clinical research management associate

RTI LABORATORIES

Job Summary We are seeking a dynamic and detail-oriented Clinical Research Associate (CRA) to join our innovative clinical development team. In this vital role, you will oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory standards and study protocols. Your expertise will drive the successful management of clinical research projects, ensuring data integrity, patient safety, and adherence to all applicable regulations. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative and fast-paced environment.Responsibilities<ul><li>Coordinate and monitor clinical trials across multiple sites, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and company standards. </li><li>Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify compliance and data accuracy. </li><li>Review and verify source documents, case report forms (CRFs), and other trial documentation for completeness and accuracy. </li><li>Provide training and support to site staff on protocol procedures, data collection methods, EMR systems, and regulatory requirements. </li><li>Monitor patient safety by reviewing adverse event reports, ensuring proper documentation, and reporting to relevant authorities as required. </li><li>Manage trial documentation including ethics submissions, informed consent forms, regulatory binders, and audit readiness files. </li><li>Collaborate with cross-functional teams such as clinical operations, data management, laboratory personnel, and medical staff to facilitate smooth trial execution. </li><li>Ensure compliance with HIPAA regulations concerning patient confidentiality and data security. </li><li>Assist in the review of clinical laboratory results, vital signs data, blood sampling procedures (phlebotomy), and other clinical assessments. </li><li>Support statistical analysis activities by coordinating with statisticians using software tools designed for clinical data analysis. </li><li>Maintain detailed records of site communications, monitoring reports, and trial progress for audit purposes.</li></ul>Experience<ul><li>Proven supervising experience in managing clinical trials or overseeing clinical research teams. </li><li>Extensive knowledge of clinical trials management processes from initiation through close-out phases. </li><li>Strong understanding of medical terminology, FDA regulations, ICH GCP guidelines, and CDISC standards for data exchange. </li><li>Hands-on experience with EMR systems and electronic data capture (EDC) platforms for efficient data management. </li><li>Background in nursing or clinical laboratory work (including blood sampling and vital signs measurement) is highly desirable. </li><li>Familiarity with statistical software used in clinical research for data analysis purposes. </li><li>Certification such as ICH GCP certificate from a recognized issuer (including CA) is required; additional certifications in HIPAA compliance or phlebotomy are a plus. </li><li>Excellent analysis skills combined with meticulous attention to detail to ensure high-quality documentation review and compliance management. Join us in advancing medical science through rigorous research practices! We value energetic professionals committed to excellence in clinical development who thrive in collaborative environments dedicated to improving patient outcomes worldwide.</li></ul>Pay: $51,498.23 - $62,019.38 per yearWork Location: In person

Clinical Research Associate

University of Texas at Austin

<div>Job Posting Title:
Clinical Research Associate I
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Hiring Department:
Department of Psychiatry
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Position Open To:
All Applicants
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Weekly Scheduled Hours:
40
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FLSA Status:
Exempt
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Earliest Start Date:
Immediately
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Position Duration:
Expected to Continue Until Sep 01, 2027
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Location:
AUSTIN, TX
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Job Details:<h2 class="jobSectionHeader">
General Notes</h2>
This is a grant-funded position with an end date of September 1, 2027, renewable based upon availability of funding, work performance, and progress toward research goals.<h2 class="jobSectionHeader">
Purpose</h2>
The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.
The Clinical Research Associate I will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI). This role may coordinate the data collection and operations of multiple concurrent clinical research studies under the guidelines of research protocols, The University of Texas at Austin, and regulatory agency policies.
A successful candidate will possess strong attention to detail; excellent interpersonal, verbal, and written communication skills; the ability to coordinate with subjects, team members, other departments, and external institutions; the ability to multitask in a fast-paced environment while working with a diverse subject population; and the ability to prioritize and complete multiple projects within established deadlines.<h2 class="jobSectionHeader">
Responsibilities</h2>
Site Management &amp; Study Execution<ul><li>
Conduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution.</li><li>
Ensure compliance with study protocols and regulatory requirements.</li><li>
Manage site performance and resolve issues.</li><li>
Administer questionnaires, collect medical history, and perform study procedures.</li><li>
Maintain rapport with participants to support retention and address concerns.</li><li>
Obtain informed consent and ensure participant safety throughout protocol procedures.</li><li>
Coordinate with affiliated departments and external collaborators.</li></ul>
Data Collection &amp; Management<ul><li>
Collect and verify data from clinical sites.</li><li>
Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).</li><li>
Review and resolve data queries.</li><li>
Assist with manuscript and grant preparation, including opportunities for authorship.</li><li>
Maintain and update study databases and data collection forms.</li></ul>
Regulatory Compliance &amp; Oversight<ul><li>
Ensure adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.</li><li>
Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.</li><li>
Prepare and maintain regulatory documents.</li><li>
Coordinate with ethics committees to safeguard participant rights.</li><li>
Participate in internal and external audits and protocol reviews.</li></ul>
Participant Recruitment &amp; Retention<ul><li>
Evaluate medical records and perform screenings to identify eligible study participants.</li><li>
Assist in screening and enrolling study participants.</li><li>
Maintain communication with participants to support retention.</li><li>
Address participant concerns and inquiries.</li></ul>
Reporting &amp; Documentation<ul><li>
Prepare study reports and documentation.</li><li>
Maintain accurate records of study activities.</li><li>
Assist in the preparation of manuscripts and publications.</li></ul>
Marginal or Periodic Functions<ul><li>
Conduct literature reviews to support study design and protocol development.</li><li>
Assist in training new site staff and research team members.</li><li>
Participate in internal and external audits.</li><li>
Support development of study protocols and case report forms.</li><li>
Attend conferences and workshops to stay updated on industry trends.</li><li>
Adhere to internal controls and reporting structure.</li><li>
Perform related duties as required.</li></ul>
Knowledge, Skills, and Abilities<ul><li>
Maintain organized records, follow detailed procedures, and double-check work for accuracy.</li><li>
Write clear and concise reports, actively listen, and present information effectively.</li><li>
Analyze information, develop solutions, and implement corrective actions.</li><li>
Collaborate with team members and support team decisions.</li><li>
Prioritize tasks, set realistic deadlines, and manage time effectively.</li></ul><h2 class="jobSectionHeader">
Required Qualifications</h2><ul><li>
Bachelor&rsquo;s degree in life sciences, nursing, or a related field</li><li>
One year of relevant clinical research experience</li><li>
Familiarity with IRB processes and human subjects protection standards</li><li>
Experience with electronic data capture systems (e.g., REDCap)</li></ul>
Relevant education and experience may be substituted as appropriate.<h2 class="jobSectionHeader">
Preferred Qualifications</h2><ul><li>
Master&rsquo;s degree in life sciences, nursing, or a related field with at least two years of clinical research experience, preferably involving pediatric or neurodevelopmental populations</li><li>
Experience with statistical software (e.g., R, SAS, SPSS)</li><li>
Experience presenting research findings or contributing to publications</li><li>
Completion of Human Subjects Protection Training</li><li>
Experience working with children and families affected by neurodevelopmental disorders</li><li>
Strong written and verbal communication skills</li><li>
Ability to abstract data from medical records and manage complex databases</li><li>
Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)</li></ul><h2 class="jobSectionHeader">
Working Conditions</h2><ul><li>
May work around standard office conditions</li><li>
Repetitive use of a keyboard at a workstation</li><li>
Occasional weekend, overtime, and evening work to meet deadlines</li><li>
Occasional interstate, intrastate, and international travel</li><li>
This position will be assigned on-campus with an expectation to report to work on-site during the scheduled work week.</li></ul><h2 class="jobSectionHeader">
Required Materials</h2><ul><li>
Resume/CV</li><li>
3 work references with their contact information; at least one reference should be from a supervisor</li><li>
Letter of interest</li></ul>
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.
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Employment Eligibility:
Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.
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Retirement Plan Eligibility:
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
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Background Checks:
A criminal history background check will be required for finalist(s) under consideration for this position.
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Equal Opportunity Employer:
The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
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Pay Transparency:
The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor&rsquo;s legal duty to furnish information.
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Employment Eligibility Verification:
If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.
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E-Verify:
The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university&rsquo;s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:<ul><li>
E-Verify Poster (English and Spanish) [PDF]</li><li>
Right to Work Poster (English) [PDF]</li><li>
Right to Work Poster (Spanish) [PDF]</li></ul>
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Compliance:
Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.
The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.</div>

Clinical Research Associate I

ICON plc

<div>Clinical Research Associate - California
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.
What You Will Do:
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. 
 
Key responsibilities include:<ul><li>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</li><li>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</li><li>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</li><li>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</li><li>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</li></ul>
Your Profile:
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:<ul><li>
Various annual leave entitlements</li><li>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</li><li>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</li><li>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know<div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div>

<div>Clinical Research Associate, Sponsor Dedicated
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. 
 
Key responsibilities include:<ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul>
Your Profile:
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:<ul><li>
Various annual leave entitlements</li><li>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</li><li>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</li><li>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know<div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div>

Clinical Research Associate, Sponsor Dedicated

Stanford University

<div>The Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition, is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies within the Stanford Medicine Children&rsquo;s Health Center for Pediatric IBD and Celiac Disease. This is an exciting opportunity for a talented individual to contribute to groundbreaking research in the field of pediatric gastroenterology while working in a collaborative and supportive environment. Join us in making a real difference in the lives of young patients and advancing the science of pediatric IBD and celiac disease! 
The CRCA will coordinate complex aspects of multiple clinical studies and work under the general direction of multiple principal investigators and/or supervisor. The CRCA will support federal and non-federal clinical research studies including epidemiological and investigative work in support of clinical trials, clinical research or biomedical research focusing on &ldquo;bench to bedside&rdquo; technology. The primary work will include supporting pilot studies of Pediatric Gastroenterology faculty (from study start up to closure), as well as federally funded and industry-sponsored studies in the future. The CRCA will need to provide their own transportation with the ability to get to/from other off-site clinics. This position will be onsite and may require occasional evening and weekend hours. 
Duties include:<ul><li>
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.</li><li>
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.</li><li>
Coordinate collection of study specimens and processing.</li><li>
Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.</li><li>
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.</li><li>
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.</li><li>
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.</li><li>
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.</li><li>
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.</li><li>
Participate in monitor visits and regulatory audits.</li></ul><ul><li> 
- Other duties may also be assigned</li></ul>
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. 
Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $34.56 to $40.30 hourly.
<div>DESIRED QUALIFICATIONS: 
EDUCATION &amp; EXPERIENCE (REQUIRED): 
Two year college degree and two years related work experience or a Bachelor&rsquo;s degree in a related field or an equivalent combination of related education and relevant experience. 
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):<ul><li> Strong interpersonal skills.</li><li> Proficiency with Microsoft Office.</li><li> Knowledge of medical terminology.</li></ul> 
CERTIFICATIONS &amp; LICENSES: 
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 
PHYSICAL REQUIREMENTS*:<ul><li> 
 Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.</li><li> Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.</li><li> Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.</li></ul><ul><li> 
- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.</li></ul>
WORKING CONDITIONS:
Occasional evening and weekend hours.</div></div>

Clinical Research Coordinator Associate

St. Jude Children's Research Hospital

<div>Operates under general supervision. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data to the collaborating research organization or study sponsor. Prepares data reports.
Overview
The Department of Global Pediatric Medicine (GPM) is a growing department looking for professionals who are eager to help implement the St. Jude Global (SJG) mission by training the clinical workforce, developing and strengthening health systems and patient-centered initiatives, and advancing knowledge to sustain continuous improvement through research.
Responsibilities
The Global Clinical Research Associate I will be responsible for:<ul><li>
Supporting the Global Packages initiative which is a key component of the St. Jude Global Childhood Cancer Analytics Resource and Epidemiological Surveillance System (SJCARES) Adaptation Framework and Toolkit.</li><li>
Develop, maintain, monitor, and/or share assigned/relevant documentation (e.g., investigator files, case report forms, study data and reports).</li><li>
Maintain the Global Packages Master Protocols</li><li>
Support regulatory compliance for proper implementation of Global Packages globally</li><li>
Maintain/enter data as required for case report forms and assist with data processing, cleaning, and preparation to be done in preparation for aggregated or secondary analysis.</li><li>
Ensure compliance with prescribed interventions and evaluations of the assigned protocol(s).</li><li>
Provide data to the collaborating research organization (CRO) or study sponsor, and prepare data reports as directed.</li><li>
(As applicable) Provide education, coordination and data management (e.g., database access and queries; education on protocol activities).</li><li>
Perform other duties as assigned to meet the goals and objectives of the department and institution.</li><li>
Maintains regular and predictable attendance.</li></ul>
Skills and Abilities:<ul><li>
Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.</li><li>
Adapts quickly to changing priorities to perform as needed in his/her role.</li><li>
Remains calm when faced with changes to (and in) his/her work.</li><li>
Seeks clarifications to understand what is being said.</li><li>
Presents information in a clear, well thought out way and tailored to the audience.</li><li>
Is able to clearly summarize information learnt to confirm understanding.</li><li>
Writes in a clear and concise manner and speaks succinctly and confidently.</li><li>
Plans in advance, organizes own work, and executes high-quality work on time. Shows initiative to take on more responsibilities/work.</li><li>
Embraces goals and demonstrates a sense of urgency in achieving them.</li><li>
Holds self to high standards and keeps pushing to meet them.</li><li>
Supports clinical study and site management by performing basic tasks (operations/study management) under supervision.</li></ul>
All candidates must submit a cover letter to be considered for the position.
Minimum Education<ul><li>
Bachelor's degree in relevant area required.</li></ul>
Minimum Experience:<ul><li>
Minimum Requirement: Prior industry experience preferred.</li></ul>
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Clinical Research Associate I, Global Clinical Research.
Explore our exceptional benefits!<div>
St. Jude is an Equal Opportunity Employer</div>
No Search Firms
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.</div>

Clinical Research Associate I, Global Clinical Research

<div>
 Operates under general supervision. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data to the collaborating research organization or study sponsor. Prepares data reports.
 
 
 
 Overview
 
 
 
 The Department of Global Pediatric Medicine (GPM) is a growing department looking for professionals who are eager to help implement the St. Jude Global (SJG) mission by training the clinical workforce, developing and strengthening health systems and patient-centered initiatives, and advancing knowledge to sustain continuous improvement through research.
 
 
 
 Responsibilities
 
 
 
 The Global Clinical Research Associate I will be responsible for:
 
 
 <ul>
 <li>
 Supporting the Global Packages initiative which is a key component of the St. Jude Global Childhood Cancer Analytics Resource and Epidemiological Surveillance System (SJCARES) Adaptation Framework and Toolkit.
 </li>
 <li>
 Develop, maintain, monitor, and/or share assigned/relevant documentation (e.g., investigator files, case report forms, study data and reports).
 </li>
 <li>
 Maintain the Global Packages Master Protocols
 </li>
 <li>
 Support regulatory compliance for proper implementation of Global Packages globally
 </li>
 <li>
 Maintain/enter data as required for case report forms and assist with data processing, cleaning, and preparation to be done in preparation for aggregated or secondary analysis.
 </li>
 <li>
 Ensure compliance with prescribed interventions and evaluations of the assigned protocol(s).
 </li>
 <li>
 Provide data to the collaborating research organization (CRO) or study sponsor, and prepare data reports as directed.
 </li>
 <li>
 (As applicable) Provide education, coordination and data management (e.g., database access and queries; education on protocol activities).
 </li>
 <li>
 Perform other duties as assigned to meet the goals and objectives of the department and institution.
 </li>
 <li>
 Maintains regular and predictable attendance.
 
 
 
 </li>
 </ul>
 
 Skills and Abilities:
 
 
 
 <ul>
 <li>
 Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.
 </li>
 <li>
 Adapts quickly to changing priorities to perform as needed in his/her role.
 </li>
 <li>
 Remains calm when faced with changes to (and in) his/her work.
 </li>
 <li>
 Seeks clarifications to understand what is being said.
 </li>
 <li>
 Presents information in a clear, well thought out way and tailored to the audience.
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 Is able to clearly summarize information learnt to confirm understanding.
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 Writes in a clear and concise manner and speaks succinctly and confidently.
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 Plans in advance, organizes own work, and executes high-quality work on time. Shows initiative to take on more responsibilities/work.
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 Embraces goals and demonstrates a sense of urgency in achieving them.
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 Holds self to high standards and keeps pushing to meet them.
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 Supports clinical study and site management by performing basic tasks (operations/study management) under supervision.
 
 
 
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 All candidates must submit a cover letter to be considered for the position.
 
 
 
 
 Minimum Education
 
 
 
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 <li>
 Bachelor's degree in relevant area required.
 
 
 
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 </ul>
 
 Minimum Experience:
 
 
 
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 Minimum Requirement: Prior industry experience preferred.
 
 
 
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 </ul>
 
 Compensation
 
 
 
 In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Clinical Research Associate I, Global Clinical Research.
 
 
 Explore our exceptional benefits!
 
 
 St. Jude is an Equal Opportunity Employer
 
 
 
 No Search Firms
 
 
 
 St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
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