Manager, Clinical Trials - School of Medicine, Pediatrics
Clinical trials specialist job at Emory Healthcare
**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.
**Description**
JOB DESCRIPTION:
+ Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials.
+ Typically supervises a staff of 2 - 5 employees.
+ Trains new clinical trials staff. Tracks enrollment, sponsor payments, and salary.
+ Provides leadership in business development.
+ Assists residents in preparing research projects by facilitating IRB submissions and protocol writing.
+ Responsible for preparing NIH proposals and routing through the system.
+ Assists in creating and maintaining Standard Operating Procedures.
+ Performs related responsibilities as required.
MINIMUM QUALIFICATIONS:
+ A bachelor's degree in a related field and seven (7) years experience in clinical trials, two of which are in the clinical area.
+ A master's degree and four years of experience in clinical trials, one of which is in the clinical area will be considered equivalent.
NOTE: Position tasksaregenerallyrequired tobe performed in-person at an Emory University location. Remote workfrom homedayoptions may be grantedatdepartmentdiscretion.Emory reserves the right to changeremote workstatus with notice to employee.
\#LI-VJ1
**Additional Details**
Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD).
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.
**Connect With Us!**
Connect with us for general consideration!
**Job Number** _153803_
**Job Type** _Regular Full-Time_
**Division** _School Of Medicine_
**Department** _SOM: Peds: Innovation Research_
**Job Category** _Clinical Research_
**Campus Location (For Posting) : Location** _US-GA-Atlanta_
**_Location : Name_** _Emory Campus-Clifton Corridor_
**Remote Work Classification** _Primarily On Campus_
**Health and Safety Information** _Not Applicable_
Clinical Research Associate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives
Los Angeles, CA jobs
This is a hybrid per diem position offering flexibility to work between 0 and 40 hours per week, depending on departmental needs. Scheduling will be determined by the hiring manager in alignment with operational priorities. At this time, we can only consider applicants who are able to commute to our Los Angeles work location several times per week and who reside within a reasonable commuting distance.
The hybrid schedule typically consists of two remote workdays and three days spent either onsite or in the field, based on project and program requirements.
Preferred Qualification: Proficiency in the Thai language is strongly preferred.
Please note that per diem team members are not eligible for health benefits, but this role provides an excellent opportunity to gain valuable experience, contribute to meaningful work, and enjoy a flexible schedule.
Cedars-Sinai's Cancer Research Center for Health Equity (CRCHE) and Community Outreach & Engagement team are seeking a passionate and community-oriented Clinical Research Coordinator (CRC I) - Per Diem to support the implementation of the ASPIRE (Asian American Prospective Research) study. This important initiative focuses on advancing community-based research within the Thai community, helping to improve cancer prevention, screening, and health outcomes.
In this role, you will play a key part in developing community partnerships, engaging participants, and ensuring the successful implementation of ASPIRE's goals through culturally responsive outreach and collaboration.
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and Responsibilities
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Department Specific Duties & Responsibilities
5% - Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of non-complex research studies.
5% - Collects, evaluates, and abstracts clinical research data; may assist in designing data collection/abstraction tools. Enters and processes clinical research data into sponsor-provided Electronic Data Capture (EDC) systems.
5% - Completes Case Report Forms (CRFs) in accordance with study protocols and sponsor requirements.
5% - Assists with prescreening potential research participants for various clinical trials. Schedules participants for research visits and procedures. Provides supervised patient contact or independent contact for long-term follow-up participants.
5% - Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB), including the submission of Adverse Events, Serious Adverse Events, and Safety Letters per federal and local guidelines.
5% - Assists with clinical trial budgets, study-related billing, and patient research billing activities.
5% - Prepares and ships biological samples; maintains study supplies, kits, and inventory.
5% - Ensures compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, IRB requirements, HIPAA standards, and all institutional and federal guidelines. Maintains strict patient confidentiality.
5% - Serves as a point of contact for external sponsors for select trials; responds to sponsor inquiries and may attend meetings regarding study activity under supervision.
Additional Study-Specific Duties
Pulmonary Function Lab
Assists with prescreening of potential study participants.
Maintains organized paper and electronic research files.
Assists with preparing manuscripts, correspondence, and other research documents.
Conducts literature reviews to support study activities.
Neuroscience
Transports research medications according to protocol requirements.
Performs study-related assessments and participant questionnaires.
Maintains organized paper and electronic research files.
Assists with manuscript preparation and other research documentation needs.
Conducts literature reviews for ongoing and upcoming studies.
QualificationsRequirements:
High School Diploma/GED required.
Preferred:
Bachelor's Degree preferred.
Proficiency in the Thai language is strongly preferred.
1 year Clinical research related experience preferred.
Req ID : 13883
Working Title : Clinical Research Associate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives
Department : Cancer - Research Center Health Equity
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Manager, Research Operations
Beverly Hills, CA jobs
Responsible for the daily planning, organizing, directing and controlling of the operations of assigned area, in order to meet the needs of all customers, Faculty and support of Medical Center goals and philosophies. The Manager, Research Operations assumes fiscal responsibility through preparation of unit budgets, serves as liaison with Faculty and other personnel, promotes the maximum growth and development of each employee, supports research, participates in both strategic and tactical planning.
The Manager, Research Operations is accountable to the Department Chair and/or Institute Executive Director and serves as the primary source of information for the department. She/he maintains competency skills including the ability to interact with Faculty and staff within their assigned area, the Medical Center and throughout the Health System. The Manager, Research Operations plans, organizes, manages and controls the daily operations of their area and works closely with departmental leadership, Faculty, Principal Investigators (PIs), staff and students to provide analytical support and project management in fulfilling the established goals and objectives for the department and organization. Strategizes and collaborates with the Director and senior leadership, along with Academic Affairs regarding development and implementation of policies and procedures.
Manages and supervises administrative staff; provides leadership coaching, and opportunities for professional development. The Manager, Research Operations facilitates Human Resource (HR) functions for their area by collaborating with the appropriate HR partners for Faculty and department staff recruitment, visa and immigration assistance, employee relations, compensation, and benefits.
Primary Duties and Responsibilities
Ensures compliance with state and federal laws, accreditation, professional and regulatory agency standards and licensure requirements. Maintain staff compliance with medical center policies, procedures and protocols.
Assumes fiscal responsibility for the department including unit budget preparation, labor and supply cost management, and revenue enhancement.
Responsible for tracking and reporting all high-level Capital/Operations projects. Prepares complex or highlevel regular and ad-hoc financial reports for the Department Chair and/or Institute Executive Director. Works closely with leadership to develop processes and tools to monitor research funding and activities for the area.
In collaboration with the Department Chair, Institute Executive Director and/or Division Director develops business operations plans for department and for specific programs and services within it.
Supervises the research protocols as mandated for research and ensures optimal levels and continuous improvement of quality within their work area. Maintains appropriate quality management and oversight programs.
Supervises department employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, coaching, training (e.g. orientation, in-service and continuing education), evaluating performance, compensation, discipline and terminating employment.
Interact regularly with PIs and staff to assess team needs, provide information and resolve issues.
Promote a team atmosphere and manage staff regarding but not limited to the following: Manage the onboarding of new lab staff, Develop job descriptions, Conduct employee annual appraisals, Identify staffing needs, Conduct probationary period meetings with new staff, and Counsel, coach and terminate staff as appropriate.
In collaboration with the Institute Executive Director and/or Division Director, develops business and operations plans for department and for specific programs and services within it.
Manages the effective utilization of human resources and supplies within the department, including the development of appropriate staffing and management of productivity. Develop staffing plans in response to research and department activity. Recommend space and other resources for needed services. Participate in the selection of outside sources for needed services.
Collaborates with other research, department and clinical/support service managers in other areas to help foster cross-functional process improvement, collaborative teamwork, open communication and problem solving to ensure the effective coordination and integration of services within and between units.
Works closely with the Office of Research Administration and designated Research Grant Specialist to ensure all grant awards are appropriately managed and maintained for Faculty holding a primary appointment in the area.
Responsible for facilitating the Faculty contracting process in coordination with Academic Human Resources.
Performs all other duties as assigned.
Department-Specific Responsibilities
The successful candidate will provide strategic leadership and operational oversight for the Cancer Clinical Trials Office (CCTO), ensuring the highest standards of regulatory compliance, operational excellence, and program growth across Cedars-Sinai and the Samuel Oschin Cancer Center.
Clinical Operations & Regulatory Oversight
Provide leadership to ensure all clinical research activities comply with institutional, local, state, and federal regulations, including GCP, ICH, IRB, and NCI/CCSG requirements.
Oversee the structure, governance, and operational alignment of the CCTO with Cedars-Sinai Medical Center and the Samuel Oschin Cancer Center.
Ensure accuracy, quality, and timely reporting of clinical trial data across all CTMS, databases, and tracking systems, including adverse events, serious adverse events, and protocol deviations.
Perform routine quality checks and audits in collaboration with Quality Management to maintain robust QA/QC programs and support internal and external monitoring visits.
Program Leadership & Strategic Planning
Partner with Principal Investigators, disease teams, and CCTO leadership to advance clinical research initiatives, improve trial activation timelines, and increase patient accrual.
Generate and oversee protocol status reports and performance metrics for key stakeholders, including leadership, IRB, and clinical teams.
Lead initiatives to improve efficiency, streamline workflows, enhance communication, and support continuous process improvement across clinical research operations.
Support expansion of Cedars-Sinai's cancer clinical research programs across the broader cancer network in collaboration with institutional leadership.
People Management & Team Development
Lead, mentor, and evaluate clinical research staff, including hiring, onboarding, workload management, performance evaluations, and professional development.
Standardize training, tools, and processes across the Clinical Operations Unit to ensure consistency and operational excellence.
Foster an inclusive, collaborative, and high-performing team culture that supports professional growth and accountability.
Financial & Resource Management
Oversee clinical trials financial resources, including budget development, monitoring, and forecasting in collaboration with CCTO and SOCCI finance leadership.
Prepare and distribute operational and financial reports, including accrual metrics, audit activity, activation timelines, and budget performance.
Support enterprise-wide research administration initiatives and serve as a pilot for scalable clinical research support services as appropriate.
Stakeholder Engagement & Communication
Serve as a liaison between sponsors, CROs, disease teams, and institutional partners to ensure timely communication and resolution of protocol-related issues.
Build and maintain strong relationships with internal and external stakeholders, representing Cedars-Sinai with professionalism and integrity.
Teamwork, Leadership & Customer Relations
Collaborates effectively across multidisciplinary teams to solve problems and achieve shared goals
Establishes strong, trust-based relationships with stakeholders and customers
Demonstrates responsiveness, accountability, and inclusive practices
Shares expertise and supports team success across functions
Supervisory & Management Responsibilities
Directly supervises staff, including hiring, scheduling, performance management, and corrective action as needed
Plans and assigns work to ensure objectives are met within budget and timelines
Provides day-to-day leadership, guidance, and oversight to ensure high-quality outcomes
Qualifications
REQUIREMENTS
Bachelor's Degree in Business, Administration, Nursing, or equivalent work experience required
5 years of related supervisory or management experience, with increasing responsibility
Preferred Qualifications:
Master's Degree (MBA or MPH) strongly preferred
2 years of experience in finance or budget oversight. Knowledge of general accounting and financial analysis.
Knowledge of GAAP rules helpful
Req ID : 12570
Working Title : Clinical Research Manager, Research Operations
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Academic/Research Services
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $55.31 - $96.79
Clinical Research Program Manager (Operations)
Beverly Hills, CA jobs
Responsible for directing and managing a specified program within the clinical research operations unit, department, or division. Provides leadership, guidance and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance. Ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio. Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s).
Primary Duties and Responsibilities
Oversees and/or manages the assigned recognized organizational clinical research program and has authority for day-to-day program operations and administration. May be responsible for program development or expansion. Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives.
May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials declined by program or department leadership.
Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program. Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement potential solutions. May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program.
Interfaces with internal and external key stakeholders including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions.
Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives. Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program. Interfaces with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance.
Researches and analyzes data for evaluating performance of program or program operations, including quality assurance and trends. Makes recommendations to leadership and/or implements program changes based on findings. Provides data and/or summary findings to program participants, stakeholders, leadership, and/or cross-functional teams. Performs quality oversight of clinical trials to include monitoring progress of screening, enrollment, and data submission. Responsible for ensuring protocol compliance and training of staff supporting the program.
Plans and supports the department/program leaders during an audit, to include direction for audit prep and any required follow up post audit.
Evaluates requests for program exceptions or changes, and determines response, escalating as necessary.
Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and/or mentorship pertaining to the program. Provides regular Primary Duties and Responsibilities communication to departments and leaders across the organization. Notifies stakeholders of any changes to the program. May work with cross-functional teams across multiple departments to develop communication and training materials.
In conjunction with leadership, responsible for planning, monitoring, and managing program fiscal budgets and financials, and resolves or escalates issues.
Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures. May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and enhancements.
Monitors program to ensure appropriate governance and program compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program compliance with organizational policies and procedures. Monitors compliance reporting tools and provides summary status reports to the Research Manager, and other stakeholders.
May manage staff and/or lead the work of others, including some or all of the following: recruitment, onboarding/off-boarding, training, performance management and professional development of staff.
Department-Specific Responsibilities
Manage Disease Research Group (DRG) Meetings: Lead and coordinate DRG meetings, ensuring that all necessary information is addressed to support DRG functions. Maintain regular communication with DRG faculty to ensure alignment with DRG needs and future planning.
Clinical Issue Resolution: Engage with providers (physicians, advanced practice providers, clinic nurses, and staff) to ensure that clinical issues are identified and addressed promptly and in compliance with policies.
Promote Research Excellence: Advance clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
Training and Development:
Oversee the training and education of clinical research staff within the DRG/team.
Conduct baseline competency assessments for new hires, identify areas of opportunity, and develop individualized training plans.
Provide ongoing management of staff development, including competency assessments and continued education opportunities.
Contribute to the development and delivery of educational in-services to ensure high-quality clinical research performance.
Compliance and Quality Oversight:
Contribute to the development and monitoring of corrective action plans.
Ensure compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures.
Strategic Leadership: Actively participate in the strategic planning process of SOCCI's Cancer Clinical Trials Office (CCTO). Represent the CCTO on university and hospital committees and task forces as assigned.
Clinical Study Coordination:
Independently coordinate studies, including patient screening, informed consent (when IRB- and Nursing Institute-approved), and oversight of study assignments within the group.
Supervise research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements.
Develop and implement strategies to increase patient enrollment, improve efficiency, train personnel, and identify new research opportunities.
Specimen and Clinical Services:
Coordinate study participant tests and procedures as required, and handle research specimens (processing, shipping, tracking).
Perform phlebotomy services in accordance with CSMC policies and procedures, ensuring accurate specimen labeling and reporting of results.
Other Duties: Perform additional responsibilities as assigned to support departmental goals.
Qualifications
Required Qualifications
High School Diploma or GED.
Minimum 5 years of experience in management, program/project management, or a related field.
Minimum 3 years of experience in a clinical research or related industry setting.
Demonstrated experience managing a team, including direct supervision of staff, in a clinical research setting.
Familiarity with clinical research operations, including regulatory compliance, study coordination, and staff development.
Preferred Qualifications
Bachelor's degree in healthcare, management, or a related field.
At least 1 year of experience managing clinical trial operations.
Req ID : 11205
Working Title : Clinical Research Program Manager (Operations)
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $45.56 - $77.45
Clinical Research Associate I - Heart Institute
Los Angeles, CA jobs
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties & Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education:
High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or a related field.
Experience and Skills:
One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 9188
Working Title : Clinical Research Associate I - Heart Institute
Department : Heart Institute
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate II - Women's Research Program - Full-Time, On-Site
Los Angeles, CA jobs
Come join our team!
The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. May serve independently as study coordinator for minimal number of noncomplex research studies or projects.
What are the Primary Duties & Responsibilities?
Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies.
Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently.
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities.
Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives.
Qualifications
Education, Experience & License/Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
One (1) year of clinical research related experience required
Certification in Clinical Research (SOCRA or ACRP) preferred
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 13839
Working Title : Clinical Research Associate II - Women's Research Program - Full-Time, On-Site
Department : Womens Cancer Program - WCP
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $36.14
Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology
Beverly Hills, CA jobs
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
Dr. Ju Dong Yang, in Department of Medicine, Karsh Division of Gastroenterology and Hepatology is looking for a new Clinical Research Associate I to join the team!
The research program of Dr. Ju Dong Yang has been focused on clinical and translational research of liver cancer. Dr. Yang conducted several population-based cohort studies to describe recent trends in liver cancer epidemiology in the United States.
As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. This position will be responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I member may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Ensures compliance with protocol and overall clinical research objectives.
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Department-Specific Responsibilities:
May serve as one point of contact for external sponsors for select trials.
May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Qualifications
Education:
High School Diploma/GED is required.
Bachelor's degree in Science, Sociology, or related degree is preferred.
Licenses/Certifications:
ACRP/SoCRA certification is preferred.
Experience:
Clinical research experience is highly preferred.
Understanding of general research objectives.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 13803
Working Title : Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology
Department : Research - General Medicine
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Research Associate II - The Angeles Clinic & Research Institute
Los Angeles, CA jobs
Grow your career at Cedars-Sinai!
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Join our team and contribute to groundbreaking research.
The Research Associate II works at a high level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for ensuring timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations, where applicable.
Primary Duties and Responsibilities:
Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval.
Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process.
Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent.
Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial.
Ensures timely filing of annual renewals and amendment submissions to IRB.
Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines.
Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies.
Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB.
May help coordinate and prepare for institutional, pharmaceutical and internal audits.
Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires.
Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities.
Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals.
Participates in weekly research staff meetings.
Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process.
Performs administrative duties in a timely manner as assigned.
Qualifications
Requirements:
High School Diploma/GED required. Bachelor's degree preferred.
1 year Clinical research related experience required.
#Jobs-Indeed
#LI
Req ID : 13668
Working Title : Research Associate II - The Angeles Clinic & Research Institute
Department : Angeles Research Inst
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $34.64
Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program
Los Angeles, CA jobs
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
As a Clinical Research Associate I, you will work under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, pre-screening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.
Primary Job Duties and Responsibilities:
Collects, evaluates and/or abstracts clinical research data.
May assist in designing forms for data collection/abstraction.
Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Schedules research participants for research visits and research procedures.
Provides supervised patient contact or independent patient contact for long term follow-up patients only.
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient research billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinical research objectives.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May serve as one point of contact for external sponsors for select trials.
May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Department-Specific Duties:
Maintains CITI certification.
Compiles, analyzes, and presents work at internal meetings and conferences.
Performs data searches and other related administrative tasks.
Assists with research protocol writing and development.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for departmental clinical studies.
Assists with preparing manuscripts, letters, and other research documents as needed.
Coordinates study related activities and subject recruitment with Laboratory Staff.
Qualifications
Education:
High School Diploma/GED is required.
Bachelor's degree in Science, Sociology, or related degree is preferred.
Experience:
One year of clinical research related experience is preferred.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 13223
Working Title : Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program
Department : Associated Sci and Tech Program
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate I - Heart Institute - Makkar Lab
Los Angeles, CA jobs
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.
Primary Duties & Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Assists with prescreening of potential research participants for various clinical trials.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education:
High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred.
Experience and Skills:
No experience required. One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Req ID : 13060
Working Title : Clinical Research Associate I - Heart Institute - Makkar Lab
Department : Heart Institute
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate I - Butte Lab - Department of Neurosurgery (Per Diem)
Los Angeles, CA jobs
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
Dr. Pramod Butte, Ph.D. is looking for a Clinical Research Associate I to join a diverse team!
The primary focus of the Butte Laboratory is translational research in the field of bio-photonics. The Butte Lab is developing novel intra-operative imaging/visualization technologies to aid surgeons in achieving near-complete tumor excision. To learn more about the Butte Lab, please visit this website.
Serving as a Clinical Research Associate at Cedars-Sinai, you will assist in the effort in validating the clinical trial of groundbreaking medical imaging systems. The job will provide an outstanding opportunity to work with a multidisciplinary team involving optical engineers, mechanical engineers, electrical engineers, biomedical engineers as well as surgeons, pathologists, and other medical personnel. You will be involved in the development and possible commercialization of a novel medical device technology. Interest or experience in a start-up environment with an entrepreneurial spirit is highly desired. The position will provide experience as a part of a highly focused team on a broad array of technologies. In addition, the position will also offer experience with other technicians, with clinical trials, collecting clinical data, and play a crucial part in developing clinical protocols. The position will provide opportunity to work on medical technology with far reaching and immediate impact on patients' lives.
The CRA I member will work directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, provides limited patient contact as needed for study, and assists with study budget and patient research billing. This role will follow all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Schedules patients for research visits and research procedures.
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long-term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Department-Specific Duties and Responsibilities:
Obtains patient consent, if authorized, to participate in clinical study.
Engages with OR staff to ensure informed, accurate, and timely transport, scanning, and processing of specimens in the context of the clinical study.
Works with, handle, and process fresh and fixated specimens per outlined protocol Perform scanning of specimens using clinical prototypical imaging device(s).
Performs transport, set-up, tear-down of clinical equipment used in clinical study.
Qualifications
Education:
High School Diploma or GED, required.
Experience and Skills:
Understanding of general research objectives.
Experience in a clinical research setting is highly preferred.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 8933
Working Title : Clinical Research Associate I - Butte Lab - Department of Neurosurgery (Per Diem)
Department : Research - Neurosurgical
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate I - Community & Behavioral Health, Tan Lab (Onsite)
Los Angeles, CA jobs
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered.
Cedars-Sinai has an outstanding opportunity for an independent and well-organized contributor to serve as a CLINICAL RESEARCH ASSOCIATE to Dr. Judy Tan to support community-engaged research that develops behavioral and community-based health interventions for LGBTQ+ communities of color. Dr. Tan, Associate Professor, Cancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, is a social psychologist and applies her training in behavioral and prevention sciences to develop innovative interventions for improving health outcomes among marginalized populations in the U.S.
This position provides contributions to behavioral and implementation science for the Cancer Research Center for Health Equity. The scope of the work includes research involving participants recruited from the surrounding LA communities and interactions with community-based researchers, academic researchers, and local community organizations and health systems.
As Clinical Research Associate, you will be a vital member of an interdisciplinary team led by Dr. Tan, which includes a biostatistician, qualitative data researchers, as well as grant administrative and project management support staff members. Your role will be assisting with both quantitative and qualitative research projects, patient research engagement, and community liaison support. You will take lead roles on project activities, as identified by the team.
Data management, coordination, and analysis: (30%)
Assist with leading the creation and management of organized research project portfolio with project dashboard for data tracking.
Work independently to produce tables, charts, graphs for manuscript and grant preparation from sources including analyst reports, publicly available data, and literature searches.
Organize data storage and management for qualitative study (including interviews with cancer patients, caregivers, and affected community members).
Organize data storage and management for quantitative projects.
Execute basic data analysis (demographic tables, bivariate calculations, evaluation of missing data) of existing data sets to generate research approach and analytic plans.
Support process evaluation of a pilot smoking cessation program, including developing evaluation framework, creating and implementing a data collection plan.
Human subject research support: (20%)
Assist with leading the creation and management of study questionnaires in REDCap.
Identify and resolve quality issues with survey administration.
Manage revisions of REDCap instrument and protocol.
Triage data collection questions for immediate resolution or consultation with team, PI.
Assist with leading the development and submissions of IRB study applications, modifications, and renewals.
Assist with leading the compliance efforts for sponsoring entities.
Patient and stakeholder engagement: (20%)
Support the relationship (act as primary liaison) with community partners, through meeting scheduling, regular and proactive email communication, phone calls, and in-person meetings.
Support collaboration with community partners to develop and assess project implementation strategies, including outreach strategies, project materials, and workshop content.
Manage collaborative curriculum adaptation with multiple community partners.
Interact with patients via assisting with qualitative interviews and focus groups.
Writing & Grant Development (10%)
Assist with leading the development of project narrative/research plans for new grants, including timelines and schedules of deliverables.
Write portions of manuscripts in collaboration with the research team and community partners.
Provide copy-editing assistance with manuscripts.
Conduct independent literature searches and produce summaries to guide project development based on ongoing research findings and future steps.
Budget Management (5%)
Act as PI proxy in grant expense approvals and FTE certification.
Collaborate with department payroll and grant management staff to identify and address any expense errors.
Reconcile budgets monthly.
Create budget projections; identify budget surplus and deficits.
Ensure timely payment of community partner and other service provider invoices.
Assess appropriate budgets to charge for new research activities.
Website development & management (5%)
Develop content for website.
Edit content according to stakeholder (community partners') feedback)
Edit personal testimonial videos.
Respond to and track website inquiries.
Act as the primary liaison with graphic designer and web developers.
Other administrative duties as needed (5%)
Support Dr. Tan and project team with scheduling meetings
Plan and co-manage event logistics; act as primary liaison with on-site service providers.
Qualifications
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered.
Requirements:
High School Diploma or GED required
A cover letter explaining your interest in this opportunity and how it aligns with your career goals
Resume or CV
Preferred:
Bachelor's degree or equivalent experience in public health or related area.
At least 2 years of related experience post-undergraduate degree.
Excellent verbal and written communication skills.
Working knowledge of community-based research and organizing theories, frameworks, principles, and practices.
Experience with program evaluation, specifically process evaluation.
Experience managing complex, multi-stakeholder projects.
Experience working with marginalized populations related to health issues.
Strong interest in minority health & healthcare, racial disparities, social determinants of health with self- motivation for independent learning
Commitment to racial and LGBTQ+ justice.
Bachelor's level or equivalent analytic skills and understanding (SAS, Stata, R or equivalent).
Intermediate or higher level skills of MS Office suite.
Interview Process:
If selected for an interview, candidates may be asked to complete a brief writing sample and/or a short example exercise or task relevant to the position.
Req ID : 10622
Working Title : Clinical Research Associate I - Community & Behavioral Health, Tan Lab (Onsite)
Department : Cancer - Research Center Health Equity
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate I - Urology
Los Angeles, CA jobs
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only.
Primary Duties & Responsibilities:
• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets.
• Assists with patient research billing.
• Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs
Qualifications
Educational Requirements:
High School Diploma/GED
Bachelors degree in science or related degree preferred
Experience:
1-year clinical research related experience preferred
Physical Demands:
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Understanding of general clinical research objectives. Clinical research experience, preferred
Req ID : 13483
Working Title : Clinical Research Associate I - Urology
Department : Urology
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Data Specialist I - Heart Institute
Los Angeles, CA jobs
The Clinical Research Data Specialist I manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Manages data for research studies.
Designs forms for data collection.
Performs clinical data collection/abstraction.
Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
Produces project reports.
Maintains the accuracy, integrity and security of complex, large computerized records systems.
Understands regulations, policies, protocols and procedures to control and maintain accurate records .
Performs data searches and other related administrative tasks.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Qualifications
Educational Requirements:
Requires a bachelor's degree or equivalent in education, training and experience.
Masters in Public Health preferred
Experience:
• Analyst experience preferred - Able to multitask in a diverse and demanding environment with frequently shifting priorities.
• Proactive, extremely organized and detail oriented.
• Strong record of interpersonal engagement.
• Able to demonstrate the ability to balance both working independently and collaboratively.
Physical Demands:
• Able to perform moderate lifting.
• Able to sit, stand and walk for prolonged periods of time.
• Able to read papers and online documents.
• Able to operate standard office equipment.
• Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Req ID : 5528
Working Title : Clinical Research Data Specialist I - Heart Institute
Department : Heart Institute
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $39.76
Clinical Research Associate I - Regenerative Medicine Institute
Los Angeles, CA jobs
Join us as we translate today's discoveries, into tomorrow's medicine!
Regenerative medicine is a new and developing field that strives to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases, and we're extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I will work directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Additionally, this position will include animal work (injections, dissections, and surgery), sample processing, and cell culture.
Primary Job Duties and Responsibilities:
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Department-Specific Duties and Responsibilities:
Performs data searches and other related administrative tasks.
Assists with research protocol writing and development.
Transportation of research medications.
Performs study related assessments and questionnaires.
Assists with prescreening of potential research participants for various clinical trials.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor' inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.
Attends research meetings and monthly conference calls with sponsors for study updates.
Performs cell culture, immunohistochemistry including processing of samples.
Performs animal injections, dissections and surgery.
Assists with scheduling of visits and assessments.
Qualifications
Education:
High School Diploma or GED is required.
Experience and Skills:
Clinical Research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to follow regulations.
Must possess digital literacy, including Word and Excel, and the ability to use standard office equipment is required.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 12957
Working Title : Clinical Research Associate I - Regenerative Medicine Institute
Department : Research - RMI
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate I - CA Heart Foundation
Beverly Hills, CA jobs
Grow your career at Cedars-Sinai!
The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography.
In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.
Primary Duties & Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Assists with prescreening of potential research participants for various clinical trials.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education:
High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred.
Experience and Skills:
No experience required. One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Req ID : 13782
Working Title : Clinical Research Associate I - CA Heart Foundation
Department : CA Heart Foundation
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $33
Senior Clinical Coordinator
Pleasanton, CA jobs
Senior Clinical Research Coordinator
Full-Time - Day Shift
Advance the Future of Clinical Research
Are you passionate about clinical research and ready to take your expertise to the next level? At University Health, we're seeking a Senior Clinical Research Coordinator to lead and support high-impact studies that shape the future of patient care. This is a unique opportunity to bring your clinical insight and research experience to a role that supports innovation, compliance, and excellence in human subject research.
What You'll Do
As a Senior Clinical Research Coordinator , you'll play a vital leadership role in the coordination and review of complex human subject research protocols. You will:
Evaluate and provide expert clinical and risk assessment on research protocols and procedures
Assist the Director with implementing a robust Human Subjects Protection Program
Serve as a departmental representative to internal and external research committees, including IRB and OHRP
Coordinate, monitor, and educate staff on best practices in research compliance and study execution
Support grant applications, budgeting, and program planning across diverse research initiatives
What We're Looking For
Education & Experience:
Required:
Bachelor's of Science in Nursing (BSN) from an accredited institution
Minimum 3 years of clinical research experience
Working knowledge of research methods and federal regulations for human subject research
Must possess or qualify to obtain CCRP or CCRA certification within 6 months of hire
Core Competencies:
Strong leadership and judgment in confidential, regulatory, and ethical matters
Ability to navigate complex research protocols with a sharp eye for detail
Confident representing the department in multi-institutional settings
Excellent communication, planning, and coordination skills
Why Join Us?
At University Health, you'll be part of a team that is passionate about research, innovation, and improving patient outcomes. We offer:
A dynamic, collaborative, and mission-driven environment
Opportunities to lead and influence policy at the institutional and national levels
A commitment to professional development and clinical research excellence
The chance to make a real impact on groundbreaking studies and healthcare transformation
Ready to Elevate Clinical Research?
Bring your skills, passion, and vision to a team that's shaping the future of healthcare research. Apply today to become our Senior Clinical Research Coordinator.
Senior Clinical Trial Specialist - Remote Position
South San Francisco, CA jobs
The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required.
Major Duties/Responsibilities
* Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates
* Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries)
* Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes
* Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings
* Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable
* Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment
* Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance
* May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for:
* Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested
* Overseeing site recruitment, implementing appropriate contingency plans, as needed
* Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations
* Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs
* Mentors more junior staff
* Manages study team meetings in absence of Clinical Trial Manager
* Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial
Skills & Abilities
* Clear and timely communication, both written and verbal
* Ability to handle a moderate volume of highly complex tasks within an established timeframe
* Strong organizational skills and ability to prioritize
* Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff)
* Proactively identify and resolve/escalate project-related operational issues
* Ability to work independently on routine assignments, and take over new assignments based on previous experience
* Familiarity with word processing, spreadsheet and document management systems
Travel
Travel required up to 25%.
Education & Professional Experience
Required:
* Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field
* Strong understanding of GCP, ICH and knowledge of regulatory requirements
* Minimum one year prior Clinical Trial Specialist experience or commensurate
Preferred:
* One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing)
* Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities
* Oncology experience
* Global trial experience
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Physical Demands
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Compensation Range
The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.
At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
#LI-Remote
Senior Clinical Trials Specialist (Biotechnology Oncology)
Alameda, CA jobs
SUMMARY/JOB PURPOSE:
The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively
· Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL
· Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
· Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues
· Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
· Review compound-specific ICF and develop study-specific ICF templates
· Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
· Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents
· Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites
· May coordinate the preparation, conduct, and presentations at Investigator Meetings
· Review monitoring visit reports for completeness, accuracy, and adherence to the protocol
· Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation
· May conduct UAT for EDC / IRT and data listing review of EDC data for analysis
· Compile and review appendices for preparation of clinical study reports
· Review and/or create study documents (e.g. newsletters, and various study / site trackers)
· Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion
· Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately
· May assist in materials preparation for strategic governance discussions as required
SUPERVISORY RESPONSIBILITIES:
· None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
· BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or,
· MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or,
· Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
· Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research
Knowledge/Skills:
· Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
· Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
· Experience with development of prospective site-selection criteria
· Familiar with medical terminology, and basic concepts of clinical research
· Ability to deal with time demands, incomplete information or unexpected events
· Experience in interactions with outside vendors, e.g., CROs and contract labs
· Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
· Applies technical standards, principles, theories, concepts and techniques
· Advanced computer skills
· Good organizational and planning skills
· Strong interpersonal skills and communication skills (both written and oral)
· Ability to work effectively in a team/matrix environment
· Ability to understand technical, scientific and medical information
· Demonstrated success in problem-solving
· Self-motivation, eagerness to grow professionally and commitment to self-development
JOB COMPLEXITY:
· Works on assigned problems of moderate scope with analysis of situation or data required.
· Exercises judgment within defined procedures and practices to determine appropriate action.
· Builds productive internal and external working relationships.
· Uses professional concepts and company policies and procedures to solve a variety of routine problems.
· Demonstrated professional collaboration skills
· Capable of identifying task-related challenges and prioritizing activity accordingly
DESIRED BEHAVIORS:
· Resilient in the context of a rapidly changing environment
· Organized with a systematic approach to prioritization
· Works independently to meet objectives and completes tasks within established timelines.
· Expresses curiosity, asks questions and shares perspective, appropriately
EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS:
· We drive for results, so patients can survive and thrive.
· We are resilient in the face of adversity, and tireless in advancing our science.
· We celebrate our long history of prolific drug discovery and rigorous drug development.
· We unite to launch innovative medicines for difficult-to-treat cancers.
· We exist to give people hope - one drug, one patient at a time.
· We are Exelixis.
LIVES THE EXELIXIS CORE VALUES DAILY:
· Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),
· Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results)
· Excel for Patients (Innovate to design solutions and remove barriers to show how much we care)
WORKING CONDITIONS:
· Travel may be required up to 20% in support of clinical study activities
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyResearch Administrator, Pre/Post Award III - School of Medicine - Pediatrics
Clinical trials specialist job at Emory Healthcare
**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.
**Description**
JOB DESCRIPTION: Supports the day-to-day activities of a team of Pre and Post-Award Specialists. Monitors workload distribution and raises any concerns to the Research Administration Services (RAS) director. Provides guidance to team members, as appropriate. Uses knowledge of grant and contract management rules and regulations, technical expertise, analytical skills and knowledge of Standard Operating Procedures (SOPs) and awareness of federal rules and regulations related to research grant and contract activity. Post-award activities include regular review, reconciliation, and projection of award finances, preparing adjustments and corrections to award budgets, preparing financial reports, and at the end of the award, ensuring all financial requirements have been met and closing out the award. Creates high-quality written reports. Upon award acceptance, defines account establishment parameters, including billing and reporting requirements, budget, and cost sharing obligations. Sets up award in financial system. Distributes award information to PIs, co-PIs and relevant staff and other RAS units. Coordinates with relevant individuals to adjust payroll for all budgeted positions (including relative cost sharing positions). Reviews and reconciles award expenditures and budgets, adjusting, as necessary. Projects and forecasts future award expenditures. Manages budget, reporting and compliance timelines through the lifecycle of the grant or contract. Communicates with PIs on a regular basis regarding budget and expense adjustments and revisions. Completes financial reports to be sent to sponsor, as required by the award terms and conditions. Monitors compliance with agency and University regulations regarding reporting. Completes invoice and submits to sponsor (for certain award types only). Assists PIs with non-financial report submissions, as necessary. Coordinates and submits requests for No Cost Extensions, Carryover, rebudgeting requests, changes in scope, and other changes to the award; ensures all requests are done in compliance with sponsor guidelines and University policies. Facilitates the approval of invoices to pay subcontractors. Reviews effort reports and manages quarterly effort certification process for assigned units. Applies federal and university rules to management of effort allocation appropriately for individuals compensated whole or in part from federal awards. Assists in transferring awards out of the university. Closes out all funded projects consistent with university process and timelines. Pre-award activities include assisting departmental faculty/PI in the development, preparation, and submission of grant and contract proposals. Ensures all applications meet agency and university guidelines and published timetables and deadlines, including management of the Just-In-Time process. Ensures proposals are entered and routed in a timely manner for further review. Confers with PI and Pre-award support staff at collaborating institutions to secure necessary sub-awards documents for proposals. Assists the PI in the development of budgets and budget justification which includes proofing the budget for inconsistencies and ensuring accuracy. Reviews budgets for consistency with sponsor, monitors compliance with agency and University regulations regarding submission; verifies all financial information to include application of the appropriate overhead rate for the project. Advises the PI on administrative requirements in preparing proposal submissions and on budget adjustments and revisions necessary to meet the sponsor requirements. Coordinates and reviews certain proposal elements (biosketches and facilities & resources) for consistency, accuracy, and completeness. Reviews proposals for consistency with sponsor guidelines on budget, format, font size, page limits excluding narrative content (obtain and review sponsor guidelines). Monitors and facilitates proposal process through the routing process in compliance with University procedures and institutional signatures. Obtains signatures as needed. Monitors proposal status and advises PI on requirements and deadlines associated with research protection protocols. Works with colleagues/team members to jointly solve questions and challenges in their daily work. Interacts regularly with and provides high quality customer service to faculty members conducting sponsored research. Ensures adherence to quality standards and all policies and award regulations. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree and five years of experience related to grants and contracts management OR an equivalent combination of education, training and experience. Knowledge of federal rules and regulations/terms and conditions relating to research grant and/or contract activity. Knowledge of the PeopleSoft Financial System preferred. Proficiency with MS Office Suite software.
**Additional Details**
Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD).
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.
**Connect With Us!**
Connect with us for general consideration!
**Job Number** _156271_
**Job Type** _Regular Full-Time_
**Division** _School Of Medicine_
**Department** _SOM: Pediatrics RAS_
**Job Category** _Research Administration_
**Campus Location (For Posting) : Location** _US-GA-Atlanta_
**_Location : Name_** _Emory Campus-Clifton Corridor_
**Remote Work Classification** _Full Remote - Monthly_
**Health and Safety Information** _Not Applicable_