to-end reproducibility Mentorship of analysts or trainees A record of effective, cross-disciplinary collaboration in an academic health-sciences environment SALARY: Commensurate with experience. EQUAL EMPLOYMENT OPPORTUNITY: UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Job Description Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

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

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.

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.

Job Description 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.

The Clinical Research Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants. The Clinical Research Coordinator is involved in multiple aspects of the research process under the general supervision of the Research Department Administrator. Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES: Consistently exhibits behavior and communication skills that demonstrate commitment to superior customer service, including quality, care and concern with each and every internal and external customer. Applies knowledge of study design to evaluate protocol feasibility at the site. Assists Regulatory staff in preparing and submitting documents to institutional review board. Participate in study site initiation activity Attends and participates in investigator meetings and clinical trial conferences as directed. Participates in subject/patient recruitment and evaluation of eligibility. Reviews and verifies required source documents in subject's medical record to confirm study eligibility. Reviews inclusion/exclusion criteria with investigator to assure subject eligibility. Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits. Maintains patient screening enrollment logs. Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects. Follows randomization procedures per protocol. Ensures that study drugs are dispensed as per protocol by the study team or research pharmacy and that all study drug accountability records are maintained. Reviews returned drugs for compliance and documents findings. Direct care in study compliance throughout the research experience and may include. Peripheral Venipuncture per OC standard Ensures appropriate specimen collection, batching and shipping as required. Work collaboratively with the site staff to appropriately process the specimens Prepare and ship the study required specimen, per protocol manual. Obtain results and report to the attending physician investigator. Attend all clinic visits with the attending physician investigator and assist in following the study guidelines. Documents protocol deviations and exemptions. Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results). Abstracts data from medical records, clinic, consultation and referral notes to study forms and flow sheets. Resolves data queries. Schedules sponsor monitoring. Prepares case report forms and collects source documents for sponsor / audit review. Prepares for and participates in FDA inspections. Communicates effectively with subjects, research team, IRB's and sponsors Additional Duties and Responsibilities: Participates in educational and training activities. Attends continuing education offerings Supports and assists management team with department projects. Assist in maintenance of budgetary data for each clinical trial. Assist in planning department coverage (patient clinic visits, data management, meetings. Education and/or Experience: Degree in the life sciences or health sciences such as Registered Nurse (R.N.), Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), other. Continuing education participation is expected, and research certification through a recognized national organization is encouraged. (SOCRA, ACRP) NIH protection of Human subjects on line course will be required annually IATA training will be required every 2 years LANGUAGE SKILLS: • Strong Verbal and written communication skills • Proficient in written and verbal English • Bilingual is a plus COMMENTS: This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time.

Job DescriptionDescription: The Clinical Research Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants. The Clinical Research Coordinator is involved in multiple aspects of the research process under the general supervision of the Research Department Administrator. Requirements: ESSENTIAL DUTIES AND RESPONSIBILITIES: Consistently exhibits behavior and communication skills that demonstrate commitment to superior customer service, including quality, care and concern with each and every internal and external customer. Applies knowledge of study design to evaluate protocol feasibility at the site. Assists Regulatory staff in preparing and submitting documents to institutional review board. Participate in study site initiation activity Attends and participates in investigator meetings and clinical trial conferences as directed. Participates in subject/patient recruitment and evaluation of eligibility. Reviews and verifies required source documents in subject's medical record to confirm study eligibility. Reviews inclusion/exclusion criteria with investigator to assure subject eligibility. Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits. Maintains patient screening enrollment logs. Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects. Follows randomization procedures per protocol. Ensures that study drugs are dispensed as per protocol by the study team or research pharmacy and that all study drug accountability records are maintained. Reviews returned drugs for compliance and documents findings. Direct care in study compliance throughout the research experience and may include. Peripheral Venipuncture per OC standard Ensures appropriate specimen collection, batching and shipping as required. Work collaboratively with the site staff to appropriately process the specimens Prepare and ship the study required specimen, per protocol manual. Obtain results and report to the attending physician investigator. Attend all clinic visits with the attending physician investigator and assist in following the study guidelines. Documents protocol deviations and exemptions. Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results). Abstracts data from medical records, clinic, consultation and referral notes to study forms and flow sheets. Resolves data queries. Schedules sponsor monitoring. Prepares case report forms and collects source documents for sponsor / audit review. Prepares for and participates in FDA inspections. Communicates effectively with subjects, research team, IRB's and sponsors Additional Duties and Responsibilities: Participates in educational and training activities. Attends continuing education offerings Supports and assists management team with department projects. Assist in maintenance of budgetary data for each clinical trial. Assist in planning department coverage (patient clinic visits, data management, meetings. Education and/or Experience: Degree in the life sciences or health sciences such as Registered Nurse (R.N.), Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), other. Continuing education participation is expected, and research certification through a recognized national organization is encouraged. (SOCRA, ACRP) NIH protection of Human subjects on line course will be required annually IATA training will be required every 2 years LANGUAGE SKILLS: • Strong Verbal and written communication skills • Proficient in written and verbal English • Bilingual is a plus COMMENTS: This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time.

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.

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.