Clinical research associate jobs in Petaluma, CA - 183 jobs

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Clinical Research Specialist 5 months with a possibility to extend Medtronic - Santa Rosa, CA Duties: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Assist in preparation of study materials and/or training. Interface with, and assure training of investigators, site staff, and Medtronic clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review). May arrange conference calls, staff meetings and training events. Assist data management group with review of clinical data/information and oversight of data correction. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. Must be willing to assist with other duties as needed such as filing and document tracking. Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. Qualifications Top 3 qualifications: Previous clinical research experience Ability to prioritize and strong critical thinking skills Attention to detail and strong communication skills Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 619-727-5167 ASAP! I want to know more about your preferences. If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!

+ Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an indication or across a program as required + Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study + Ensures alignment of regional deliverables with overall study goals + Contributes to the development of regional tools and leads the development of work instructions and SOPs as required **Essential Functions of the job:** **Regional Leadership** + Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study + Leads external vendors involved in study delivery on a regional level + Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional study team members + Displays therapeutic area knowledge and expertise **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these + Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study plans as required + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems and tools is entered and up to date + Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports + Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region + Manages the trial data collection process for the region, drives data entry and query resolution + As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads + Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point in time throughout the study life cycle + Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented + Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate + Collaborates with CST members and othercolleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies + Leads the development, optimization and review of work instructions and SOPs as required **Budget and Resources** + Works with the sourcing team to select and manage regional study vendors + Manages regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides performance feedback on team members as required + Mentors junior team members and might take on line management responsibilities as required **Computer Skills:** MS Office, Project Planning Applications **Other Qualifications:** + 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead in clinical functions + Experience as CRA is preferred **Travel:** Travel might be required as per business need **Education Required:** Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred _*exceptions might be made for candidates with relevant clinical operations experience_ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Role OverviewThe Clinical Trial Research Scientist evaluates clinical study protocols, trial designs, endpoints, statistical plans, and study results. This role emphasizes methodological rigor, documentation clarity, and accurate interpretation of safety and efficacy outcomes. What You'll Do- Review clinical trial protocols and identify methodological strengths or gaps - Analyze endpoints, inclusion/exclusion criteria, and study controls - Interpret trial results and summarize safety and efficacy findings - Validate statistical analysis plans for completeness and accuracy - Identify operational or scientific risks in trial execution - Support recurring evaluations of clinical documentation and study outputs What You BringMust-Have:- Experience in clinical research, biostatistics, or pharmaceutical science - Strong understanding of trial methodology and regulatory standards - Ability to interpret trial data and communicate findings clearly Nice-to-Have:- Experience with Phase I-IV trials or specific therapeutic areas

At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse Chronic Kidney Disease (CKD) pipeline of precision medicines. You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management. The Impact You'll Have You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include: * Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 CKD study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary. Will also help support Early Development studies in collaboration with Study Lead. * Site & Vendor Oversight: Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Study Lead) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. * Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs. * Supporting Key Study Materials: Assist in the design and development of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials. * Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners. * Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed. * Sample & Data Management: Work with study team to coordinate sample shipments, sample analysis, and data reconciliation efforts. * Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team. * Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) to optimize study execution. What We're Looking For We're looking for someone who's not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have: * A strong clinical operations background: Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment. * A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes. * Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track. * A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners. * Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms. * Flexibility and adaptability: You're comfortable working in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed. * Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary. * Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook). This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together - Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed - We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True - Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid #LI-Hybrid

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring a Patient Recruitment Manager to support our Flourish Research site in Walnut Creek, CA The Manager of Patient Recruitment is a dynamic, strategic, execution-oriented, and performance-driven sales leader assuming full responsibility for the achievement of study enrollment objectives. This leader consistently hits revenue targets by designing study enrollment strategies and directly implementing them with precision by effectively managing a team of recruiting representatives. The Manager is expected to effectively partner with corporate functions to drive high performance in the areas of patient lead generation, funnel conversion metrics, and patient experience. To cultivate and maintain a strong culture of accountability, the Manager employs a servant leadership style, exudes a deep commitment to achieving goals, and provides hands-on, data driven coaching to both recruiting representatives. Shift: On Site Monday-Friday, 8:30 AM - 5:00 PM Location: 2255 Ygnacio Valley Road, Suite M, Walnut Creek, CA 94598 Compensation: $80,000 - $95,000 Salary Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES Create and run strategic recruitment plans for all assigned studies. Achieve study enrollment goals and assigned revenue targets. Communicate and collaborate with corporate support functions (i.e. marketing, revenue operations, business development) regarding needs to effectively fill studies. Study leading and lagging indicators at individual and team level taking targeted action to improve areas of underperformance and/or prevent underperformance. Build and maintain a culture of accountability, collaboration, and results. Prioritize studies and execute patient routing accordingly to generate the best revenue results. Lead and manage patient recruiting representatives to achieve all assigned key performance indicators. Identify and implement coaching, training, and development programs to drive improvement in the call center team. Implement KPIs with support of leadership for direct reporting staff. Identify process and system improvement opportunities and partner with corporate support functions to drive improvement. Participate in sponsor relations and communications as needed. Maintain and manage all vendor relationships (i.e. uber, outsourced marketing/recruiting agencies etc.). Ensure all representatives appropriately document in the CRM and CTMS is entered correctly and with precision. Ensure patient enrollment teams adhere to the appropriate legal and ethical professional conduct standards. Manage community connections, coordinate events and establish new routes of community outreach. Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors. Additional duties as assigned by management. SKILLS Strong leadership and team management abilities. Impeccable organizational skills and attention to detail. Exceptional professionalism and patient-centered focus. Excellent communication and interpersonal skills to engage with clinicians, staff, and community partners. Ethical compass that compels honesty, accountability, and self-motivation. High-level critical thinking and problem-solving skills. Proficiency with computers, databases, and Microsoft Office Suite. Ability to thrive in a fast-paced, productive, and high-performing environment. QUALIFICATIONS Bachelor's Degree Required Minimum 2-3 years of experience in clinical research recruitment or related healthcare field, with at least 1 year in a leadership or supervisory role. Proven success developing and executing recruitment strategies. Proficient knowledge of medical terminology and clinical trial processes. Strong understanding of GCP regulatory requirements. Previous experience with electronic medical records and recruitment databases preferred. Excellent oral and written communication skills. Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.

The Homeless Services Clinic Coordinator in Oakland, Ca is responsible for overseeing the admin needs of clinics offered within homeless services programs. The HSCC plans programs clinic schedules, manages supplies and inventory, assists clinic and program providers to facilitate patient care, conducts patient outreach, oversees admin of contingency management, facilitates referrals, troubleshoots insurance eligibility issues, and provides patient health education. LifeLong Medical Care is a multi-site, Federally Qualified Health Center (FQHC) with a rich history of providing innovative healthcare and social services to a wonderfully diverse patient community. Our patient-centered health home is a dynamic place to work, practice, and grow. We have over 15 primary care health centers and deliver integrated services including psychosocial, referrals, chronic disease management, dental, health education, home visits, and much, much more. Benefits Compensation: $21 - $23/hour. We offer excellent benefits including: medical, dental, vision (including dependent and domestic partner coverage), generous leave benefits including ten paid holidays, Flexible Spending Accounts, 403(b) retirement savings plan. Responsibilities Essential Functions Conduct patient intakes, registers new patients, and maintains accurate medical records Register new patients and scan necessary documents in the Electronic Health Record Look up and enter insurance information into individual health records and trouble shoot eligibility issues Maintain up to date patient demographic and insurance information in agency clinic management and health record systems Maintain provider visit schedule of appointments and provide regular reminders to providers of their scheduled appointments Work with on-duty staff to conduct regular outreach effort to patients to and ensure patients attend scheduled appointments on time Manage patient flow during clinic hours, including check in and check out Assure that clinics have necessary supplies, that clinic facilities are set up prior to scheduled clinic time, and exam rooms are stocked appropriately prior to patient appointments Conduct regular inventory of clinic supplies, submit requisitions for supply orders, and assure out-of-date supplies are disposed of according to relevant agency guidelines Coordinate site waste disposal with appropriate vendors Maintain and record vaccine refrigerator and freezer temperature log Label and organize supplies appropriately to make sure they are retrievable Track patient encounters and enter charges for each completed encounter on a weekly basis Enter and track encounter and billing data to ensure clinic is meeting productivity targets Run insurance and check eligibility for every new patient, at patient intake, and once a month for all patients Assist patients whose Medi-Cal is no longer active or registered in Alameda County to submit applications and recertifications to renew or establish insurance and benefits Contact insurance providers or other funders to obtain authorizations to ensure reimbursement for services Coordinate with case managers, providers, and referral specialists to facilitate referrals for labs, diagnostic tests, specialty care, and follow up appointments Manage day-to-day operational aspects of contingency management and train staff on how to administer rewards Work with site staff to conduct regular outreach efforts to clients Participate in and help conduct group visits at each site Attend all meetings that are required for this position, take notes, and distribute notes to meeting attendees Qualifications Qualifications Commitment to the provision of primary care services for the underserved with demonstrated ability and sensitivity in working with a variety of people from low-income populations, with diverse educational, lifestyle, ethnic and cultural origins. Strong organizational, administrative and problem-solving skills, and ability to be flexible and adaptive to change. Ability to effectively present information to others, including other employees, community partners and vendors. Ability to seek direction/approval on essential matters, yet work independently with little onsite supervision, using professional judgment and diplomacy. Work in a team-oriented environment with a number of professionals with different work styles and support needs. Excellent interpersonal, verbal, and written skills. Conduct oneself in internal and external settings in a way that reflects positively on LifeLong Medical Care as an organization of professional, confident and sensitive staff. Ability to see how one's work intersects with that of other departments of LifeLong Medical Care and that of other partner organizations. Make appropriate use of knowledge/ expertise/ connections of other staff. Be creative and mature with a “can do”, proactive attitude and an ability to continuously “scan” the environment, identifying and taking advantage of opportunities for improvement.

Full-time Description The Clinical Research Coordinator (CRC) is the primary point of contact for the study patient and sponsor representatives. The CRC works closely with the Principal Investigator and Sub-Investigator to ensure the safety and well-being of the study patient is protected. CRCs are expected to maintain all documents, processes, and supplies for all assigned duties according to protocol. Essential functions: Study recruiting activity, including pre-screening, screening, and recruitment of patients. Obtains informed consent per ICH/GCP and site SOPs. Interviews and collects data from study patients. Creates and completes source documentation and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintains a thorough understanding of all data collection instruments and collects data accurately and according to protocol. Performs basic data gathering, EDC transcription, and manipulation of source documents. Maintains regulatory binders (ISF) with applicable documents and communicates effectively with study monitors (CRAs) during site visits and audits. Coordinates study visits and performs procedures such as AE collection, ConMeds, and eye pressure assessment. Schedules subject visits as needed and obtains vitals (height, weight, pulse, respiratory rate, blood pressure, etc.) and ECGs. Dispenses and collects study medication and provides accurate Investigational Product (IP) accountability. Reports temperature excursions in a timely manner. Collects and processes laboratory specimens for study participants according to protocol. Other responsibilities: Duties assigned by the Clinical Research Supervisor/Manager or Director of Operations. Requirements Skills Required: Computer literate and experience using EHR, MS Office suite, web browsing, email, and spreadsheets. Adaptable and able to learn quickly. Meticulous and detail oriented. Able to follow directions with minimal supervision. Excellent written and verbal communication skills. Excellent customer service skills. Takes initiative, able to see a task that needs to be completed and completes it. Must be able to multitask and able to handle a high volume of patients. Open to work a flexible work schedule. Experience preferred: 3-5 years as a clinical research coordinator. Additional past medical office experience. Preferred knowledge of the design ad conduct of clinical studies. Phlebotomy certification and experience preferred. Ophthalmology clinical research experience preferred. Education required or equivalent: Bachelor's degree preferred. Physical standards, including lifting and pushing requirements: Must be able to remain in a stationary position for 50% of scheduled shifts or more, be able to frequently move about the office to direct patients, access office supplies and equipment, and be able to lift up to 50 pounds. Must be able to communicate with patients to convey necessary medical and financial information and document accurately in EMR and practice management system. Travel requirements: Study-related travel, including travel to clinic locations as needed and sponsor-related travel (investigator meetings, training, etc.). Equipment: This position requires the use of telephone and office equipment such as computers, copier, fax machine, and scanner. Requires use of Microsoft Office products and occasional use of medical equipment such as exam chairs, imaging equipment, pharmaceutical refrigerators, and diagnostic testing equipment. Unique conditions of the position: OSHA Classification Category I. Job duties include exposure to blood, bodily fluids, or tissues. 2-year commitment preferred. Salary Description $67,800 - $88,400

Irvine Clinical Research is the largest independent clinical trial group on the West Coast. Most of our research is in neurology (Alzheimer's Disease treatment and prevention studies); we also conduct trials in psychiatry and obesity medicine. In this role, we are seeking CRCs with proven trial experience. Ideally, candidates will have worked as a primary coordinator on a high-enrolling and/or highly complex drug trial and produced quality work.Job Duties Manage daily operations for assigned clinical trial projects Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Cultivate enthusiastic and professional relationships with patients and sponsors alike Work closely with recruitment and prescreening teams to meet study enrollment goals Conduct diagnostic, efficacy, and safety assessments as needed Job Requirements Two (2) or more years of clinical research coordinator experience Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with CTMS A command of professional spoken and written English

**Overall Responsibilities:** + The Clinical Research Coordinator, under the oversight of the Clinical Trial Manager and PI, is responsible for independently conducting clinical research sessions with study participants. + These sessions will be conducted on-site in South San Francisco and virtually. **Top 3 Daily Responsibilities:** + Conduct Clinical Research Coordinator activities for assigned clinical research device studies including consenting participants, conducting study sessions, maintaining device accountability, and completing data entry into the Electronic Data Capture (EDC) system. + Maintain Investigator Site Files and support Sponsor eTMF Maintenance. + Coordinate study participant recruitment efforts and ensure participants are compensated for their study participation. **Mandatory:** **Education:** + BS/BA degree in life science, health science, RN, or related field. + 3-5 years of professional working experience as a Clinical Research Coordinator. + Working knowledge of GCP and FDA Regulations. + Proficiency in MS Word, Excel PowerPoint, or Suite. + Experience utilizing Electronic Data Capture (EDC) systems for clinical studies. **Desired:** + Desired Experience with digital medical device research studies. + Experience maintaining an Electronic Trial Master File (eTMF). **Education:** + BS/BA degree in life science, health science, RN, or related field **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (*********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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

Alljoined is a biotech research startup using EEG to decode human thought. We are seeking study participants in San Francisco. You will wear a non-invasive EEG cap while seated at a computer, view images and videos, and answer simple questions. The device measures brain responses and does not cause discomfort. Requirements Age 18-55 Comfortable sitting for extended periods Fluent in English Able to attend 5 total sessions No dreadlocks, braids, wigs, or hairstyles incompatible with an EEG headset Location Inner Richmond, San Francisco, CA Session Length Approximately 2.5 hours (budget for 3) Compensation $20 per hour

Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Clinical Research Specialist 5 months with a possibility to extend Medtronic - Santa Rosa, CA Duties: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Assist in preparation of study materials and/or training. Interface with, and assure training of investigators, site staff, and Medtronic clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review). May arrange conference calls, staff meetings and training events. Assist data management group with review of clinical data/information and oversight of data correction. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. Must be willing to assist with other duties as needed such as filing and document tracking. Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. Qualifications Top 3 qualifications: Previous clinical research experience Ability to prioritize and strong critical thinking skills Attention to detail and strong communication skills Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 619-727-5167 ASAP! I want to know more about your preferences. If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!

+ Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study + Ensures alignment of regional deliverables with overall study goals **Essential Functions of the job:** **Regional Leadership** + Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study + Leads external vendors involved in study delivery on a regional level + Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional study team members **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these + Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study plans as required + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems and tools is entered and up to date + Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports + Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region + Manages the trial data collection process for the region, drives data entry and query resolution + As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads + Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point in time throughout the study life cycle + Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented + Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate + Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies + Contributes to development, optimization and review of work instructions and SOPs as required **Budget and Resources** + Works with the sourcing team to select and manage regional study vendors + Manages regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides performance feedback on team members as required + Might mentor junior team members **Computer Skills:** MS Office, Project Planning Applications **Other Qualifications:** + 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead in clinicial functions + Experience as CRA is preferred **Travel:** Travel might be required as per business need **Education Required:** Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred _*exceptions might be made for candidates with relevant clinical operations experience_ **Competencies:** **Ethics -** Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures. **Planning/Organizing** **-** Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction. **Communication** **-** Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information. **Teamwork -** Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others. **Adaptability -** Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. **Technical Skills** **-** Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others. **Dependability** **-** Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. **Quality** **-** Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. **Analytical** **-** Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. **Problem Solving** **-** Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. **Project Management -** Communicates changes and progress; Completes projects on time and within budget. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

The Homeless Services Clinic Coordinator in Oakland, Ca is responsible for overseeing the admin needs of clinics offered within homeless services programs. The HSCC plans programs clinic schedules, manages supplies and inventory, assists clinic and program providers to facilitate patient care, conducts patient outreach, oversees admin of contingency management, facilitates referrals, troubleshoots insurance eligibility issues, and provides patient health education. LifeLong Medical Care is a multi-site, Federally Qualified Health Center (FQHC) with a rich history of providing innovative healthcare and social services to a wonderfully diverse patient community. Our patient-centered health home is a dynamic place to work, practice, and grow. We have over 15 primary care health centers and deliver integrated services including psychosocial, referrals, chronic disease management, dental, health education, home visits, and much, much more. Benefits Compensation: $21 - $23/hour. We offer excellent benefits including: medical, dental, vision (including dependent and domestic partner coverage), generous leave benefits including ten paid holidays, Flexible Spending Accounts, 403(b) retirement savings plan. Responsibilities Essential Functions * Conduct patient intakes, registers new patients, and maintains accurate medical records * Register new patients and scan necessary documents in the Electronic Health Record * Look up and enter insurance information into individual health records and trouble shoot eligibility issues * Maintain up to date patient demographic and insurance information in agency clinic management and health record systems * Maintain provider visit schedule of appointments and provide regular reminders to providers of their scheduled appointments * Work with on-duty staff to conduct regular outreach effort to patients to and ensure patients attend scheduled appointments on time * Manage patient flow during clinic hours, including check in and check out * Assure that clinics have necessary supplies, that clinic facilities are set up prior to scheduled clinic time, and exam rooms are stocked appropriately prior to patient appointments * Conduct regular inventory of clinic supplies, submit requisitions for supply orders, and assure out-of-date supplies are disposed of according to relevant agency guidelines * Coordinate site waste disposal with appropriate vendors * Maintain and record vaccine refrigerator and freezer temperature log * Label and organize supplies appropriately to make sure they are retrievable * Track patient encounters and enter charges for each completed encounter on a weekly basis * Enter and track encounter and billing data to ensure clinic is meeting productivity targets * Run insurance and check eligibility for every new patient, at patient intake, and once a month for all patients * Assist patients whose Medi-Cal is no longer active or registered in Alameda County to submit applications and recertifications to renew or establish insurance and benefits * Contact insurance providers or other funders to obtain authorizations to ensure reimbursement for services * Coordinate with case managers, providers, and referral specialists to facilitate referrals for labs, diagnostic tests, specialty care, and follow up appointments * Manage day-to-day operational aspects of contingency management and train staff on how to administer rewards * Work with site staff to conduct regular outreach efforts to clients * Participate in and help conduct group visits at each site * Attend all meetings that are required for this position, take notes, and distribute notes to meeting attendees Qualifications Qualifications * Commitment to the provision of primary care services for the underserved with demonstrated ability and sensitivity in working with a variety of people from low-income populations, with diverse educational, lifestyle, ethnic and cultural origins. * Strong organizational, administrative and problem-solving skills, and ability to be flexible and adaptive to change. * Ability to effectively present information to others, including other employees, community partners and vendors. * Ability to seek direction/approval on essential matters, yet work independently with little onsite supervision, using professional judgment and diplomacy. * Work in a team-oriented environment with a number of professionals with different work styles and support needs. * Excellent interpersonal, verbal, and written skills. * Conduct oneself in internal and external settings in a way that reflects positively on LifeLong Medical Care as an organization of professional, confident and sensitive staff. * Ability to see how one's work intersects with that of other departments of LifeLong Medical Care and that of other partner organizations. * Make appropriate use of knowledge/ expertise/ connections of other staff. * Be creative and mature with a "can do", proactive attitude and an ability to continuously "scan" the environment, identifying and taking advantage of opportunities for improvement.

Job DescriptionDescription: The Clinical Research Coordinator (CRC) is the primary point of contact for the study patient and sponsor representatives. The CRC works closely with the Principal Investigator and Sub-Investigator to ensure the safety and well-being of the study patient is protected. CRCs are expected to maintain all documents, processes, and supplies for all assigned duties according to protocol. Essential functions: Study recruiting activity, including pre-screening, screening, and recruitment of patients. Obtains informed consent per ICH/GCP and site SOPs. Interviews and collects data from study patients. Creates and completes source documentation and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintains a thorough understanding of all data collection instruments and collects data accurately and according to protocol. Performs basic data gathering, EDC transcription, and manipulation of source documents. Maintains regulatory binders (ISF) with applicable documents and communicates effectively with study monitors (CRAs) during site visits and audits. Coordinates study visits and performs procedures such as AE collection, ConMeds, and eye pressure assessment. Schedules subject visits as needed and obtains vitals (height, weight, pulse, respiratory rate, blood pressure, etc.) and ECGs. Dispenses and collects study medication and provides accurate Investigational Product (IP) accountability. Reports temperature excursions in a timely manner. Collects and processes laboratory specimens for study participants according to protocol. Other responsibilities: Duties assigned by the Clinical Research Supervisor/Manager or Director of Operations. Requirements: Skills Required: Computer literate and experience using EHR, MS Office suite, web browsing, email, and spreadsheets. Adaptable and able to learn quickly. Meticulous and detail oriented. Able to follow directions with minimal supervision. Excellent written and verbal communication skills. Excellent customer service skills. Takes initiative, able to see a task that needs to be completed and completes it. Must be able to multitask and able to handle a high volume of patients. Open to work a flexible work schedule. Experience preferred: 3-5 years as a clinical research coordinator. Additional past medical office experience. Preferred knowledge of the design ad conduct of clinical studies. Phlebotomy certification and experience preferred. Ophthalmology clinical research experience preferred. Education required or equivalent: Bachelor's degree preferred. Physical standards, including lifting and pushing requirements: Must be able to remain in a stationary position for 50% of scheduled shifts or more, be able to frequently move about the office to direct patients, access office supplies and equipment, and be able to lift up to 50 pounds. Must be able to communicate with patients to convey necessary medical and financial information and document accurately in EMR and practice management system. Travel requirements: Study-related travel, including travel to clinic locations as needed and sponsor-related travel (investigator meetings, training, etc.). Equipment: This position requires the use of telephone and office equipment such as computers, copier, fax machine, and scanner. Requires use of Microsoft Office products and occasional use of medical equipment such as exam chairs, imaging equipment, pharmaceutical refrigerators, and diagnostic testing equipment. Unique conditions of the position: OSHA Classification Category I. Job duties include exposure to blood, bodily fluids, or tissues. 2-year commitment preferred.

Irvine Clinical Research is the largest independent memory research center on the West Coast. Alzheimer's Disease is a serious cognitive illness that affects millions of people each year. Every research trial brings us closer to finding a treatment or cure for Alzheimer's Disease. A recent study conducted at Irvine Clinical Research was successful in slowing cognitive decline by as much as 27%. Irvine Clinical Research is looking for a friendly, outgoing person to join our team as a Clinical Research Recruitment Coordinator. You will be speaking with potential study participants about their health concerns, especially around memory loss, and when appropriate, presenting research as a care option.In this role, expect to Recruit study participants via short telephone interviews; make outbound phone calls to achieve appointment scheduling goal Build rapport with potential participants to ensure engagement and retention Promote Irvine Clinical Research's services and the opportunity to advance the fight against Alzheimer's Disease via study participation Work independently while still being accountable to recruitment goals Input data into electronic systems in a consistently timely and accurate manner Assist with other recruitment, marketing, and outreach efforts as needed To succeed in this role, you have A welcoming, friendly, and professional attitude and demeanor that you bring with you every day Ability to consistently build trust and rapport with persons concerned about memory High attention to detail for all of your work responsibilities Time management skills to coordinate and manage recruitment calls efficiently Nice to have, but not essential Experience speaking with people with cognitive issues or older adults Call center or clinical research experience Salesforce/CRM/CTMS experience Equal Employment OpportunityIrvine Clinical Research is committed to diversity within our organization and building an equitable and inclusive environment for people of all backgrounds and experiences. Irvine Clinical Research provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Irvine Clinical Research complies with all state and local laws governing nondiscrimination in employment in any location. We especially encourage members of traditionally underrepresented communities to apply, including women, people of color, LGBTQ people, veterans, and people with disabilities.

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

Irvine Clinical Research, a research site specializing in clinical trials of Alzheimer's Disease, is seeking applicants for a Clinical Research Coordinator I. The CRC will work under close supervision of our doctors and a research manager as a coordinator on Phase II/III clinical trials in Neurology and Psychiatry.Job Duties Coordinate the day-to-day clinical operations of a clinical research study Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Recruit, prescreen, and screen potential study participants Conduct diagnostic, efficacy, and safety assessments as needed Job Requirements Interest in working with persons with neurological or psychiatric indications such as Mild Cognitive Impairment, Early Alzheimer's Disease, or Depression Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with computerized systems A command of professional spoken and written English Bachelor's degree or higher Hours and CompensationThis is a full-time employment position based in-person at our clinic in the Alzheimer's Orange County building in Irvine. The starting salary for this position is $25 per hour (approximately $52k per year). Higher salary is negotiable with candidates who possess relevant degrees in addition to their bachelor's degree. The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year.