clinical research associate

Alliance for Clinical Trials in Oncology

<div>
 
 The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
 
 
 In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.
 
 
 The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.
 
 
 Benefits of working at the Alliance for Clinical Trials in Oncology Foundation{{:}}
 
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 8 weeks of paid time off (including PTO, sick, and holidays) during year one
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 Medical, Dental &amp; Vision plans with a 100% employer-paid option for employees
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 Tuition reimbursement stipends
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 Continuing Education
 </li>
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 3% employer match for retirement investments
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 Annual Employee Performance Bonus Program
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 Annual Cost of Living Adjustment
 </li>
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 50% commuter reimbursement
 </li>
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 Healthy Work/Life balance and flexibility
 
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 </ul>
 
 
 ROLE AND RESPONSIBILITIES
 
 
 
 &bull; Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
 
 
 &bull; Send, track, and review study-specific and global feasibility questionnaires.
 
 
 &bull; Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
 
 
 &bull; Track training information and issue trainings for sites and contacts.
 
 
 &bull; Collection of essential documents related to study start-up and review IP release packages.
 
 
 &bull; Prepare for and execute Investigator meetings and other site training programs.
 
 
 &bull; Assist with creation of start-up plans and templates.
 
 
 &bull; Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
 
 
 &bull; Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
 
 
 &bull; Accurately enter and manage data within the Clinical Trial Management System (CTMS) by{{:}} tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
 
 
 &bull; Participate in co-monitoring activities.
 
 
 &bull; Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
 
 
 &bull; Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
 
 
 &bull; Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
 
 
 &bull; Other related duties as assigned to meet departmental and company objectives.
 
 
 
 
 Requirements
 
 
 
 
 
 QUALIFICATIONS AND EDUCATION REQUIREMENTS
 
 
 
 &bull; A minimum of a BA/BS degree is required.
 
 
 &bull; Degree in a health or science major preferred.
 
 
 &bull; 2 - 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
 
 
 &bull; Working knowledge of clinical monitoring responsibilities and procedures.
 
 
 &bull; Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
 
 
 &bull; Proficient in Microsoft Office Suite, especially Word and Excel.
 
 
 
 PREFERRED SKILLS
 
 
 
 &bull; Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
 
 
 &bull; Strong interpersonal, written, and verbal communication skills.
 
 
 &bull; Flexible and adaptable to a small business workplace environment.
 
</div>

Clinical Research Associate

City of Hope

<div><div>Join the forefront of groundbreaking research at City of Hope where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
City of Hope has a Clinical Research Associate II (CRA II) opportunity available. The CRA II manages an assigned set of multiple research protocols to assure efficiency and regulatory compliance of the protocol, attending clinic as needed.
As a successful candidate, you will:<ul><li>
Conduct protocol management for an assigned set of multiple research protocols.</li><li>
Maintain current and accurate protocol documentation; notify investigators of pertinent protocol changes.</li><li>
Ensure that patients are appropriately registered; maintain documentation of patient registration.</li><li>
Compile and submits data on appropriate forms according to protocol requirements.</li><li>
Ensure protocol compliance with intense monitoring of specific study requirements and schedules protocol related treatment and tests.</li><li>
Plays active role in recruitment of patients to study.</li><li>
Train and mentor new clinical research staff members.</li><li>
Collect and deliver specimens for analysis, using appropriate or specified equipment for collecting and handling specimens.</li><li>
Works with physician or nurse to see that protocol related tests and evaluations are ordered per protocol guidelines.</li></ul></div><div>
Your qualifications should include:<ul><li>
Associate&rsquo;s degree.</li><li>
Experience may substitute for minimum education requirements.</li><li>
One year of experience working in a health care setting, preferably in research.</li><li>
Must have a minimum of 6 months experience/training as a CRA I at the City of Hope.</li></ul>
Preferred qualifications:<ul><li>
Bachelor's degree.</li><li>
Familiarity with medical records, health information systems, or related health field.</li></ul>
Additional Information:<ul><li>
COH employees may apply for a transfer or promotion to job openings for which they meet the minimum qualifications if they meet the following criteria:</li><li>
Employed at COH in current role for at least 6 months, unless otherwise stipulated in an applicable collective bargaining agreement.</li><li>
Are in good standing and have no current performance issues.</li></ul>
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, please CLICK HERE.</div></div>

Clinical Research Associate II

The Emmes Company, LLC

<div>Overview:
<div>
Clinical Research Associate II 
 
Be Part of One Team, One Purpose. 
 
At Emmes Group, we&rsquo;re shaping the future of clinical research&mdash;where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we&rsquo;ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. 
 
Through our two business units&mdash;Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions &mdash;we are modernizing clinical trials and accelerating the development of life-changing therapies. 
 
We believe that every clinical breakthrough starts with people&mdash;people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. 
 
The Clinical Research Associate (CRA) II is responsible for monitoring clinical study sites either onsite at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP.</div>
Responsibilities:
<ul><li>Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.</li><li>
As part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.</li><li>
Documents observations and monitoring activities in a site visit report at the conclusion of the visit.</li><li>
Facilitates and oversees Action Item resolution post visit.</li><li>
Helps to ensure that clinical sites are conducting the study in compliance with protocol clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.</li><li>
Provides training and retraining to site staff including protocol, GCP GDP, and other training under direction from the project CRA staff oversight lead.</li><li>
Identifies areas requiring follow up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.</li><li>
Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures</li><li>
Serves as point of contact for study site personnel to answer questions and resolve studyrelated issues under the direction of the project CRA staff oversight lead.</li><li>
May assist with the development and or review of study related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.</li><li>
Prepares for and attends project team meetings and provides updates on project status and site specific performance</li><li>
Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines.</li><li>
Participates in Investigator Meetings or other client meetings as needed.</li><li>
Assists with filing and archiving of study documents.</li><li>
Assists in preparing sites for audits and may provide support and cooperation during audits inspections including translation to Auditor if needed.</li><li>
May assist with coordination of clinical study supplies.</li><li>
May assist with submission of applications notifications to Institutional Review Board IRB Ethics Committee EC Regulatory Authority.</li><li>
May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.</li><li>
Performs site management activities as required</li><li>
Performs other duties as assigned</li><li>
Complies with all policies and standards</li></ul>
Qualifications:
<ul><li>Bachelor's Degree Scientific discipline preferred or equivalent work experience Required</li><li>
1-3 years 1-2 years of relevant monitoring experience (on-site and remote) Required</li><li>
Proficient with MS Office Suite High</li><li>
Excellent computer and organizational skills High</li><li>
High level of attention to detail required High</li><li>
Ability to work on varying projects and exercise critical thinking High</li><li>
self starter who can work remotely and a team player who can work cross functionally with some oversight High</li><li>
Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA High</li><li>
Excellent organizational, interpersonal, and communication skills both oral and written High</li><li>
Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High</li><li>
Knowledgeable in prioritization, problem solving, organization, critical thinking, decisionmaking, time management, and planning activities High</li><li>
Ability to collaborate with internal and external colleagues and work well in a team oriented setting High</li></ul><div></div><div> 
If you&rsquo;re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose. 
 
CONNECT WITH US! 
Find us on LinkedIn:/the-emmes-group/ 
Visit our website:https://www.theemmesgroup.com/</div></div>

Oregon Health & Science University

<div>
 
 Department Overview
 
 
 
 Therapeutic Intervention Clinical Research Associate position in the Parkinson Center and Movement Disorders Division, Department of Neurology. Responsible for completing the study start-up activities for clinical trials, in collaboration with the Research Administrator. Provides leadership, training, and guidance to junior research assistants through written and in person instruction. Serves as lead study coordinator on assigned clinical trials. Supports Research Administrator, Administrative Director, and Center Director in tasks related to clinical trials and the research assistant team.
 
 
 <ul>
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 Please include a cover letter with your resume.
 
 
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 </ul>
 
 Function/Duties of Position
 
 
 
 
 Study start-up
 
 : In collaboration with Research Administrator, responsible for all components of clinical research trial start up for Movement Disorders. Includes completing feasibility questionnaires and site selection visits (on site or remote), facilitating completion of confidentiality disclosures, central and local IRB submissions, OnCore setup, coordination of services with other internal and external departments and vendors, and coordinating and attending site initiation visits.
 
 
 
 Study Coordination:
 
 With occasional supervision, coordinate and conduct complex study visits involving multiple staff and hospital services, including but not limited to &ndash; recruitment, scheduling, obtaining informed consent; lab sample collection and processing, conducting and/or assisting with study procedures (vital signs, ECGs, lumbar punctures, &amp; skin punch biopsies), data entry, and regulatory document submission to central and local IRBs. Effective and professional communication (written/electronic and verbal) with study team, study participants, sponsors, contract research organizations (CRO), investigators, Institutional Review Boards (IRBs), and other departments at OHSU. Preparation for and coordination of external monitoring visits.
 
 
 
 Lead &amp; Train
 
 : In collaboration with Research Administrator, onboard, train, and advise junior research assistants, create and maintain written training materials for research team, review and revise Standard Operating Procedures (SOPs), serve as point of contact for all research assistants and investigators with questions and concerns related to clinical trials and regulatory requirements.
 
 
 
 Education &amp; Communication
 
 : Attend weekly meeting with Research Administrator, lead weekly research team meeting, participate in monthly research meeting with Center Director, monitor changes to university and industry standards for clinical trial compliance.
 
 
 
 Additional Support
 
 : Support Research Administrator in tasks related to clinical trial operations and research team, including hiring, clinical trial invoicing, and other duties as assigned.
 
 
 
 Required Qualifications
 
 
 
 <ul>
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 Master&rsquo;s degree in relevant field AND 3 years of clinical research coordination experience OR; Bachelor&rsquo;s degree in relevant field AND 5 years of clinical research coordination experience
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 Clinical research coordination, including primary responsibility for multiple complex clinical trials and regulatory document maintenance, in role(s) with minimal oversight
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 Experience using electronic medical records system(s)
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 Experience with independent IRB submissions (initial submissions, modifications, &amp;/or annual review)
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 Clinical skills, such as specimen processing, ECG, &amp; vital signs measurements
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 Knowledge of clinical research regulatory standards and guidelines
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 Extremely well-organized with high attention to detail
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 Able to efficiently manage multiple tasks and demands with competing deadlines
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 A self-starter, able to work independently while being effective and efficient
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 Excellent written and verbal communication skills
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 Enjoys collaborating with and supporting colleagues in a team environment
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 SOCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification required within 12 months of hire
 
 
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 </ul>
 
 Preferred Qualifications
 
 
 
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 Experience using the Epic medical record system
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 Familiarity with procedures of the OHSU Institutional Review Board
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 Phlebotomy certification, or a desire to obtain one within 3 months of hire
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 Experience working with a senior population
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 Completion of CITI (Collaborative Institutional Training Initiative) courses &ndash; Good Clinical Practice, Human Subjects Research, &amp; Responsible Conduct of Research
 
 
 </li>
 </ul>
 
 Additional Details
 
 
 
 Primary work location is on campus, interacting with research participants, the research team, and study data. Occasional opportunities to work remotely. Working with human biological samples is required. In-person attendance at and participation in community events (approx. 6 per year), many of which occur on the weekend.
 
 
 Physical Demands: Ability to stand and walk throughout the OHSU campus for long periods of time during study visits.
 
 
 
 Why apply to OHSU?
 
 
 
 
 We are Oregon's only public academic health center.
 
 
 
 In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington.
 
 
 
 All are welcome.
 
 
 
 OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply.
 
 
 To request reasonable accommodation, contact askhr@ohsu.edu
</div>

TI Clinical Research Associate

IQVIA

<div>
 
 
 IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and will also consider CRA 1 candidates with a minimum of 6 months on-site monitoring experience. Must have experience monitoring in oncology solid tumor.
 
 
 
 
 
 IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
 
 
 
 
 Job Overview
 
 
 
 We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Conduct all types of site visits&mdash;selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
 </li>
 <li>
 Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
 </li>
 <li>
 Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
 </li>
 <li>
 Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
 </li>
 <li>
 Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
 </li>
 <li>
 Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
 </li>
 <li>
 Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
 </li>
 <li>
 Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
 </li>
 <li>
 Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in life sciences or health-related field (or equivalent experience).
 </li>
 <li>
 Requires at least 1 year of on-site monitoring experience.
 </li>
 <li>
 Strong understanding of GCP, ICH guidelines, and regulatory requirements.
 </li>
 <li>
 Ability to travel as required by the project.
 
 
 </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 
 
 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
 
 
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
 
 
 The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
</div>

Clinical Research Associate, IQVIA Biotech

Parexel

<div>Key Accountabilities:
Oversight of Monitoring Responsibilities and Study Conduct<ul><li>
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
</li><li>Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
</li></ul><ul><li>During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
 </li><li>Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation andrecruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level</li><li>
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
</li><li>Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
</li><li>Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
</li><li>Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
</li><li>Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines</li></ul> 
 Skills:
<ul><li>Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
</li><li>Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
 </li><li>Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
</li><li>Global clinical trial experience
</li><li>Must be fluent in English
 </li><li>Significant travel across whole Turkey
</li><li>Valid driver&rsquo;s license and passport required</li></ul> 
Knowledge and Experience:<ul><li>
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
 </li><li>Demonstrated knowledge of global and local regulatory requirements
</li><li>Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
</li><li>Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)</li><li>
Demonstrated ability to support sponsor regulatory interactions/inspections
</li><li>Demonstrated knowledge of the processes around protocol design and feasibility assessment</li></ul><ul><li>
Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery</li><li>
Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation</li></ul> 
Education:
<ul><li>Bachelor&rsquo;s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent</li></ul> 
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Senior Clinical Research Associate I - FSP

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Clinical Research Associate

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Clinical Research Associate, IQVIA Biotech

Senior Clinical Research Associate I - FSP