Clinical Research Associate jobs in Lemon Grove, CA

Arthrosi Therapeutics is a clinical stage company that is looking toexpand their Clinical Operations Team. The full-time Senior Clinical ResearchAssociate will be an integralmemberofthe Clinical Operations team whose work drives the company to meet critical milestones in the Arthrosi clinical development programs. The successful candidate will be self-motivated, comfortable working in a start-up environment where everyone pitches in to realize company goals, flexible, and innovative. Must have experience managing sites in late stage clinical trials, knowledge of clinical operations, ICH/GCP and FDA regulatory requirements. TravelRequirements: Travelcanrangefrom75%to 100% Responsibilities: Ensure compliance with study protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, CRA oversight visits, maintenance of study files, study close out, and retrieval of study materials. Support the sponsor and CRO study team in meeting study milestones (site activations, database lock, Investigator Meetings, etc.) Support centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues. CRA will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines, other regulatory requirements, and Arthrosi SOPs. Partner efficiently, effectively, and professionally with participating study sites and vendors to ensure smooth study conduct. Provide study and/or site specific progress updates to Clinical Operations Leads and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues. Provide oversight support in the timely recruitment of trial participants with subsequent efficient and effective data management. Provide monitoring oversight through review of monitoring schedules, metrics, and reports. Participate and support the study team and Investigator sites in audit preparation and follow-up activities, as needed Support the development of study documents and tools, including study logs, manuals, templates, newsletters, and other documents, as needed. Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans. Coordinate and conduct data reviews and data cleaning activities. Tracking of ancillary and investigational supplies, specimens and/or imaging. Ensure compliance with ICH/GCP and global regulatory guidelines. Must be willing to travel within the United States and internationally (as needed). Qualifications: Bachelors degree (or equivalent) in a relevant scientific field preferred. Minimum of 4-6 years of clinical trial experience including vendor management experience (e.g., imaging, central lab, IRT) and clinical monitoring in pharmaceutical, biotech or CRO setting. Experience in late stage clinical trials, including global experience. Experience working in small/emerging biotech is ideal Willingness to be a team player and take on additional responsibilities as requested Thorough knowledge of drug development, clinical operations processes and procedures according to ICH/GCP and other regulatory guidelines. Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint. Able to recognize need(s), find solutions, and take initiative to address in pro-active manner. Strong organizational, time management, skills. Excellent communication skills, both oral and written. Strong collaborator with demonstrated record of success in a cross-functional team and fast-moving environment. Arthrosi Therapeutics is an equal opportunity employer. All applicants will be considered foremployment without attention to the following: race, color, sex, sexual orientation, gender,gender identity, religion, national origin, citizenship and/or immigration status, pregnancy,genetic information including family medical history, physical or mental disability, child orspousal support withholding, military or veteran status, medical condition, marital status, AIDS/HIV, natural hair styles, political activities or affiliations, domestic violence, assault, orstalking victim status, application for or enrollment in Medi-Cal, lawful conduct occurringduring nonworking hours away from the employers premises, credit report or creditinformation, prior non-conviction arrest record, and any other protected class, in accordancewith applicable federal, state, and local laws.

The position of Cardiovascular Clinical Research Coordinator facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. Responsibilities Include: Promotes the ethical conduct of research. Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Schedules research subject appointments and serves as the patient liaison to the PI and other participating physicians. Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections. Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process. Coordinates and attends (SIV) site initiation visits, monitor visits, study termination visits. Completes case report forms in timely manner. Extracts data from research subject charts in a timely manner. Coordinates the completion of all protocol required forms by the investigator during study visits. Responds to data clarification requests in a timely manner. May attend investigator meetings in person or remote and report pertinent information back to research team members. Coordinates with investigators to help ensure that clinical research and related activities are performed in accordance with Federal regulations, sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around tasks related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training. Maintains weekly subject screening logs. Promptly report protocol deviations to sponsor/regulatory coordinator(s). Assess whether protocol deviations meet IRB requirements for promptly reportable information with regulatory coordinator(s). Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors. Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. Cooperates with sponsor on compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. Properly documents study visit tasks in the form of a research note. Ensures that all materials for each clinical trial protocol are available for subject enrollment. Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data. Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Establishes and organizes study files, study specific source documentation and other materials as required. Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, sponsors, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures. Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer. May perform other job-related duties as requested or required. Ability to perform intramuscular injections, venipuncture, peripheral intravenous lines, collect biological specimens and administer medications via all routes. Use of standard patient care equipment such as 12-lead ECG, pulse oximeter, blood pressure monitor, thermometer, IV pumps, & centrifuge. Knowledge of medications, indications, dosage ranges, side effects, and potential toxicity. Job Type: Full-time Salary: $37.00 - $45.00 per hour Benefits: 401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Schedule: 8-hour shift Monday to Friday Education: Active State of California Nursing License (RN) or Active State of California Licensed Vocation Nurse (LVN) (Required) Associate or Bachelor degree (Required) License must be free from any disciplinary actions. Experience: Two years' experience in a clinical research setting (preferred), working as a coordinator on Industry-Sponsored clinical trials. Cardiac Research experience is preferred, but not a requirement. Six months or more of active nursing experience. Cardiac Nursing experience is preferred, but not a requirement. Annual TB/Immunization Clearance required for Hospital Badge. Documentation of current, negative TB (Tuberculosis) Test within past three months OR documentation of negative chest x-ray within six months (if individual has a positive history). Badge Immunization Requirements include the following. Proof of Influenza Immunization during Flu Season (November - March) and/or declination form. Proof of two doses for the following Immunizations: Measles, Mumps, Rubella and Varicella (OR) positive titers. Proof of Tdap Immunization given within the last ten years. Proof of at least one dose of any COVID-19 immunization series. GCP (Good Clinical Practice) Certification within the last two years (preferred). If the certificate is not current, testing will be performed after hire before participation on any study protocol can occur. IATA Dangerous Goods Certificate within last two years (preferred). If the certificate is not current, testing will be performed after hire before participation in any study protocols with laboratory testing can occur. Primary Work Location: Kearny Mesa Office & Sharp Memorial Hospital

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. * Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team * Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials * Ensures consistency across studies and provide oversight of all clinical studies within assigned area * May serve as a Clinical Trial Lead or Co-Lead as needed * May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities * Serves as a key cross functional collaborator; initial point of escalation cross functions Key Responsibilities * Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical development and lifecycle planning * Lead implementation of assigned clinical development and/or lifecycle plans * Maintain an advanced understanding of all protocols within assigned Program * Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members * Represent Clinical Science Team on the Program Team as appropriate/requested * Support resourcing and budget planning activities for team * Review and present data and information to external investigators and internal stakeholders as needed * Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice * Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management * Author/Review abstracts/publications * Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as: * Evaluation of innovative trial designs * Protocol and ICF development * Site-facing activities * CRA training materials * Data quality activities; ensure consistent, quality data review across trial teams * Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities * Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Qualifications & Experience * Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) Experience Requirements: * 5+ years of experience in clinical science, clinical research, or equivalent * Experience in driving, managing and collaborating in a team/matrix work environment * Recognized internally and externally as a Therapeutic Area and Functional expert * Preferred experience in Neuroscience and/or Psychiatric Key Competency Requirements: * Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations * Ability to plan and manage * Advanced ability to analyze, interpret, and present data * Advanced knowledge and skills to support program specific data review, trend identification, data interpretation * Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements * Advanced medical writing and presentation skills * Ability to self-supervise, and act independently to identify/resolve program level issues * Proficient critical thinking, problem solving, decision making skills * Effective planning and time management * Advanced verbal, written and interpersonal skills (communication skills) * Adaptable and analytical * Strong presentation skills / leadership presence * Commitment to Quality * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism * Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) * Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools * Travel Required * Domestic and International travel may be required. Travel Required * Domestic and International travel may be required. The starting compensation for this job is a range from $182,000-$257,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #li-hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

The Global Clinical Scientist, Clinical Development will have a key role in supporting the clinical development of seralutinib for the treatment of pulmonary arterial hypertension (PAH). This includes contributing and having day-to-day responsibilities related to the conduct of the Phase 3 PROSERA study in PAH. This role will work in conjunction with the Clinical Development Lead, Study Teams, CRO, Clinical Operations, and Medical Affairs teams to resolve site challenges, support recruitment efforts, answer protocol related questions during trial execution, and to assist in the ensuring that the clinical data as part of the phase 3 program is of the highest quality. Essential Duties and Responsibilities Provide day-to-day oversight on the global Phase 3 study in PAH partnered with the Clinical Operations Co-lead. Under Direction of the Program Clinical Development Lead, provide general clinical and scientific support in all aspects of the PAH Clinical Development program, including the design, preparation, general conduct, analyses, and reporting of the clinical studies. Review and input on clinical and regulatory documents e.g. clinical study reports Participate in authorship of clinical/regulatory documents including clinical development plans, investigator brochures, safety risk management plans, PIPs and regulatory briefing packages. Review data listings to ensure the data is of the highest quality. Cultivate strong relationships and robust communication among the clinical study/project team and the development organization. Participate in weekly meetings with clinical operations, CRO, others, as a Clinical Development representative Liaise with other Gossamer Bio functional areas as needed to support the clinical study and PAH program. Provide support for the GB002 clinical development plan for PAH incorporating pre-clinical, clinical, regulatory, operational, biometric, CMC, and commercial strategies in accordance with corporate objectives. Provide feedback on specific sites and regions, and therapeutic area guideline trends to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification. Leverage relationships to ensure interest and commitment from clinical investigators for study enrollment and open communication regarding feedback to Gossamer. Identifies potential issues and leads contingency planning efforts; leads team problem solving efforts and applies decision-making tools and techniques, driving teams to make effective and efficient decisions. Contributes to the analysis and summary of the clinical findings from studies to support decisions regarding safety and efficacy i.e. study documents, clinical study reports, regulatory documents, or publications for some documents and sections, may function as the primary author as the subject matter expert. Conduct site visits with investigators and study staff (when appropriate) to foster relationships, ensure study conduct is of high quality and consistent with expectations established at study initiation. Support clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). JOB QUALIFICATIONS Advanced Degree in Life Sciences (PhD, Pharm D, or MS) 3-5+ years of experience in clinical science, clinical research, or equivalent. Therapeutic expertise in pulmonary arterial hypertension (PAH), pulmonary hypertension in interstitial lung disease (PH-ILD), idiopathic pulmonary fibrosis (IPF), or rare diseases. Broad knowledge of the drug development process including early and late phase development Experience in data analysis and utilizing Excel and power point Experience in leading Phase 2 and Phase3 studies and study teams Experience in writing and editing scientific and regulatory documents including clinical protocols and regulatory documents. Advanced analytical and influencing skills and proficient at data interpretation. Experience in conducting literature searches and synthesizing the information. Expert understanding of global clinical study design and drug development processes Strong understanding of GCP and ICH Guidelines Excellent interpersonal skills; able to work independently and collaboratively; exercise sound judgment, escalate issues when necessary, and motivate team members. Experience in presenting at both internal and external meetings. Office Environment based in San Diego, CA or Remote. Up to 30 % travel required as needed to support clinical study/program. Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment. The expected salary range for this position is $183,000 to $230,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below: Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit ******************************************************* California Consumer Privacy Act (CCPA) Notice for California Residents: This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller. Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller's Privacy team can be contacted at privacy@gossamerbio.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.

The Global Clinical Scientist, Clinical Development will have a key role in supporting the clinical development of seralutinib for the treatment of pulmonary arterial hypertension (PAH). This includes contributing and having day-to-day responsibilities related to the conduct of the Phase 3 PROSERA study in PAH. This role will work in conjunction with the Clinical Development Lead, Study Teams, CRO, Clinical Operations, and Medical Affairs teams to resolve site challenges, support recruitment efforts, answer protocol related questions during trial execution, and to assist in the ensuring that the clinical data as part of the phase 3 program is of the highest quality. Essential Duties and Responsibilities Provide day-to-day oversight on the global Phase 3 study in PAH partnered with the Clinical Operations Co-lead. Under Direction of the Program Clinical Development Lead, provide general clinical and scientific support in all aspects of the PAH Clinical Development program, including the design, preparation, general conduct, analyses, and reporting of the clinical studies. Review and input on clinical and regulatory documents e.g. clinical study reports Participate in authorship of clinical/regulatory documents including clinical development plans, investigator brochures, safety risk management plans, PIPs and regulatory briefing packages. Review data listings to ensure the data is of the highest quality. Cultivate strong relationships and robust communication among the clinical study/project team and the development organization. Participate in weekly meetings with clinical operations, CRO, others, as a Clinical Development representative Liaise with other Gossamer Bio functional areas as needed to support the clinical study and PAH program. Provide support for the GB002 clinical development plan for PAH incorporating pre-clinical, clinical, regulatory, operational, biometric, CMC, and commercial strategies in accordance with corporate objectives. Provide feedback on specific sites and regions, and therapeutic area guideline trends to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification. Leverage relationships to ensure interest and commitment from clinical investigators for study enrollment and open communication regarding feedback to Gossamer. Identifies potential issues and leads contingency planning efforts; leads team problem solving efforts and applies decision-making tools and techniques, driving teams to make effective and efficient decisions. Contributes to the analysis and summary of the clinical findings from studies to support decisions regarding safety and efficacy i.e. study documents, clinical study reports, regulatory documents, or publications for some documents and sections, may function as the primary author as the subject matter expert. Conduct site visits with investigators and study staff (when appropriate) to foster relationships, ensure study conduct is of high quality and consistent with expectations established at study initiation. Support clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). JOB QUALIFICATIONS Advanced Degree in Life Sciences (PhD, Pharm D, or MS) 3-5+ years of experience in clinical science, clinical research, or equivalent. Therapeutic expertise in pulmonary arterial hypertension (PAH), pulmonary hypertension in interstitial lung disease (PH-ILD), idiopathic pulmonary fibrosis (IPF), or rare diseases. Broad knowledge of the drug development process including early and late phase development Experience in data analysis and utilizing Excel and power point Experience in leading Phase 2 and Phase3 studies and study teams Experience in writing and editing scientific and regulatory documents including clinical protocols and regulatory documents. Advanced analytical and influencing skills and proficient at data interpretation. Experience in conducting literature searches and synthesizing the information. Expert understanding of global clinical study design and drug development processes Strong understanding of GCP and ICH Guidelines Excellent interpersonal skills; able to work independently and collaboratively; exercise sound judgment, escalate issues when necessary, and motivate team members. Experience in presenting at both internal and external meetings. Office Environment based in San Diego, CA or Remote. Up to 30 % travel required as needed to support clinical study/program. Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment. The expected salary range for this position is $183,000 to $230,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below: Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit ******************************************************* California Consumer Privacy Act (CCPA) Notice for California Residents: This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller. Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller's Privacy team can be contacted at privacy@gossamerbio.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.

Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company's lead therapeutic, ADI-PEG 20, is a novel biologic in late-stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including mesothelioma, sarcoma, melanoma, acute myeloid leukemia and others. We are seeking an experienced, independent clinical scientist professional with strong analytical skills and business acumen. The successful candidate will be a member of the Clinical Affairs group, working closely with the clinical and research groups and with senior management. The candidate will have relevant industry experience and should be familiar with current oncology treatment modalities, approaches to clinical and pre-clinical drug development, and regulatory and operational requirements. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable and willing to take on additional responsibilities as required. Responsibilities: Contributes to clinical and pre-clinical program development strategy and execution Analyzes and interprets study data, and prepares scientific reports and presentations Contributes to and authors strategic documents including pre-clinical and clinical sections of regulatory documents such as Investigator's Brochures, IND submission documents, study protocols, statistical analysis plans, responses to Health Authority questions Contributes to study-related advisory boards and investigators' meetings Manages collaborations with external groups Leads translational special interest projects Contributes to the development of abstracts, presentations, and manuscripts Assists with design, development and implementation of training programs for more junior colleagues Assists with clinical site evaluation

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Azenta Inc.At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and IntegrityJob TitleStudy ManagerJob Description Position Title: Study Manager Location: South Plainfield, NJ Shift: M-F 9am-5pm Intro At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally. How You'll Make an Impact The Study Manager acts as the main liaison between our diverse customer base and our extensive lab team, providing a fast-paced learning environment for the scientist who wants to enter the booming genomics market on our fun team. We offer a competitive compensation package in an engaging environment that promotes open critical thinking and change. What You'll Do Subject matter expert on next generation sequencing (NGS) services as provided by Azenta Life Sciences. Participate in scheduled teleconferences alongside our vast Sales network to provide technical consultations. Create quotes for customers with information received from technical consultations, email, and other customer touchpoints. White-glove project management for ongoing work; this involves communicating project updates, providing technical advice, post-delivery support, and regular reviews, as required. Troubleshoot experimental design and NGS applications while recommending options to our customers. Document and provide feedback to Marketing, Sales, and Process Development teams to improve value propositions, brand awareness, and market share. Train internal teams including Sales and Marketing on NGS services and solutions. Promote NGS business by visiting prospective and current customers, attending vendor shows and conferences, and providing technical webinars and poster presentations. Must be onsite at least 4 days per week to support in-person team collaboration. What You'll Bring Master's degree in Biological Sciences required. Experience with NGS platforms such as Illumina NovaSeq, PacBio and/or 10x Genomics preferred 2+ years of hands-on Next Generation Sequencing experience, both wet and dry lab preferred Project management experience preferred EOE M/F/Disabled/VET If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ************************ for assistance. Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.

Azenta Inc. At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity Job Title Study Manager Job Description Position Title: Study Manager Location: South Plainfield, NJ Shift: M-F 9am-5pm Intro At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally. How You'll Make an Impact The Study Manager acts as the main liaison between our diverse customer base and our extensive lab team, providing a fast-paced learning environment for the scientist who wants to enter the booming genomics market on our fun team. We offer a competitive compensation package in an engaging environment that promotes open critical thinking and change. What You'll Do * Subject matter expert on next generation sequencing (NGS) services as provided by Azenta Life Sciences. * Participate in scheduled teleconferences alongside our vast Sales network to provide technical consultations. * Create quotes for customers with information received from technical consultations, email, and other customer touchpoints. * White-glove project management for ongoing work; this involves communicating project updates, providing technical advice, post-delivery support, and regular reviews, as required. * Troubleshoot experimental design and NGS applications while recommending options to our customers. * Document and provide feedback to Marketing, Sales, and Process Development teams to improve value propositions, brand awareness, and market share. * Train internal teams including Sales and Marketing on NGS services and solutions. * Promote NGS business by visiting prospective and current customers, attending vendor shows and conferences, and providing technical webinars and poster presentations. * Must be onsite at least 4 days per week to support in-person team collaboration. What You'll Bring * Master's degree in Biological Sciences required. * Experience with NGS platforms such as Illumina NovaSeq, PacBio and/or 10x Genomics preferred * 2+ years of hands-on Next Generation Sequencing experience, both wet and dry lab preferred * Project management experience preferred EOE M/F/Disabled/VET If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at ************************ for assistance. Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Thorough understanding of study protocol and manuals. Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. Participate in monitoring activities to achieve study milestones. Utilize internal and study specific software and tools. Assist in training new monitors on study specific or onsite procedures as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Experience in AD research is preferred. Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.02 - $57.51. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country's regulation pertaining to clinical trials and monitoring. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************

COMPANY OVERVIEW: At Alliance Clinical Network we're people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day. SUMMARY: We are seeking a Sr Clinical Research Coordinator to join ACN and lead our clinical operations team at our San Diego location. In this role, you'll have the opportunity to train and support staff managing multiple studies. If you're an enthusiastic, detail-orientated lead CRC looking for your next step - we'd like to meet you. ESSENTIAL DUTIES AND RESPONSIBILITIES: Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. Manage, train and support clinical site staff. Review, comprehend and communicate study protocols. Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV). Assist CRC team as requested to facilitate research and business needs. Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP's. Ensure all data is entered into sponsor's data portal and all queries are resolved in a timely manner. Work closely with CRO/CRA and IRB. Perform administrative tasks such as ordering supplies and equipment for the study. Manage all required study start up documentation, training and timelines on assigned study protocols. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPREIENCE: Associate's degree and/or completion of accredited healthcare certification program, required. Comfortable stepping into a leadership role. 2+ years' experience in clinical research, required. 2+ years' experience working as a Clinical Research Coordinator, preferred. Comprehensive knowledge of FDA, GCP & confidentiality. Exceptional attention to detail and organization. Excellent written and communication skills. A proven ability to multi-task in a rapidly changing environment. BENEFITS: 401 (k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more!

Title & Department: Undergraduate Studies Coordinator; College of Arts and Sciences Posting # 5231 Department Description: As the liberal arts heart of the University of San Diego, the College of Arts and Sciences is filled with students who are versatile and multi-talented. No matter their major, graduates from the college are equipped with transferable skills that benefit them wherever their professional and personal ambitions lead. Founded in 1949, the college has a rich history of providing the core curriculum for every undergraduate USD student, a tradition that continues today. By offering 32 majors, 38 minors, one certificate and three graduate programs, the college is where undergraduate students begin and graduate students refine their paths towards academic excellence and personal achievement. University Description: The University of San Diego, an engaged and contemporary Catholic institution, was founded by the Diocese of San Diego and the Society of the Sacred Heart in 1949. Governed by an independent board of trustees since 1972, USD remains committed to a liberal arts education grounded in the Catholic intellectual tradition and the pursuit of truth, goodness and beauty. Inspired by this centuries old tradition of Catholic higher education, the University welcomes people of all faith traditions and any, or no, religious background. The future success of USD relies on the contributions of those who seek to foster the development of engaged global citizens and an earnest confrontation of humanity's urgent challenges. Detailed Description: Performs detailed, complex coordination, and administrative tasks for the College of Arts and Sciences Dean's Office. Assists the Associate Dean and Assistant Deans of Undergraduate Studies in all aspects. Is responsible for coordination, communication, and marketing activities and events for Learning Communities and Undergraduate Studies. Liaises with other offices on campus to program. Collaborates with the Undergraduate Studies Learning Communities teams to support faculty, students, and staff in the Living Learning (LLC) and Transfer Learning Communities (TLC) programs. Duties and Responsibilities: Undergraduate Studies Coordination: Coordinates, with the Associate Dean, academic onboarding for incoming students in fall and spring. Coordinates and attends meetings with campus partners for first-year and transfer processes throughout the entire year. To support first year experiences for students, coordinates LLC course and housing placements, with Residential Life. Maintains and updates new student advising questionnaires for academic onboarding. Communicates with faculty advisors and professional advisors in the undergraduate units throughout the first-year scheduling process. Creates and maintains manuals for faculty for summer scheduling and LLC advising. Implements plans faculty development training and other events co-sponsored by Undergraduate Studies and Learning Communities offices. Supports Associate Dean with faculty applications and tracking compensation for LC courses and Faculty Integration Coordinators. Supports Associate Dean administratively with curricular and enrollment management, including Census tracking and LC courses. Oversees the input of data from Learning Community Surveys into Qualtrics. Undergraduate Student Support: Maintains the official university database for AP/IB/CLEP scores, including updating tables and websites. Coordinates and administers official notifications to students in mail merges, including highly confidential letters such as disqualification, academic notice / probation, reinstatement, readmittance, and academic integrity letters. Coordinates hearings for grade grievances and academic integrity in collaboration with the Special Assistant to the Associate Dean. Maintains the College's online database (i.e., Maxient) for Academic Integrity. Surveys faculty for the last date of class student attendance for tuition refunds, Faculty Alert Outreach (FAO), wellness-checks, and general academic support. Events and Communication: Plans, implements, and attends Undergraduate Studies, College of Arts and Sciences, and College Academic District events connected to the mission in collaboration with the Associate Dean and Assistant Deans. Schedules meeting for the Associate Dean and Assistant Deans, as needed. Supports the Associate Dean and the Creative Manager who organize the annual New Student Convocation. Administrative Support: Manages communication with other campus and community partners on campus with collaborative efforts in Undergraduate Studies from Advisors, Assistant, and Associate Deans. Review and manage incoming emails from students and forwards to appropriate partner. Coordinates communication efforts for the College Dean's Office. Supports the College of Arts and Sciences Dean's Office, the College Academic District, and the Learning Communities Office as needed. In collaboration with the Dean's office executive assistant, supports the reception process and front desk staffing, as needed. Supervises the training of work study students so that they are familiar with Department, University and the College Dean's Office policies and procedures. Performs other duties as assigned. Special Conditions of Employment: Background check: Successful completion of a pre-employment background check. Degree Verification Requirement: Persons offered employment in this position will be required to provide official education transcripts for degree verification purposes. Job Requirements: Minimum Qualifications: Bachelor's Degree and two years of office work experience OR High School Diploma and four years of office work experience required Above experience must include one year of experience in general office coordination and/or event planning. Preferred Qualifications: Advanced computer skills in Microsoft Office (all applications), website maintenance, and Salesforce preferred. Performance Expectations - Knowledge, Skills and Abilities: Take responsibility for dealing appropriately with problems, exercising independent judgment, and making decisions while engaging with diverse personalities and demographics. Implement skills for organizing and managing concurrent projects, prioritizing workload, and meeting tight deadlines. Excellent professional written, verbal, proofreading, and communication skills. Develop and use empathetic listening skills, communicate with clarity and maintain an attitude that conveys respect, assistance, honesty and resourcefulness. Cooperate as a team to support the mission of Undergraduate Studies and the College of Arts and Sciences Dean's Office. Demonstrate flexibility and versatility to respond to evolving work situations. Establish and maintain strong working relationships with colleagues, staff, administrators, students, and the general public. Knowledge of and ability to learn multiple software platforms--SalesForce, Cascade, Banner, Excel, project management software, MySanDiego portal, Qualtrics, Maxient. Thorough knowledge of general office practices and procedures. Posting Salary: $26.00 - $33.00 per hour; Excellent Benefits The University of San Diego offers a very competitive benefits package including; medical, dental, vision, a retirement contribution given to you by the University, and access to on-campus Fitness Centers. Please visit the benefits section of our website to view all of the perks and benefits that USD has to offer. USD: Human Resources: Benefits The salary range provided in this posting reflects what we reasonably expect to pay for this position. Actual compensation offered or earned is dependent on experience, education and other factors including departmental budget. Special Application Instructions: Resume Required, Cover Letter Preferred Click the 'Apply Now' button to complete our online application and, for full consideration, please upload a resume to your application profile for the hiring managers' review. You are also strongly recommended to upload a cover letter to your application profile for the hiring managers' review. If you have any questions or difficulties please contact the Employment Services Team at *****************. Additional Details: Hours: 37.5 hours per week Closing date: Open until filled Note: External job postings will be up for at least three days. After that time, applications will be reviewed by the hiring manager/committee throughout the posting period. A candidate may be selected at any time which could then close this posting on a date earlier than listed. The University of San Diego is a smoking and tobacco-free campus. For more information, visit ***************************

Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees: A range of PPO and HMO medical plans PPO and HMO dental plans Vision coverage, long term disability plan, and life/AD&D coverage 401k plan Paid holidays and paid time off A welcoming work environment We're looking for a bright, talented new team member to be a part of our story. Check out this current opening and if you think you may be a fit for the role, please apply. The Role Artemis is looking for a Clinical Research Coordinator II for the San Diego office. Under the supervision of the Site Director, the Clinical Research Coordinator II is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Clinical Research Coordinator II manages study conduct from planning through study closeout. Position Type: Full Time Pay Range : $68,640 - $75,000/year Location: San Diego-no remote work Travel: 0% Work Schedule: Monday & Thursday - 8:30am-5pm / Tuesday, Wednesday, and Friday 7:00am-3:30 pm Responsibilities In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending Investigator Meetings Providing the highest level of care for study patients and delivering excellent customer service to the Pharmaceutical clients Assist with lab draws, processing and shipping Qualifications Bachelor's Degree preferred Minimum three plus (3+) years of experience as a Clinical Research Coordinator required Medical assistant or phlebotomist required Commitment and ability to deliver excellent customer service Excellent communication, punctual and responsible Extremely well organized Excellent verbal and written communication skills Trustworthy, reliable; attentive to details Mature and pleasant demeanor Willingness to learn new tasks and grow with the company

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We are recruiting to fill a position to lead business development activities for a small government contracting firm focused on IT Services and Cyber Security for clients in Civil and DoD markets. We can't sponsor H1B. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. Arcetyp LLC is looking for an experienced Clinical Research Coordinator. This role will be responsible for performing the following tasks: DUTIES AND RESPONSIBILITIES: Coordinates and participates in clinical research studies by performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Coordinates and implements procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Assists in the determination of guidelines for the collection of clinical data or administration of clinical studies. EDUCATION AND YEARS OF EXPERIENCE: Bachelor's Degree from an accredited college or university and a minimum experience of 2 years as a Clinical Research Coordinator within the past five years OR current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), OR Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) OR the Society of Clinical Research Associates (SoCRA). Minimum of 2 to 4 years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience. QUALIFICATIONS: Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge. Ability to communicate effectively, both orally and in writing. Possess effective organizational and analytical skills with ability to work independently and in a team environment. Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program. Candidate must possess active/current secret security clearance. Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date Min. Citizenship Status Required: U.S Citizenship. Physical Requirement(s): None Location: Okinawa, Japan COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.

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:Responsible for overseeing aspects of bioanalysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Work with Preclinical Operations to establish contracts and work orders for bioanalytical projects. Work with Clinical Pharmacology, Clinical Operations to plan and track bioanalytical method development, validation, and sample analysis to support study initiation, execution, and reporting. Ensure CROs capture and deliver important expectations and agreed-to tasks in support of Neurocrine's clinical development programs _ Your Contributions (include, but are not limited to): Supporting all aspects of bioanalytical outsourcing (custom reagent preparation, method development, validation, and sample analysis) at bioanalytical contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards for both small and large molecule. Oversee sample transfer and tracking from clinical sites or central lab to bioanalytical CROs Ensure CROs are provided with requisite supplies and information for assay development and to conduct sample analysis, including provision of reference and internal standards, CoA recertification, and statement of work completion Review bioanalytical study plans, study protocols, bioanalytical data, and bioanalytical reports to ensure regulatory alignment Plan and track bioanalytical method development, validation, and sample analysis activities to meet data requirements in accordance with study protocols and team timelines Attend regular meetings with CROs to facilitate updates. Capture important expectations and agreed to tasks in post-meeting minutes and share minutes with CROs and relevant NBI personnel Work with Preclinical Operations to establish contracts and work orders for bioanalytical projects Provide routine status updates to NBI Clinical, Accounting, and, Analytics and Data Sciences colleagues Review data transfer protocols, ensure proper data format, investigate data discrepancies and support data consolidation Other tasks as assigned Requirements: BS/BA degree in science related field or similar and 2+ years of pharmaceutical/biotech experience. Experience in managing clinical Contract Research Organizations, preparation of INDs, CTDs, NDAs, and MAAs and working in a cross functional team and matrix environment. Experience developing small/large molecule compounds for CNS indications and silico modeling and simulation tools is beneficial MS/MA degree in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 1+ years of similar experience noted above Experience supporting the development, validation, and troubleshooting of bioanalytical methods and clinical sample analysis in one or more of the following disciplines: small molecule, peptides, antibodies, and gene therapy Knowledgeable on current regulatory guidance/regulations (FDA/ICH M10) Demonstrates solid level of understanding project/group goals and methods Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes Moderate knowledge of scientific principles, methods and techniques in small or large molecule bioanalysis Detail oriented yet can see broader picture of scientific impact on team Strong project management skills Excellent computer skills Ability to meet multiple deadlines, with a high degree of accuracy and efficiency Strong project management skills Excellent problem-solving and analytical thinking skills Strong written, presentation, and verbal communication skills Proactive, innovative, with good problem-solving skills Ability to work as part of a team #LI-OB1 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.

CAMRIS seeks a Clinical Research Coordinator II to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by overseeing and administering research studies and ensuring compliance with study protocols and regulatory requirements. The role involves assisting with planning, recruiting, and coordinating research subjects, as well as serving as a primary liaison for projects, along with the principal investigator (PI). The Clinical Research Coordinator II oversees staff services, maintains record-keeping systems, and ensures seamless study operations. This position provides an exciting opportunity to lead critical research initiatives in infectious diseases, supporting military health and global public health efforts. The Clinical Research Coordinator II will help ensure the success of clinical trials and research projects at NHRC. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. Responsibilities Study Administration and Oversight: Lead research studies and associated activities to ensure adherence to study protocols, timelines, and regulatory standards. Monitor, record, and report study progress in close coordination with the PI and study team and assist in study planning to meet milestones and objectives. Ensure pre-established work scope and study protocols are followed throughout the study lifecycle. Regulatory Compliance: Ensure all activities comply with Institutional Review Board (IRB) requirements and other regulatory standards. Prepare, obtain, and track agreements and approvals. Prepare and submit IRB applications, amendments, and continuing reviews. Maintain accurate study documentation and ensure that study protocols are adhered to throughout the study lifecycle. Prepare for and participate in monitoring visits, audits, and inspections by regulatory agencies. Participant Recruitment and Coordination: May recruit, screen, and coordinate research subjects as per study protocols. May obtain informed consent and schedule subject visits. Ensure compliance with study requirements. Frequent and clear communication with sites to ensure all aspects of the study are communicated and the sites remain engaged. Liaison and Communication: Serve as the primary administrative point of contact between investigators, research staff, and external stakeholders. Facilitate communication between clinical teams, sponsors, and regulatory authorities to ensure smooth study execution. Administration and Staff Services: Serve as an administrative point of contact between investigators, research staff, and external stakeholders. Facilitate communication between study teams, sponsors, and regulatory authorities to ensure smooth study execution. Sample Collection, Data Management, and Reporting: Monitor studies to ensure samples are collected per study requirements. Supervise data collection and entry to ensure accuracy and completeness. Address data queries and resolve discrepancies in accordance with Good Clinical Practice (GCP) guidelines. Prepare regular progress reports and assist with study-related presentations. Perform other duties as assigned. Qualifications Required US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. A BA/BS in sciences, public health, epidemiology or equivalent PLUS one to two years of clinical research and management experience OR 8+ years of research experience, including two years of research management experience. Familiarity with surveillance-based research, IRB submissions and reporting processes. Strong understanding of research principles, study design, and regulatory requirements. Familiarity with/electronic IRB (eIRB) systems. Proactive problem-solving skills, organizational, communication, and leadership skills. Ability to work both independently and collaboratively in a research setting. Ability to manage multiple projects and prioritize tasks in a dynamic research environment. Ability to work in a fast-paced environment and able to balance completing priorities and deadlines. Ability to present studies to collaborators and staff. Preferred Familiarity with Tableau and Power BI experience is desired. Experience with infectious disease studies or military health research. Proven experience in supervisory roles within clinical and surveillance studies. Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions. Physical Demands Constantly conduct sedentary work that primarily involves sitting/standing. Occasionally conduct light work that includes moving objects up to 20 pounds. Occasionally conduct medium work that includes moving objects up to 50 pounds. Occasionally push or pull less than 25 pounds. Occasionally reach above shoulder level. Constantly use both hands. Occasionally stand or walk for more than 25 minutes. Occasionally bend, reach, or twist repeatedly. Occasionally kneel, squat, or stoop. Occasionally crawl or climb. Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity. Physical Activities Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like. Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces. Occasionally move about to accomplish tasks or move from one worksite to another. Constantly communicate with others to exchange information. Constantly assess the accuracy, neatness, and thoroughness of the work assigned. Environmental Conditions Occasional work in low temperatures. Occasional work in high temperatures. Occasional work in outdoor elements, such as precipitation and wind. Occasional work in noisy environments. Occasional work in small and/or enclosed spaces. Occasional work in environments where no adverse environmental conditions are expected. PPE and Chemical Requirements Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes. Occasionally wear a lab coat. Occasionally wear a disposable dust/surgical mask. Occasionally wear respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA. Please submit your resume online at *************** CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, political affiliation, marital status, military status, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability. Employment is contingent upon successful completion of a secret-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

Biotheranostics, a Hologic company, develops and provides molecular-based diagnostic, prognostic, and predictive tests that support physicians in the individualized treatment of cancer patients. will r eport to the Clinical Pathology Supervisor and will support the clinical review process for the Breast Cancer Index (BCI) test in compliance with policies, procedures, and regulations. Key Responsibilities: Reviews and analyzes all documents (pathology reports, chart notes, and imaging reports) to confirm accuracy of clinical data and eligibility for BCI testing The data being reviewed is complex medical and clinical information and will require knowledge of medical terminology and high attention to detail Identifies discrepancies in clinical data or documents and communicates those discrepancies in a clear and effective manner with internal staff (and potentially to external clients as needed) Ensures BCI orders are reviewed in a timely manner and prioritizes Rush and Follow-Up clinical reviews Determines which specimen is most appropriate for testing and indicates to Client Services when to request the tissue specimen from pathology Identifies orders that are not clinically validated for BCI and need to be Cancelled Escalates issues as needed to Clinical Pathology Supervisor or onsite Pathologist for resolution Focuses on maintaining accurate and efficient clinical reviews Participate in internal audit performance and analysis of the Breast Cancer Index Clinical review process Performs other duties, as assigned Qualifications: Bachelor's degree in the Sciences preferred, Associates degree (at minimum) required 1+ years of laboratory experience preferred Analytical, good problem-solving skills, and has a strong detail-oriented approach to performing tasks Proficient knowledge and experience with Microsoft applications (such as Word, Excel and PowerPoint) and technologically savvy Professional and courteous demeanor as you will be the main POC for BCI clinical related questions Works well in a cross-functional team environment with meticulous attention to detail, strong data entry skills, excellent communication skills, and strong organizational skills High level of integrity in resolving discrepancies and proactively improving operational efficiencies The annualized base salary range for this role is $55,600 - $84,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

Profound Research: Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research. Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values: Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Why this Role Exists The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values. Responsibilities -Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements -Bachelor's degree and 2 years relevant experience in the life science industry OR -Associate's degree with 4 years relevant experience in the life science industry OR -High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year -Clinical Research Coordinator experience -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens -Proficient ability to work independently, plan and prioritize with minimal guidance -Excellent attention to detail, organization, and communication with varied stakeholders -Ability to work as a team player with the ability to adapt to changing schedules and assignments Travel Requirements Daily commute to site(s) Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees: A range of PPO and HMO medical plans PPO and HMO dental plans Vision coverage, long term disability plan, and life/AD&D coverage 401k plan Paid holidays and paid time off A welcoming work environment We're looking for a bright, talented new team member to be a part of our story. Check out this current opening and if you think you may be a fit for the role, please apply. The Role Artemis is looking for a Clinical Research Coordinator II for the San Diego office. Under the supervision of the Site Director, the Clinical Research Coordinator II is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Clinical Research Coordinator II manages study conduct from planning through study closeout. Position Type: Full Time Pay Range : $68,640 - $75,000/year Location: San Diego-no remote work Travel: 0% Work Schedule: Monday & Thursday - 8:30am-5pm / Tuesday, Wednesday, and Friday 7:00am-3:30 pm Responsibilities In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending Investigator Meetings Providing the highest level of care for study patients and delivering excellent customer service to the Pharmaceutical clients Assist with lab draws, processing and shipping Qualifications Bachelor's Degree preferred Minimum three plus (3+) years of experience as a Clinical Research Coordinator required Medical assistant or phlebotomist required Commitment and ability to deliver excellent customer service Excellent communication, punctual and responsible Extremely well organized Excellent verbal and written communication skills Trustworthy, reliable; attentive to details Mature and pleasant demeanor Willingness to learn new tasks and grow with the company