Clinical Trial Project Manager
Clinical Research Coordinator Job In Sacramento, CA
Clinical Trial Project Manager
Contract: 6 months-1 year, M-F (40 hours/week)
Responsibilities:
Oversee the execution of 5-6 clinical studies in their final or follow-up phases, while providing support for newer studies.
Manage trial preparation, including organizing supplies, equipment, and investigator training.
Lead and mentor staff to address challenges, ensuring minimal oversight is required.
Operate effectively in limited space while managing high supply volumes.
Ensure strict compliance with HIPAA, FDA regulations, GCP, and other regulatory requirements.
Monitor and support studies in the dermatology, stroke, and cardiology therapeutic areas.
Coordinate site visits, spending 80% of time at the Sacramento Morse St. location and 20% at the South Sacramento site.
Requirements:
Bachelor's degree in a related field.
Proven clinical trial experience, particularly in operational roles.
Strong knowledge of GCP, HIPAA, compliance requirements, and regulatory audits.
Familiarity with EDC systems like Epic or RedCap.
Experience managing high-intensity teams and complex projects.
Ideal candidates have backgrounds from Stanford, UCSF, or UC Davis, with a proven understanding of clinical trial processes.
Preferred Skills and Experience:
Demonstrated experience in risk-based monitoring and implementing CAPAs.
Knowledge of regulatory audits, IRB, and SOPs.
Strong conflict resolution and task prioritization skills.
Clinical Research Associate
Clinical Research Coordinator Job In Sacramento, CA
Job Title: Clinical Research Associate
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary:
In this contract CRA role, you will be responsible for monitoring the progress of clinical studies (primarily, our phase 3 Precision-T study), either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. You can be based anywhere in the U.S., although west coast is preferred. Travel expected: :1+ site visit per week, for sites that do not permit virtual monitoring.
Responsibilities:
Conduct interim monitoring visits (IMVs) and ISF review
Review electronic medical records (EMR)/patient data
Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
Provide support to site staff including research coordinators and physicians
Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
Desired Qualifications:
BA/BS or equivalent with a minimum of 3+ years of relevant clinical trial management experience
Therapeutic experience in oncology/hematology and cell and gene therapy preferred
Prior CRA experience working directly for sponsor, ideally a start-up/or small company, in a co-monitoring capacity
Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
Experience with Trial Master File management according to the DIA reference model
Experience operating within various site EMR/EHR systems
Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals
Personal Qualities:
Highly detail oriented with special attention to quality and quality control
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Well organized and able to work under tight deadlines
Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills, including verbal and written communication, are essential
Ability to work in a collegial and collaborative manner; independently and as part of a team
Ability to work in a fast-paced and informal startup environment
Highly tolerant and respectful of all members of our team
Strong problem-solving skills with desire to improve upon established processes
Sense of humor
Who We Are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
To learn more: **********************************
**all official communication will be *****************; please beware of scams**
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
**********************/jobs/view/d04107404e4ad06601d**********65f
Clinical Research Associate II
Clinical Research Coordinator Job In Sacramento, CA
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Manager, GCP Excellence in Clinical Trials
Clinical Research Coordinator Job In Sacramento, CA
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, GCP Excellence in Clinical Trials based remotely reporting to the Associate Director, GCP Excellence in Clinical Trials.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
**_GOALS:_**
+ Manage and facilitate cross-functional study execution teams' efforts towards proactive GCP inspection readiness, focusing on process adherence, TMF documentation, inspection preparation and inspection execution activities, including collaboration with CRO partners.
+ Work in alignment with Clinical Quality Assurance (CQA) and Global Development Compliance partners to assure approach to inspection readiness strategy is actioned to study execution teams
+ Support the implementation of inspection readiness process improvements and assist with change management for clinical trial delivery projects and initiatives.
+ Coordinate TMF inspection readiness and oversight strategies with study execution teams in alignment with GCP Excellence in Clinical Trials leadership.
**_A_** **_CCOUNTABILITIES:_**
+ Provide support in project management, oversight, and expert GCP guidance to study execution teams in Inspection Readiness including, but not limited to, Inspection Readiness Plans, completion of Inspection Readiness Checklist, TMF quality and process adherence, identification & mitigation of inspection risks, storyboard development for high-risk issues, and creation of functional presentations in preparation for mock and actual inspection.
+ Assist study execution teams in prioritizing process adherence, inspection readiness deliverables and mitigation of inspection risks in real time throughout the study lifecycle.
+ Guide study teams on adherence to ways of working and well-maintained study documentation and action compliance monitoring signals with study execution teams.
+ Report to senior leadership on key performance indicators related to clinical trial inspection readiness and TMF documentation quality.
+ Coordinate with appropriate Sponsor and CRO subject matter experts in inspection readiness activities and actively lead/participate in Strategy Team Meetings Core Team Meetings for assigned Inspection Readiness projects.
+ Maintain documentation such as project management plans/trackers, timelines, and progress reports to track, manage, and report on study execution teams' inspection readiness.
+ During inspections, assist in management of functional teams by facilitating request strategies and responses with appropriate functional SMEs; providing necessary follow-up and guidance to ensure timely fulfillment; liaising with functional SMEs and QA to assure alignment; providing regular status updates to appropriate stakeholders and leadership.
+ Contribute to departmental objectives, representing GCP Excellence globally, assisting in implementing GCP Excellence processes to enhance support and compliance.
+ Act as subject matter expert for operating model and TMF processes, supporting study-execution teams in development of risk-based TMF oversight strategies. Monitor compliance of TMF deliverables and oversight of resources in the execution of inspection readiness plans.
+ May manage day to day activities of assigned staff providing guidance, coaching and supporting issue escalation to achieve organizational and individual development goals.
**_EDUCATION AND EXPERIENCE:_**
+ Bachelor's degree preferred or commensurate with experience.
+ 5 or more years clinical research experience in pharmaceutical or biotechnology field required.
+ Knowledge of and experience in regulatory inspection readiness and execution processes.
+ Experience with Sponsors, CROs and outsourced clinical trial activities.
+ Solid knowledge of drug development and clinical trial processes, including related standards and documents.
+ Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required.
+ Solid knowledge of regulatory requirements governing clinical trials and industry best practices.
+ Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Massachusetts - Virtual
**U.S. Base Salary Range:**
$108,500.00 - $170,500.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Massachusetts - Virtual
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
\#LI-Remote
Clinical Research Coordinator II
Clinical Research Coordinator Job In Sacramento, CA
We are so glad you are interested in joining Sutter Health! Organization: SHSO-Sutter Health System Office-Bay Collects, compiles and presents clinical data for assigned area, ensuring accuracy, timeliness and accessibility of information. Maintains clinical and/or research databases for identified programs/ specialty clinics. Collects data used for multiple purposes, which may include process improvement activities and clinical effectiveness/research studies. May prepare information for patient/family education and/ or participate in community outreach activities.
Job Description:
EDUCATION
Bachelor's: Science or health-related field or equivalent education/experience
PREFERRED EXPERIENCE AS TYPICALLY ACQUIRED IN
2 years of experience conducting clinical research.
2 years of experience in retrospective data collection, patient interviewing and interacting with a variety of patient populations in a variety of patient settings.
2 years of experience ensuring compliance with research regulations.
SKILLS AND KNOWLEDGE
Knowledge of Federal and State regulations and International Guidelines related to Good Clinical Practices in clinical research.
Ability to interpret a variety of data and instructions, furnished in written, oral, diagram, or schedule form.
Possess written and verbal communications skills to communicate with fellow team members, supervisors, patients, and other hospital personnel.
Well-developed time management and organizational skills, including the ability to prioritize assignments and work within standardized policies and procedures to achieve objectives and meet deadlines.
Knowledge of computer applications, such as Microsoft Office Suite (Word, Excel, Access, and PowerPoint).
Ability to prioritize assignments and work within standardized policies and procedures to achieve objectives and meet deadlines.
Job Shift:
Days
Schedule:
Full Time
Shift Hours:
8
Days of the Week:
Friday, Monday, Thursday, Tuesday, Wednesday
Weekend Requirements:
As Needed
Benefits:
Yes
Unions:
No
Position Status:
Non-Exempt
Weekly Hours:
40
Employee Status:
Regular
Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans.
Pay Range is $42.08 to $63.13 / hour
The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate's experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package.
Senior Clinical Project Manager, Oncology
Clinical Research Coordinator Job In Sacramento, CA
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
**Job Overview**
Responsible for the planning, implementation, execution and management of multiple clinical studies and/or global studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations (CRO) if applicable.
**Job Duties and Responsibilities**
+ Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
+ Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
+ Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
+ Provides oversight and management of CROs, consultants and vendors.
+ Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
+ Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
+ Monitors the status of clinical data collection of assigned clinical trials.
+ Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
+ Prepares and reviews study-related documents when required.
+ Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
+ Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
+ Participates in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors' workshops and CRO Training.
+ Reviews correspondences and monitoring reports relating to the studies.
+ Prepare and deliver program/study updates.
+ Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
+ Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
+ Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
+ Provides input into contracts, work orders and/or change orders.
+ Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
+ Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
+ Ensures assigned studies adhere to all applicable regulations and requirements.
+ Provides input as the subject matter expert for the assigned studies during regulatory inspections.
+ Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
+ Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
+ Evaluate CRO and vendor performance and support the improvement initiatives.
+ Participate in the preparation, review, updating and training of SOPs.
+ Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
+ May Mentor other team members.
+ Perform other duties as requested by the senior management.
**Key Core Competencies**
+ Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
+ Demonstrated skills working within a matrix environment.
+ Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan.
+ Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
+ Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
+ Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
+ Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
+ Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
+ Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
+ Strong analytical skills with a data driven approach to planning, executing, and problem solving
+ Working knowledge of current global regulatory requirements and guidelines for clinical trials.
**Education and Experience**
+ Bachelor's degree in a related field required.
+ M.S./Ph.D. in a related life science discipline is preferred.
+ Thorough understanding of the oncology arena.
+ Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
The base salary range for this role is $137,100 to $171,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer**
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (******************************************************************
EEO is the Law Poster Supplement
Pay Transparency (***********************************************************************************************
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Clinical Trials Manager, Clinical Operations- Oncology
Clinical Research Coordinator Job In Sacramento, CA
**For Current Gilead Employees and Contractors:** Please log onto your Internal Career Site (****************************************************************************************************************************** to apply for this job. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**_CLINICAL OPERATIONS_** _: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products._
_Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead's operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need._
**Clinical Trials Manager, Clinical Operations - Oncology (CTM)**
**We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team.**
**Specific Responsibilities and Skills for Position:**
+ Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
+ Must be able to understand, interpret and explain protocol requirements to others
+ Maintains study timelines
+ Coordinates review of data listings and preparation of interim/final clinical study reports
+ Assists in determining the activities to support a project's priorities within functional area
+ Contributes to development of RFPs and participates in selection of CROs/vendors
+ May be asked to train CROs, vendors, investigators and study coordinators on study requirements
+ Contributes to development of study budget
+ May serve as a resource for others within the company for clinical trials management expertise
+ Able to examine functional issues from an organizational perspective
+ May contribute to development of abstracts, presentations and manuscripts
+ Under supervision, may design scientific communications within the company
+ Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
+ Must have a general, functional expertise to support SOP development and implementation
+ Travel may be required
**Knowledge:**
+ Excellent teamwork, communication, decision-making and organizational skills are required
+ Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
+ Working knowledge and experience with Word, PowerPoint and Excel
**Experience and Skills:**
+ At least 5+ years of experience and BS/BA in a relevant scientific discipline
+ At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
+ Prior oncology clinical trials experience
The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (***********************************************************************************************
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please log onto your Internal Career Site (****************************************************************************************************************************** to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Clinical Research Coordinator - Oncology
Clinical Research Coordinator Job 10 miles from Sacramento
As one of the nation's largest nonprofit systems, CommonSpirit Health now has more than 2,200 care sites and 140 hospitals in 24 states. We serve some of the most diverse communities across the nation, and in each location, humankindness leads the way.
The CommonSpirit Health Research Institute offers comprehensive clinical research services and support for various research activities. Their primary focus includes multi-site clinical trials, local and large-scale data research, partnerships with industry and academia for technology and innovation research, physician-initiated research, resident-initiated research in teaching facilities, nurse-initiated research, and health sciences student-initiated research. The institute aims to provide start-to-finish research services and assist in advancing medical knowledge and patient care.
CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources CommonSpirit is committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside our hospitals and out in the community.
**Responsibilities**
The Clinical Research Associate (CRA) works with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM) to support the planning, implementation and coordination of clinical trials and other research projects managed by the CommonSpirit Health Research Institute. Duties may vary depending on the size and complexity to each study. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent assists with clinical trial or other research project coordination duties as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as CommonSpirit Health policy.
+ Coordinate and participate in site initiation and other sponsor-required training for all protocols.
+ Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
+ Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
+ Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
+ Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
+ Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
+ Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
+ With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols.
+ Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy.
+ Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or CommonSpirit Health.
+ To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
+ Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
+ Attend investigator/coordinator meetings as required by study sponsors.
+ Serve as liaison between participants, physician investigators, sponsors of research, IRBs, CSHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
+ Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
\#LI-CSH
**Qualifications**
+ Minimum 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials.
+ Minimum 3 years of experience interacting with patients in a healthcare setting required.
+ Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
+ Current certificate of Human Subjects Protection and Good Clinical Practice training required.
+ Bachelor's degree in a science or health-related field or a combination of education and/or additional job-related experience in lieu of the degree, required.
+ Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
+ Experience in implementation of research protocols and clinical trials processes required.
+ Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
+ Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
+ Lab processing experience required, Phlebotomy certification preferred.
**Pay Range**
$34.50 - $42.28 /hour
We are an equal opportunity/affirmative action employer.
Bilingual Clinical Research Coordinator 182825
Clinical Research Coordinator Job In Sacramento, CA
In this role you will ensure IRB approved protocols are implemented and followed; execute the
informed consent process and monitor patient status and safety; collect and organize research
data; schedule and conduct study-specific training and site in-services to study related staff on
new or amended protocols, and educate patients and their families about treatments and
possible side effects. The Clinical Research Coordinator must also be able to perform clinical
tasks.
Responsibilities:
● Site preparation.
● Obtaining informed consent, patient screening and recruitment.
● Patient enrollment, and conducting study visits.
● Maintaining and dispensing study product and supplies.
● Completing and ensuring the quality of case report forms.
● Maintaining source documents
● Ensuring site quality.
● Maintain a thorough and meticulous working knowledge of protocol schemas and
● requirements.
● Collaborate with physicians to maintain strict protocol adherence and serve as a
● resource for members of staff.
● Writes patient information sheet for clinical studies for submission to IRB, as well as
● complete the necessary documents for IRB admission in a timely fashion.
● Participate in the development and implementation of patient educational materials.
● Writes patient information sheet (ICF) for clinical studies for admission to IRB, as well as
● complete the necessary documents for IRB submission in a timely fashion.
● Review research and administrative documents to determine action items, prioritizing
● and tracking action items.
● Responsible for completion, submission and tracking of regulatory documents to the
● IRB.
Clinical Research Coordinator
Clinical Research Coordinator Job In Sacramento, CA
We are seeking a dedicated Clinical Research Coordinator to join our dynamic team. This role involves patient-facing duties, including screening, recruitment, and managing source documentation. You will document in EMR, order labs, and manage patient appointments. You will be responsible for screening, consenting, and enrolling patients on oncology trials and following them through the course of their therapy.
Responsibilities
* Screen, consent, and enroll patients in oncology trials.
* Manage patient visits and ensure questionnaires and research procedures are completed.
* Work with clinic staff to schedule appointments, such as EKGs or vitals.
* Ensure protocol compliance and timely completion of tasks.
* Interact with nursing staff and medical assistants.
* Collaborate with clinical staff for insurance authorizations and scheduling.
* Work closely with infusion nurses to arrange appointments.
* Assist patients with understanding their calendar of events and participation requirements.
Essential Skills
* Experience in patient study enrollment and managing study requirements.
* Ability to read protocols, notice side effects, and assist patients.
* Bachelor's degree in a relevant field.
* Proficiency in clinical research, patient pre-screening, oncology, and chart review.
* Strong organizational skills and attention to detail.
Additional Skills & Qualifications
* ACRC Exam/Certification reimbursement.
* ACRP membership fees covered and potential conference attendance.
* Tuition reimbursement programs available.
* Experience in dealing with oncology patients and understanding their needs.
Work Environment
The work involves various types of trials, including pharmaceutical-sponsored Phase I and II, some Phase III, investigator-led protocols, and trials funded by national clinical trial groups. The clinical group is divided into disease teams and works closely with data management staff. The position requires being on-site daily for office visits, with a typical schedule of Monday to Friday, 8 AM to 5 PM, with some flexibility based on the clinic schedule. Working in the Comprehensive Cancer Center offers a prestigious opportunity to be at the cutting edge of oncology research.
Pay and Benefits
The pay range for this position is $30.00 - $40.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Sacramento,CA.
Application Deadline
This position is anticipated to close on Feb 14, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Senior Clinical Research Associate
Clinical Research Coordinator Job 26 miles from Sacramento
Cutera, Inc. is a leading aesthetics device company with a comprehensive product portfolio and a worldwide distribution footprint. The Company's technology enables physicians to provide sophisticated solutions for a wide range of medical aesthetic applications. We are looking for a key member to join our fast-paced R&D engineering team in changing the landscape of medical aesthetics.
Please visit ************** for more information about us!
Job Description
Position Summary:
We are seeking a Senior Clinical Research Associate to join our clinical team in its mission to improve lives through medical aesthetic technologies driven by science. Our products use a broad range of innovative laser and radio frequency technologies designed by our scientists and engineers to enable first-to-market applications and best-in-class products for dermatology.
Reporting to the Director of Clinical Research, the Senior CRA is responsible for leading and coordinating activities among participating study physicians and maintaining study records. Serving as the primary point of contact for study sites, this role oversees the organization and execution of pre- and post-market clinical research studies. The Senior CRA collaborates with research staff to uphold best practices, ensuring study integrity and accurate data documentation. Additionally, you will establish and maintain relationships with investigators, site coordinators, and regulatory personnel, ensuring compliance with GCP guidelines and all relevant clinical study regulations.
Duties & Responsibilities:
* Lead the development, production and compilation of study documents such as protocol, case report forms (paper or electronic), informed consent, subject questionnaire, clinical study reports, clinical portions of applicable regulatory submissions, IRB submission, data management or statistical analysis plans or other controlled documentation.
* Perform site qualification, study initiation, site training, interim monitoring and study close-out visits, and complete timely and accurate site visit reports.
* Design forms (electronic or paper based) for receiving, processing, or tracking data.
* Develop and maintain study and data tracking tools and report study/ data metrics to supervisory staff.
* Track and ensure the timely flow of study documentation and case report forms, including in-house data flow and/or electronic forms transfer.
* Monitor data -- remotely, on site, and via other approved modes - with a focus on data integrity (completeness, accuracy, consistency, timeliness) and patient safety.
* Create and manage clinical databases and process clinical data, including receipt, entry, verification, or filing of information.
* Prepare data analysis listings and activity, performance, or progress reports.
* Generate data queries and liaise with the study sites to resolve identified problems in a timely manner.
* Prepare and maintain the study essential documents including sponsor and site-specific regulatory documentation (binders or eTMF)
* Write work instruction manuals, data capture guidelines, and other study specific standard operating procedures.
* Consistently assess processes, systems, and technologies for efficiency and compliance with procedures; suggest revision to increase productivity as applicable.
* Analyze clinical data using appropriate statistical tools
* Help record and track clinical trial data on online government databases. (***********************
* Help select specific software programs for various research procedures and scenarios as needed.
* Train staff on study procedures, photography and software program usage.
* Provide support and information to functional areas such as clinical affairs, regulatory, research & development and marketing.
* Ensure study documentation, procedures, data collection and analysis are conducted in accordance with Cutera SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.
* Other duties as assigned.
Qualifications
Minimum Requirements & Qualifications:
* B.Sc. in the life sciences or allied health/medical related field, or equivalent experience.
* 3+ years of experience in a clinical research environment preferred.
* Experience independently running a study from start-up through close-out required.
* Experience in the medical device and/or dermatology or aesthetic space preferred.
* Knowledge of GCP guidelines, medical terminology and clinical trial processes required.
* Proficient in the use of Microsoft Office Applications (Word, Excel, PowerPoint, etc.)
* Working knowledge of EDC, eTMF and/or other clinical research or data management software preferred.
* Experience participating in FDA bioresearch monitoring (BIMO) audits preferred.
* Strong interpersonal and organizational skills.
* Excellent oral and written communication skills.
* Strong organizational skills with attention to details.
* Self-motivated, flexible, and independent thinker.
* Ability to work in a fast-paced/demanding environment.
* Problem solver, ability to prioritize and/or multi-task
* Collaborative team member
* Must be willing to work on-site at corporate headquarters in Brisbane, CA (Monday through Friday).
* Travel up to 30 percent of the time.
Additional Information
Compensation:
Cutera expects to reasonably pay in the range listed below for this position based on the city and state listed in the job posting. The actual compensation is influenced by a wide array of factors, including but not limited to skill set, level of experience, education, and candidate residence if the position is remote or field-based.
Base salary range: $110,000 - $130,000
All your information will be kept confidential according to EEO guidelines.
If you are ready to become part of our spectacular, growing, and FUN company, then apply today!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.
Travel Per Diem Mobile Research Nurse- Pediatric Preferred
Clinical Research Coordinator Job In Sacramento, CA
Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37's extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.
The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures.
*This is a travel role that requires on-site visits to participants homes.
Duties for this position include but are not limited to:
Participate and provide research nurse services to qualified study participants at home
Apply clinical research and nursing practices to develop solutions to complex problems
Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
Participate in activities that will further the operational development of Science 37 nursing service delivery
Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
Other duties as assigned as the needs of Science 37 evolve and change
This position has the following qualifications:
BSN degree preferred
Full Vaccination Required subject to applicable law: All Science 37 personnel who interact in person with trial participants must be fully
vaccinated against COVID-19.“Fully vaccinated” means having received both doses of the Pfizer or Moderna vaccines or the single-dose Johnson & Johnson vaccine.
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Travel and availability qualifications are as follows:
1-2 days minimum a week dedicated to support Science 37's study visits
Weekday/night availability required
Must be willing to travel to a participants homes
Active Driver's License
Science 37 is looking for people with the following skills and competencies:
BSN degree preferred
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Active Driver's License
Weekday/night availability required
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
Ability to obtain nursing license in multiple states based on study needs
Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
Access to a reliable vehicle to perform study participant visits and transport equipment
Ability to drive to local and/or remote locations to perform study participant visits
Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
Ability to communicate in English (both verbal and written)
There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.
Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate's actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.
Science 37 is an equal opportunity employer.
We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!
To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here
Clinical Coordinator
Clinical Research Coordinator Job 45 miles from Sacramento
1150 E Leland Rd, Pittsburg, California, 94565, United States of AmericaDaVita is Hiring!We are looking for a Clinical Coordinator to join our amazing team! If you are looking to give life in an outpatient dialysis center considering DaVita. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way, consider DaVita and apply today!Some details about this position:
At least 6 months dialysis experience is required.
Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being.
Training may take place in a facility or a training clinic other than your assigned home clinic
Potential to float to various clinics during and after your training
You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays
What you can Expect:
Build meaningful and long term relationships with patients and their family in an intimate outpatient setting.
Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians.
Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge.
Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up.
You will work with your head, heart and hands each day in a fast paced environment.
What We'll Provide: We offer competitive compensation plus an amazing benefit packages: • Medical, Dental & Vision• 401K (matching) • Retirement Plans • Hospital Care Plan • Paid Training • PTO and Paid Holidays • PTO cash out • Health Saving Account• Flexible Spending Account • Professional Growth Opportunities • Tuition Reimbursement• Employee Stock Purchase Options• Critical Care Insurance• Life & Disability InsuranceRequirements:
Current Registered Nurse (RN) license in the state of practice
Current CPR certification required
At least 18 months of registered nursing experience
Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required
Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred
Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred
Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree
Current CPR certification required
Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system
Supervisory experience preferred; willingness, desire, and ability to supervise required
Basic computer skills and proficiency in MS Word and Outlook required
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
Applications are accepted on an ongoing basis.
#LI-NL1
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
Applications are accepted on an ongoing basis.
Salary/ Wage Range
$52.00 - $68.00 / hour
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Clinical Coordinator
Clinical Research Coordinator Job 45 miles from Sacramento
1150 E Leland Rd, Pittsburg, California, 94565, United States of America DaVita is Hiring! We are looking for a Clinical Coordinator to join our amazing team! If you are looking to give life in an outpatient dialysis center considering DaVita. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way, consider DaVita and apply today!
Some details about this position:
* At least 6 months dialysis experience is required.
* Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being.
* Training may take place in a facility or a training clinic other than your assigned home clinic
* Potential to float to various clinics during and after your training
* You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays
What you can Expect:
* Build meaningful and long term relationships with patients and their family in an intimate outpatient setting.
* Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians.
* Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge.
* Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up.
* You will work with your head, heart and hands each day in a fast paced environment.
What We'll Provide:
We offer competitive compensation plus an amazing benefit packages:
* Medical, Dental & Vision
* 401K (matching)
* Retirement Plans
* Hospital Care Plan
* Paid Training
* PTO and Paid Holidays
* PTO cash out
* Health Saving Account
* Flexible Spending Account
* Professional Growth Opportunities
* Tuition Reimbursement
* Employee Stock Purchase Options
* Critical Care Insurance
* Life & Disability Insurance
Requirements:
* Current Registered Nurse (RN) license in the state of practice
* Current CPR certification required
* At least 18 months of registered nursing experience
* Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required
* Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred
* Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred
* Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree
* Current CPR certification required
* Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system
* Supervisory experience preferred; willingness, desire, and ability to supervise required
* Basic computer skills and proficiency in MS Word and Outlook required
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
Applications are accepted on an ongoing basis.
#LI-NL1
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
Applications are accepted on an ongoing basis.
Salary/ Wage Range
$52.00 - $68.00 / hour
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Clinical Coordinator (INTERNAL APPLICANTS ONLY)
Clinical Research Coordinator Job 43 miles from Sacramento
Who is Rendevor Dialysis?
We are a family-owned and operated company founded over 30 years ago by a Dialysis RN who believes everyone is entitled to excellent medical treatment from talented clinicians.
Our Mission
To bring thriving onsite dialysis partnerships to any under-serviced healthcare institution in need.
What s In It For You?
Our company offers a competitive total rewards package above industry standards in most markets and we pride ourselves in providing a caring, positive culture for our employees.
We offer an extremely generous package including:
Hourly Rate: $57.00 - $67.00/Per Hour (Based on Documented Experience, Qualifications and Market Data)
Fantastic employee benefit package
Employer contribution to H.S.A.
F.S.A. tax savings benefits
A 4% dollar-for-dollar company match to the 401k plan with immediate vesting
A generous PTO accrual program
A PTO cash-out provision
Tuition reimbursement program
Employee referral bonus program
Robust employee recognition and appreciation program
Quality employee training and development programs
Several holidays paid at time and a half
Annual holiday gift bags for all employees
Comprehensive Medical Benefits
Vision
Dental
STD/LTD/Voluntary Life
Accident, Critical Illness and Hospital Indemnity Plans
Pet Insurance
Discounted auto and home insurance
Discounted legal services program
Employer-paid life insurance for 1x employee salary
Employer-paid assistance program with complimentary counseling, wellness, and legal sessions for employees and household members
Complimentary year-long weight loss program
Health & Wellness Program with gift card giveaways
What You ll Do:
The Clinical Coordinator (CC) is responsible for all overall operations and activities of the smaller-sized dialysis units operated by Rendevor Dialysis. Through effective leadership, professionalism, and management, the Clinical Coordinator uses clinical/nursing knowledge and dialysis experience to ensure quality measures are met by delivering safe dialysis treatments.
The Clinical Coordinator develops, trains, coaches, acts as a resource and oversees clinical teammates assigned to the unit as well ass coordinates activities with the technical personnel.
The Clinical Coordinator provides excellent customer service and maintains strong relationships through effective communication and visibility with providers, DOC/BOP, Managed Healthcare Organization, Post Acute, Hospitals, etc.
As required by the Regional Director, the Clinical Coordinator is responsible for financial management such as inventory/supplies, accurate staffing efficiencies and ensuring compliance with applicable company and state regulatory requirements.
Reports to the Regional Director as assigned.
This dialysis unit is in:
Stockton, CA within California Health Care Facility
As in any setting, this involves teamwork and coordinating care with the healthcare team. In addition to the healthcare team, you are also required to maintain strong relationships, regular communication, and visibility with clients (site Managed Healthcare, DOC/BOP, etc.)
Minimum Qualifications
Education and Experience
Graduation from an Accredited Nursing School or Equivalent
Current RN License for California & current CPR certification (or within three months of hire)
One year of Hemodialysis RN experience is required
Previous management experience preferred
Required Skills and Competencies
Ability to read, write, speak, understand and satisfactorily communicate in English.
Strong technical/computer proficiency with laptops, tablets, Outlook, Excel, PowerPoint, Word, SharePoint, etc.
Ability to quickly learn a variety of technical systems and equipment
Essential Duties and Responsibilities:
Leadership
In conjunction with Regional Director, ensures that dialysis unit operates in compliance with all HIPAA, OSHA, ESRD, state and federal regulations, as well as company policies and procedures.
Leads, coaches, and guides other clinical teammates, depending on unit size.
May be required to monitor clinical teammate in-servicing and skills checks.
Delegates tasks as necessary to maximize time and efficiency.
Holds team huddles to discuss unit goals and objectives and delivers pertinent corporate communication.
Ensures company policies and procedures are maintained for continuity across the company.
Utilizes a variety of systems (MPulse, EMR, ADP, HCP, Equipment, etc.) and ensures compliance of the team.
Participates in onboarding, training, and educating new hires.
Ensures teammates have been properly in-serviced and checked off on skills.
Staffing
Manages staff scheduling and assignments to maintain appropriate patient to staffing ratios. This includes approving and/or denying PTO requests, sending teammates home for low patient census, managing overtime, etc.
Maintains contact with PRN bench staff, coordinating requirements for needed schedules
Facilitates staff development, training, and monthly education.
Is responsible to ensure all clinical teammates maintain license and/or certifications, and do not operate in unit if lapsed.
Participates in employee appreciation events and planning, based on provided budget from Regional Director.
In coordination with Regional Director, may need to be involved with teammate corrective action plans and annual evaluations of teammates.
Communicates staffing needs with RD and Talent Partner.
Depending on unit size, may be required to participate in interviews and candidate selection.
Encourages employee referrals and may be asked to contact referrals provided by staff.
Clinical
Delivers safe and effective patient care of all treatment modalities
Models thorough and accurate documentation in accordance with industry/client requirements and regulations and holds teammates to same high standards.
Actively participates in patient education, and ensures teammates follow same protocols.
Takes ownership of lab collections and documentation.
Applies critical thinking and time management skills.
Utilizes resources to develop and improve skills, and to monitor quality control measures ensuring continuous quality of patient care.
Depending on unit size and requirements, may be involved with patient care review meetings.
Completion of monthly facility audits (using an audit template provided by the RD). Develops action plans to address any deficiencies.
Acts as on-site liaison to the corporate biomedical team and timely notifies biomedical technician via MPulse of any service request.
Takes ownership of unit safety, cleanliness, and infection control
As appropriate, lobbies with client administration to eliminate any restrictions that may negatively impact patient outcomes, such as infection rate, catheter utilization, AMA rate, refusal rate, etc.
Monitors and assures that the patients receive adequate medical attention while in the dialysis unit.
Maintains the integrity of all protected health information.
Knows and follows policies and procedures of the DOC and Rendevor Dialysis, and monitors staff compliance of same.
Supervises medical records to ensure complete documentation.
Engages in constant learning and research of dialysis practices.
Continuous Quality Improvement/Quality Assurance & Performance Improvemen
Collaborates with the Clinical Services team to meet CQI/QAPI initiatives, clinical goals, and patient outcomes as needed.
Assists or may be responsible for the monthly completion of the Rendevor Application requirements.
Ensures adequate resources for supporting the CQI/QAPI process as applicable.
Communication (internal and external)
Maintains open communication with facility personnel, Managed Care group, providers, Rendevor management team, biomedical team, staff, etc.
May be required to attend and participate in facility meetings.
Checks email daily and responds appropriately and timely; uses company-provided email for all work-related email communications.
Maintains an open-door policy to communicate with teammates.
Maintains professionalism and privacy of confident information.
Payroll
Records both arrival and departure time via ADP s time and attendance system, following the guidelines outlined by Human Resources.
Assists new hires in accessing the time system and demonstrates proper log in/out procedures.
If assigned, approves timesheets of unit teammates in ADP.
Accounting
Timely and accurate review and submission of treatment rosters within two days of month end.
Inventory/Supplies
Accurate and timely submission of unit supply orders to the RAA and RD per the unit schedule.
Responsible for ensuring the unit has adequate supply inventories on hand, that no supplies are expired, and that emergency supply levels are understood/on-hand.
Communicates and coordinates a-typical supply ordering with RD/RAA and purchasing department.
Business Development
Works diligently to be a great on-site partner to our client and be a company advocate to all outside parties.
Actively listens for new opportunities within dialysis industry and sends any potential leads to supervisor.
General
Promotes and implements the Company s mission, vision, and core values.
Displays excellent and professional written/verbal communication skills.
Always maintains a professional demeanor; keeps an open door policy.
Operates with a high level of responsiveness in providing information and deliverables to supervisors.
Demonstrates a high degree of self-motivation and willingness to improve.
Openly receives and promptly acts upon any feedback from supervisors, peers, clients.
Volunteers to assist colleagues when necessary and assist with various projects as assigned.
Reports any incidents to Regional Director.
Reports work-related injuries to carrier via web portal. Follows up with HR and RD. Collects statement from claimant as well as witness statements.
Must maintain RN license, CPR and a clean background.
Checks company email each working day and responds timely and appropriately; uses company-provided email for all work-related email communications.
Adheres to all company and departmental policies and procedures.
Maintains regular and predictable attendance and punctuality.
Other duties as assigned.
Supervision:
This position will report to the Regional Director.
This position will supervise clinical team members.
Background Check:
The California Department of Corrections/Federal Bureau of Prisons and all applicable law require a comprehensive background check for all employees working in this position. This background check will be conducted after an offer, if any, is made.
Work Environment:
This role exists in a hospital, training center, patient residence, or in the medical unit of a post-acute or correctional facility. This role may include exposure to chemicals and blood-borne pathogens. This role routinely involves the use of both medical and standard office equipment. This position cannot be performed remotely.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. To perform the essential functions of this job, the employee is required to continually stand, and frequently bend, walk, twist, crouch, use hands to handle or feel, and reach with hands and arms. This position requires the ability to push, pull, and lift up to 50 pounds. Specific visual abilities required by this job include close vision and ability to adjust focus. The employee is required to work the full schedule which may range from five to fifteen hours per day, based on the unit requirements (i.e. patient census, staffing needs, etc.)
Rendevor Dialysis is an Equal-Opportunity Employer.
ABA Clinical Coordinator (Program Supervisor)
Clinical Research Coordinator Job 45 miles from Sacramento
Transform Lives with Us: ABA Program Supervisor ABA Clinical Coordinator (Program Supervisor) Salary: $66,560 + Bonuses Why You'll Love Working Here: - Competitive Compensation: Earn a rewarding salary with potential for bonuses.
- Comprehensive Benefits: Health, dental, vision insurance, 401k, and more.
- Professional Development: Supervision for BCBA certification and career advancement opportunities.
- Flexible Work-Life Balance: Enjoy 80 hours of PTO annually and flexible scheduling.
- State-of-the-Art Resources: Equipped with the latest technology, plus a cell phone and laptop.
- Meaningful Impact: Create and implement personalized ABA programs, collaborate with families, and mentor staff.
Your Role:
- Lead and supervise ABA programs to ensure client progress.
- Provide clinical training and support to a dedicated team.
- Foster a collaborative environment for family and team engagement.
What You Bring:
- Master's Degree in Applied Behavior Analysis, Psychology, or related field.
- 1-2+ years of clinical supervision experience.
- Bilingual in Spanish preferred.
- Excellent communication and analytical skills.
- Valid California Driver's License and clean driving record.
Join a team that's committed to making a difference. Apply now at ********************************* (http://*********************************) and start your journey with us!
Additional Information
BTA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity, sexual orientation, marital status, national origin, disability, age or covered veteran status
Clinical Research Coordinator - 238087
Clinical Research Coordinator Job In Sacramento, CA
Job Title: Clinical Research Coordinator (CRC) - Sacramento, CA
This position operates with general direction and provides administrative leadership for research trials and related studies within the Neurology department. The Clinical Research Coordinator (CRC) oversees industry-sponsored and investigator-initiated studies under the supervision of the PI and research team.
Key responsibilities include patient recruitment, screening, enrollment, scheduling, data collection, participant tracking, and invoicing. Additional duties may involve study start-up, budget negotiation, IRB submissions, modifications, renewals, preparing for audits, study closeouts, and maintaining regulatory documents.
The CRC works independently and with guidance from the PI and team. This grant-funded role is based in both office and clinic settings. Duties may shift based on workload and division needs.
Duties:
Clinical Research Coordination - Industry-Sponsored and Investigator-Initiated Research (85%)
Coordinate trials, including subject recruitment, screening, and follow-up.
Communicate with participants, manage correspondence, and arrange recruitment events.
Train and oversee technicians, ensuring task delegation is documented.
Travel for staff training and recruitment support.
Conduct assessments, collect and process data, and maintain compliance with protocols and regulations.
Manage study documentation, maintain financial accountability, and ensure accurate billing and reimbursement.
Prepare for audits and complete study closeouts.
Ancillary Clinical Research Support (5%)
Support study start-up, including preparing IRB submissions and budget negotiations.
Handle regulatory documentation and amendments, and coordinate annual study renewals and regulatory requirements.
Administrative Support & Meeting Coordination (5%)
Manage project supplies, grant materials, and meeting logistics.
Prepare agendas, minutes, and travel arrangements.
Assist with administrative and outreach tasks, including study materials preparation and data entry.
Required Skills/Experience:
Knowledge and experience with clinical research
Experience obtaining human research patient consent
CITI Biomedical Researcher human subjects and Good Clinical Practices training is required within 1 month of hire
Hazardous materials shipping and handling certification is required within 1 month of hire.
Ability to prioritize and coordinate many work assignments in the most efficient manner and meet deadlines with frequent interruptions
Prior experience with IRB protocol submission preferred.
Experience with Electronic Medical Records.
Clinical Research Professional certification from SoCRA or ACRP is preferred.
Clinical Research Coordinator - Oncology
Clinical Research Coordinator Job 10 miles from Sacramento
As one of the nation's largest nonprofit systems, CommonSpirit Health now has more than 2,200 care sites and 140 hospitals in 24 states. We serve some of the most diverse communities across the nation, and in each location, humankindness leads the way.
The CommonSpirit Health Research Institute offers comprehensive clinical research services and support for various research activities. Their primary focus includes multi-site clinical trials, local and large-scale data research, partnerships with industry and academia for technology and innovation research, physician-initiated research, resident-initiated research in teaching facilities, nurse-initiated research, and health sciences student-initiated research. The institute aims to provide start-to-finish research services and assist in advancing medical knowledge and patient care.
CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources CommonSpirit is committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside our hospitals and out in the community.
Responsibilities
The Clinical Research Associate (CRA) works with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM) to support the planning, implementation and coordination of clinical trials and other research projects managed by the CommonSpirit Health Research Institute. Duties may vary depending on the size and complexity to each study. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent assists with clinical trial or other research project coordination duties as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as CommonSpirit Health policy.
Coordinate and participate in site initiation and other sponsor-required training for all protocols.
Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols.
Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy.
Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or CommonSpirit Health.
To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
Attend investigator/coordinator meetings as required by study sponsors.
Serve as liaison between participants, physician investigators, sponsors of research, IRBs, CSHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
#LI-CSH
Qualifications
Minimum 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials.
Minimum 3 years of experience interacting with patients in a healthcare setting required.
Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
Current certificate of Human Subjects Protection and Good Clinical Practice training required.
Bachelor's degree in a science or health-related field or a combination of education and/or additional job-related experience in lieu of the degree, required.
Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
Experience in implementation of research protocols and clinical trials processes required.
Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
Lab processing experience required, Phlebotomy certification preferred.
Clinical Research Coordinator
Clinical Research Coordinator Job In Sacramento, CA
We are seeking a dedicated Clinical Research Coordinator to join our dynamic team. This role involves patient-facing duties, including screening, recruitment, and managing source documentation. You will document in EMR, order labs, and manage patient appointments. You will be responsible for screening, consenting, and enrolling patients on oncology trials and following them through the course of their therapy.
Responsibilities
* Screen, consent, and enroll patients in oncology trials.
* Manage patient visits and ensure questionnaires and research procedures are completed.
* Work with clinic staff to schedule appointments, such as EKGs or vitals.
* Ensure protocol compliance and timely completion of tasks.
* Interact with nursing staff and medical assistants.
* Collaborate with clinical staff for insurance authorizations and scheduling.
* Work closely with infusion nurses to arrange appointments.
* Assist patients with understanding their calendar of events and participation requirements.
Essential Skills
* Experience in patient study enrollment and managing study requirements.
* Ability to read protocols, notice side effects, and assist patients.
* Bachelor's degree in a relevant field.
* Proficiency in clinical research, patient pre-screening, oncology, and chart review.
* Strong organizational skills and attention to detail.
Additional Skills & Qualifications
* ACRC Exam/Certification reimbursement.
* ACRP membership fees covered and potential conference attendance.
* Tuition reimbursement programs available.
* Experience in dealing with oncology patients and understanding their needs.
Work Environment
The work involves various types of trials, including pharmaceutical-sponsored Phase I and II, some Phase III, investigator-led protocols, and trials funded by national clinical trial groups. The clinical group is divided into disease teams and works closely with data management staff. The position requires being on-site daily for office visits, with a typical schedule of Monday to Friday, 8 AM to 5 PM, with some flexibility based on the clinic schedule. Working in the Comprehensive Cancer Center offers a prestigious opportunity to be at the cutting edge of oncology research.
Pay and Benefits
The pay range for this position is $30.00 - $40.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Sacramento,CA.
Application Deadline
This position is anticipated to close on Feb 20, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Clinical Research Coordinator
Clinical Research Coordinator Job In Sacramento, CA
The Clinical Research Coordinator (CRC) works with the Research Institute Market Clinical Research Manager (MCRM) to support the planning, implementation and coordination of clinical trials and other research projects managed by the clients research Institute. Duties may vary depending on the size and complexity to each study. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent assists with clinical trial or other research project coordination duties as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as internal client policy.
Coordinate and participate in site initiation and other sponsor-required training for all protocols.
Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols.
Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and clients internal policy.
Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or client.
To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
Attend investigator/coordinator meetings as required by study sponsors.
Serve as liaison between participants, physician investigators, sponsors of research, IRBs, client internal administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
Qualifications:
Minimum 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials.
Minimum 3 years of experience interacting with patients in a healthcare setting required.
Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
Current certificate of Human Subjects Protection and Good Clinical Practice training required.
Bachelor's degree in a science or health-related field or a combination of education and/or additional job-related experience in lieu of the degree, required.
Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
Experience in implementation of research protocols and clinical trials processes required.
Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
Lab processing experience required, Phlebotomy certification preferred.