clinical research manager

Stanford University

<div><p>Stanford Cancer Institute &ndash; Clinical Trials Office &ndash; Clinical Research Manager &ndash; GI Oncology (Hybrid Work Schedule)</p><p>
The Stanford Cancer Institute (SCI) was re-designated as a comprehensive cancer center by the NCI in early 2022, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.</p><p>
We seek a Clinical Research Manager for GI Oncology to help us enact our mission to reduce cancer mortality through comprehensive cancer research, treatment, education, and outreach programs. Given the SCI&rsquo;s mission, breadth, and depth, we thrive in a fast-paced, team-oriented, and forward-thinking environment, employing over 375 staff with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral component of the SCI. This vital work enables our adult and pediatric cancer centers to translate research from the laboratory into clinical settings. You will be working with a world-class community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.</p><p>
Reporting to an Associate Director of Clinical Research, the Clinical Research Manager (CRM) GI Oncology will support cancer clinical research focused in oncology. The CRM will be conversant in the goals, mission, and priorities of the Institute and utilize this knowledge to conduct impactful clinical research focusing on high quality and efficiency. We are seeking candidates with excellent organizational skills, attention to detail, and a willingness to learn. Candidates must be eager to take on challenges with a high degree of professionalism, initiative, and flexibility. Responsibilities include working with the research team, clinical staff, and Stanford Health Care departments to support safe and compliant clinical research.</p><p><b>
Duties include*:</b></p><ul><li>
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.</li><li>
Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.</li><li>
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.</li><li>
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.</li><li>
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.</li><li>
Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.</li><li>
Lead or chair committees or task forces to address and resolve significant issues.</li><li>
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.</li><li>
Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.</li><li>
Assist with analysis of data and preparation of manuscripts and scientific presentations.</li><li><i>- Other duties may also be assigned.</i></li></ul>
<div><p><b>DESIRED QUALIFICATIONS:</b></p><ul><li>
Clinical research certification.</li><li>
Previous experience in oncology, specifically GI oncology.</li><li>
Experience with clinical trial finance management.</li></ul><p><b>
EDUCATION &amp; EXPERIENCE (REQUIRED):</b></p><p>
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred</p><p><b>
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):</b></p><ul><li>
Excellent interpersonal skills.</li><li>
Proficiency in Microsoft Office and database applications.</li><li>
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.</li><li>
Knowledge of medical terminology.</li><li>
Demonstrated managerial experience.</li></ul><p><b>
CERTIFICATIONS &amp; LICENSES:</b></p><p>
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.</p><p><b>
PHYSICAL REQUIREMENTS*:</b></p><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><li><i>- 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.</i></li></ul><br>
<b>
WORKING CONDITIONS:</b><ul><li>
Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.</li><li>
May require extended or unusual work hours based on research requirements and business needs.</li></ul><p><b>
WORK STANDARDS:</b></p><ul><li>
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.</li><li>
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.</li><li>
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.</li></ul><p><i><br>
The expected pay range for this position is $124,521 to $153,615 per annum.</i></p><p><i>
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.</i></p><p><i>
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (</i><i>https://cardinalatwork.stanford.edu/benefits-rewards</i><i>) provides detailed information on Stanford&rsquo;s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.</i></p><p><i>
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a </i><i>contact form</i><i>.</i></p><p><i>
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.</i></p><p><i>
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.</i></p></div></div>

Clinical Research Manager - GI Oncology (Hybrid)

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><div><p>
The Manager, Quality Assurance and Control (QA/QC Manager) will manage QA/QC clinical research study activities for the Texas Children's Cancer and Hematology Centers (TXCH) and the BCM Center for Cell and Gene Therapy (CAGT) to ensure compliance with all relevant local, federal, and state regulatory and institutional policies while identifying protocol problems, reviewing study-related documents, and ensuring that appropriate corrections are made and documented for missing or incomplete data. The QA/QC Manager will provide training and quality control (QC) evaluations for TXCH and CAGT clinical research staff, and will perform quality assurance (QA) audits of TXCH and CAGT clinical trials. The QA/QC Manager will review and update existing clinical research Standard Operating Procedures (SOPs) as well as develop new SOPs as needed, and provide associated training to the TXCH/CAGT clinical research staff.</p><p></p><p><br>
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.</p></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Sets study specific QA audit goals, plans audit activities, and performs a yearly assessment of compliance with meeting those goals.</li><li>
Monitors protocol compliance and documentation, performs clinical study conduct reviews, and verifies clinical research staff competencies. This includes review of investigator-initiated, group sponsored, industry sponsored, multi-site, treatment and non-treatment studies administered by TXCH and CAGT.</li><li>
Prepares QA audit and QC review reports for principal investigators (PIs) and clinical research teams to effectively communicate findings, and works with senior TXCH and CAGT leadership to provide suitable recommendations for corrective actions.</li><li>
Presents QA audit and QC review reports along with annual assessments of QA/QC activity to the TXCH/CAGT Clinical Research Oversight Committee (CROC) at monthly meetings.</li><li>
Presides over QA audits and QC reviews, and assists study staff in preparing for outside audit/monitoring visits and collection of delinquent data.</li><li>
Performs training and evaluation of TXCH/CAGT clinical research staff (research nurses, research coordinators, data managers, and regulatory coordinators) with regard to adherence to relevant clinical research operations and SOPs.</li><li>
Manages primarily professional level junior and senior QA/QC staff, to include defining work responsibilities and prioritization, setting performance development plans and goals, and conducting annual performance evaluations.</li><li>
Performs other job related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree.</li><li>
Four years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Department Specific Criteria</b></h2></div><div><ul><li>
Knowledge of clinical research operations, medical terminology, and anatomy required</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
B.S. or B.A. in science or health related field</li><li>
CCRA, CCRP, or CCRC</li><li>
Prior oncology clinical research QA/QC experience</li></ul></div></div></div><p></p><p><b><br>
Work Authorization Requirement:</b></p><p><b>
This position is not eligible for visa sponsorship.</b> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.</p><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div>

Manager, Quality Assurance and Control - Clinical Research

University of Florida

<p></p><div><div><p><b>JOB NO:</b></p>
<div>538035</div><br>
<p><b>WORK TYPE:</b></p>
<div>Staff Full-Time</div><br>
<p><b>LOCATION:</b></p>
<div>Main Campus (Gainesville, FL)</div><br>
<p><b>CATEGORIES:</b></p>
<div>Health Care Administration/Support</div><br>
<p><b>DEPARTMENT:</b></p><div>
29050800 - MD-INFECTIOUS DISEASES</div></div><br>
<div>
<div><div><div><div><b>CLASSIFICATION TITLE:</b></div>
<div>
<p>Manager, Clinical Research</p></div><br>
</div><br>
<div><div><b>JOB DESCRIPTION:</b></div>
<div>
<p>Under the direction of the Assistant Director, the Manager, Clinical Research will be responsible for providing management and direction of the division&rsquo;s clinical and human subject research portfolio. This position will be responsible for managing all budgetary and fiscal matters related to clinical trials, including negotiating clinical trial budgets and payment terms with industry sponsors, managing all post award financials, invoices, and reconciliations. This position will oversee the team of coordinators to ensure they have all necessary resources to perform their jobs effectively and efficiently.</p>
<div><b>
Pre-Award Clinical Trial Management</b><br>
<ul><li>Lead clinical trial negotiations with industry sponsors, with support from the Principal Investigator and Assistant Director and assistance from clinical research coordinators.</li><li>Oversee the preparation of IRB applications and maintain regulatory and IRB approvals throughout the project lifecycle and serve as a resource for the clinical research coordinators during their completion of the IRB process</li><li>Prepare financial analysis for proposed clinical trials to ensure financial viability of study based on enrollment projections</li><li>Review clinical research protocols to assess feasibility and serve as a resource, providing guidance, to study coordinators with planning and implementing strategies for successful participant recruitment.</li><li>Managing all clinical trial workflow through UFIRST</li></ul><br>
<b>
Post Award Clinical Trial Management</b><br>
<ul><li>Maintain accurate accounts receivable and payable data</li><li>Invoice sponsors for services rendered</li><li>Reconcile all electronic study payments via the university&rsquo;s clinical research system</li><li>Prepare monthly reports outlining financial status of studies, enrollment target, etc. and present to PI and Assistant Director</li><li>Facilitate timely reconciliation and close-out of terminated clinical trial accounts</li><li>Maintain, oversee, reconcile, and correct errors in accounts. Process clinical research and core bills for payment</li><li>Partner with Clinical Trial team on budgetary amendment implementation</li><li>Manage clinical study financial closeout and residual balance transfers</li><li>Oversee updates to documentation in response to IRB or Regulatory comments and queries, ensuring all regulatory documents are current and compliant, in conjunction with the clinical research coordinators</li><li>Oversee the preparation and collation of all documentation required to support clinical trial applications, ensuring compliance with regulatory standards.</li><li>Direct the development and review of briefing documents to facilitate effective meetings with regulatory bodies</li><li>Coordinate the preparation and submission of annual reports, ensuring timely and accurate documentation.</li><li>Implement and maintain a comprehensive document filing system for easy access and historical tracking of documentation across projects</li><li>Supervise the renewal, re-registration, and submission of variations, amendments, and notifications, maintaining up-to-date regulatory status reports for all active projects</li></ul><br>
<b>
Team Management</b><br>
<ul><li>Function independently and proactively with strong critical thinking, analytical, and communication skills</li><li>Support the Chief, Faculty, and Division Administrator in advancing the research missions of the Division of Infectious Diseases and Global Medicine.
</li><li>Collaborate closely with clinical research coordinators, the grants team, the Division Administrator, and the University&rsquo;s clinical research hub to oversee the division&rsquo;s clinical research activities.</li><li>Provide training and support to divisional clinical research coordinators and serve as a clinical research coordinator for select clinical trials.</li><li>Step in as a study coordinator as needed to support ongoing clinical trials and ensure continuity of research activities.</li><li>Oversee the clinical research team staffing, working closely with clinical research coordinator 3&rsquo;s to ensure the team is sufficiently and appropriately staffed</li></ul><b>
Other</b><br>
<ul><li>Assist the Division Administrator with ad hoc assignments to support basic science research faculty and laboratories.</li><li>Prepare annual budget information to include in the division&rsquo;s annual budget.</li><li>Manage the division&rsquo;s clinical trials operating account, including preparing annual projections for daily management and future staffing purposes.</li></ul></div></div><br>
</div><br>
<div><div><b>EXPECTED SALARY:</b></div>
<div>
<p>$82,000 - 92,200 annually</p></div><br>
</div><br>
<div><div><b>REQUIRED QUALIFICATIONS:</b></div>
<div>
<div><p>Master&rsquo;s degree in appropriate area of specialization; or a bachelor&rsquo;s degree in appropriate areas of specialization and two years of experience.</p></div><br>
</div>
</div><br>
<div><div><b>PREFERRED:</b></div>
<div>
<div><p>Prior experience negotiating clinical trials with industry sponsors.<br>
Familiarity with regulatory documentation and clinical trials.<br>
Prior clinical trial coordinator experience.<br>
Strong communication skills, good organization, detail oriented, familiarity with medical environment.</p></div><br>
</div>
</div><br>
<div><div><b>SPECIAL INSTRUCTIONS TO APPLICANTS:</b></div>
<div>
<p>In order to be considered, you must upload your cover letter and resume.</p>
<p>
Application must be submitted by 11:55 p.m. (ET) of the posting end date.</p></div><br>
</div><br>
<div><div><b>HEALTH ASSESSMENT REQUIRED:</b></div> <div>Yes</div></div></div><br>
</div>
</div><p></p><div><p><b>ADVERTISED:</b></p>
<div>03 Dec 2025</div> Eastern Standard Time<br>
<p><b>APPLICATIONS CLOSE:</b></p>
<div><div>17 Dec 2025</div></div>
Eastern Standard Time</div></div><p></p>

MGR, Clinical Research

Clinilabs

<div>Description:
<p><b>
JOB SUMMARY</b></p><p>
The Clinical Research Quality Control Manager is a senior leader responsible for the strategic oversight, planning, and execution of all quality control activities within the clinical research unit. This role ensures that clinical trial processes, documentation, and regulatory submissions consistently meet internal standards and external regulatory requirements. The manager leads QC reviews, identifies non-conformances, drives process improvements, and mentors QC staff.</p><p></p><p><b><br>
RESPONSIBILITIES</b></p><p><i>
Strategic Leadership &amp; Oversight</i></p><ul><li>
Develop, implement, and maintain a comprehensive quality control program for clinical research activities.</li><li>
Lead and mentor QC staff, providing guidance, training, and performance management.</li><li>
Serve as the subject matter expert for QC processes, regulations, and best practices.</li></ul><p><i>
Quality Control Operations</i></p><ul><li>
Oversee QC review of clinical documents (source documentation, regulatory binder, pharmacy binder, laboratory binder, presentation materials, and clinical sections of regulatory submissions).</li><li>
Ensure all clinical processes comply with applicable regulations, SOPs, laboratory manuals, and study protocols.</li><li>
Oversee alignment of processing forms and shipping manifests with SOPs and protocols.</li><li>
Attend key study visits to ensure quality and compliance.</li><li>
Follow up on outstanding source documentation review issues with designated staff.</li><li>
Maintain and utilize QC tracking logs for live QC activities.</li></ul><p><i>
Continuous Improvement &amp; Risk Mitigation</i></p><ul><li>
Identify non-conformances during clinical trial conduct and lead root cause analyses.</li><li>
Develop and implement risk mitigation strategies and corrective action plans.</li><li>
Drive ongoing process improvement initiatives.</li></ul><p><i>
Training &amp; SOP Development</i></p><ul><li>
Lead the writing and review of clinical quality-related SOPs.</li></ul><p><i>
Regulatory &amp; Compliance</i></p><ul><li>
Ensure correct IRB-approved informed consent forms and subject source documents are used.</li><li>
Communicate with operational departments regarding project status and issues.</li><li>
Ensure compliance with current Good Clinical Practices (cGCPs) and corporate policies.</li></ul><p><i>
Strategic Planning &amp; Vision</i></p><ul><li>
Develop and execute the long-term vision and strategy for quality control across all clinical research programs.</li><li>
Align QC objectives with organizational goals and regulatory trends.</li></ul><p><i>
Organizational Leadership</i></p><ul><li>
Lead and manage multiple QC teams or units across sites, ensuring consistency and excellence in QC practices.</li><li>
Oversee recruitment, development, and retention of QC staff; set performance standards and conduct evaluations.</li></ul><p><i>
Cross-Functional Collaboration</i></p><ul><li>
Serve as the primary QC liaison to executive leadership, regulatory affairs, clinical operations, and external partners.</li><li>
Lead cross-functional committees focused on quality, compliance, and process improvement.</li></ul><p><i>
Other Duties</i></p><ul><li>
Perform other QC-related duties as assigned.</li></ul><p><b>
TRAVELING</b></p><p>
Between Corporate New Jersey and New York locations, as needed.</p><p>
Salary Range: $85,000&ndash;$95,000 annually. Final compensation is based on skills, experience, location, and overall expertise.</p>
Requirements:
<ul><li>Education: Bachelor&rsquo;s degree in a relevant field (e.g., Life Sciences, Chemistry, Biology, Nursing, or related discipline) required; advanced degree preferred.</li><li>
Experience: Minimum 5 years of progressive experience in clinical research quality control or related field, with at least 2 years in a leadership or management role.</li><li>
Deep knowledge of clinical research processes, regulatory requirements, and QC methodologies.</li><li>
Proven leadership and team management abilities.</li><li>
Excellent communication, analytical, and problem-solving skills.</li><li>
Strong organizational and project management skills.</li><li>
Ability to provide accurate documentation and drive process improvements.</li></ul></div>

Manager, Clinical Research Quality Control

Stryker

<div><h3 class="jobSectionHeader"><b>Why join Stryker?</b></h3>
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.<br>
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards &ndash; not to mention various social and recreational activities, all of which are location specific.<h3 class="jobSectionHeader"><b>
Job description</b></h3>
We are excited to be named one of the World&rsquo;s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.<div><p><b>
Senior Clinical Study Manager (Remote)
</b></p><p></p><p>Stryker is hiring a Senior Clinical Study Manager to support our Medical Division. In this role you will be responsible for executing the clinical evidence strategy for medical devices, and support the development of this strategy, to enable new and continued global market access.</p><p></p><p><b>
Work Flexibility: </b>Remote - <i>Preferred location is the Midwest or Eastern United States</i></p><p></p><p><b>
What you will do</b></p><ul><li>
Manage day-to-day operations of one or more clinical studies, ensuring compliance with GCP, FDA regulations, and internal procedures.</li><li>
Develop and maintain study-specific documents, including protocols, amendments, monitoring plans, and operational guidelines.</li><li>
Oversee data collection, validation, and documentation to meet quality standards and timelines.</li><li>
Coordinate and support field-monitoring activities; track enrollment curves and study milestones.</li><li>
Assess project risks and implement mitigation strategies to ensure deliverables are achieved.</li><li>
Initiate and manage research contracts for Investigator-Initiated Studies and ensure alignment with research strategy.</li><li>
Drive publication of study results in peer-reviewed journals by collaborating with internal and external stakeholders.</li><li>
Maintain dashboards for clinical and non-clinical studies, tracking objectives, timelines, and financial aspects.</li><li>
Oversees clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).</li><li>
Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence.</li></ul><p></p><p><b>
What you need</b></p><p>
Basic Qualifications:</p><ul><li>
Bachelor&rsquo;s degree, preferably with Health Sciences or related technical field.</li><li>
6+ years of relevant clinical research experience, preferred in clinical study management.</li></ul><p>
Preferred Qualifications:</p><ul><li>
Medical device experience.</li><li>
Advanced degree (MSc, PhD) in health sciences, biomedical engineering, health outcomes research.</li><li>
Preferred clinical research or project management certification</li></ul><p></p><p>
$100,500.00 - $215,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.</p><p><br>
This role will be posted for a minimum of 3 days.</p></div>
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&amp;D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.</div>

Senior Clinical Study Manager (Remote)

University of Miami

<div><p><b>Current Employees:
</b></p><p>If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet .
</p><p></p><p>The UHealth System at the University of Miami has an exciting opportunity for a Clinical Research Coordinator 3 in the Radiation Oncology Department
</p><p></p><p><b>CORE JOB SUMMARY
</b><br>
The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies&rsquo; daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study&rsquo;s integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.
<br>
<br>
<b>CORE JOB FUNCTIONS
</b><br>
1. Coordinates the implementation of multiple complex clinical research protocols.
<br>
2. Develops SOPs and templates with guidance from the PI/Clinical Research Manager.
<br>
3. Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
<br>
4. Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.
<br>
5. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.
<br>
6. Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.
<br>
7. Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
<br>
8. Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.
<br>
9. Organizes/manages site visits and internal/external auditing activities as assigned.
<br>
10. Coordinates research team meetings; assures communications across-the-board.
<br>
11. Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.
<br>
12. Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.
<br>
13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
<br>
14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
<br>
15. Adheres to University and unit-level policies and procedures and safeguards University assets.
<br>
<br>
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
<br>
<br>
<b>CORE QUALIFICATIONS
</b><br>
<b>Education:
</b><br>
Bachelor&rsquo;s degree in relevant field required
<br>
<b>Experience:
</b><br>
Minimum 4 years of relevant experience required
<br>
<b>Knowledge, Skills and Abilities </b>:
</p><p></p><ul><li><p>Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
</p></li><li><p>Teamwork: Ability to work collaboratively with others and contribute to a team environment.
</p></li><li><p>Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
</p></li><li><p>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.<br>
</p></li></ul><p></p><p><br>
<i>This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.
</i></p><p></p><p>The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
</p><p></p><p>UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
</p><p></p><p>The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
</p><p></p><p><b>Job Status:
</b></p>Full time
<p></p><p><b>Employee Type:
</b></p>Staff</div>

Clinical Research Coordinator

Tufts Medical Center

<div><p><b>Job Profile Summary</b></p><p>
This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Administration duties: Supports the administration of research practices working to achieve the organization's practices goals, plans, priorities, and tracks investments, allocates resources and makes decision regarding research administrative activities. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An experienced level role that applies practical knowledge of job area typically obtained through advanced education and work experience. Works independently with general supervision, problems faced are difficult but typically not complex, and may influence others within the job area through explanation of facts, policies and practices.</p><p></p><p><b>
Job Overview</b></p><p>
This position supports clinical investigators, research administrators, clinical trials, and study teams across the organization. Primary responsibilities include assisting with development, negotiation, approval of clinical research budgets and financial terms, and management of study financials through the lifecycle of the study. As a level II specialist, will either participate as a team member or serve on a committee for special projects in Research Administration.</p><p></p><p><b><br>
Job Description</b></p><p><b>
Minimum Qualifications:</b></p><p>
1. Bachelor&rsquo;s degree in Healthcare Administration or related field.</p><p>
2. Three (3) years' experience in clinical trials research or research administration</p><p></p><p><b><br>
Preferred Qualifications:</b></p><p>
1. Experience in the following areas of clinical research: budgeting, project management, compliance, regulatory management, and/or medical billing.</p><p>
2. Five (5) years of experience.</p><p></p><p><b><br>
Duties and Responsibilities:</b> The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.</p><p></p><p><br>
1. Assists clinical investigators, research administrators, and/or study teams in development, negotiation, and approval of clinical research budgets in accordance with policies.
</p><p>2. With support from their manager, reviews clinical research protocols for resource and financial implications and develops accurate budgets.
</p><p>3. Assists with preparing financial analyses on device trials, as necessary, and serves as a resource to investigators on device regulations.
</p><p>4. Helps with developing Medicare Coverage Analyses for all studies, distinguishing between billable and non-billable costs and ensures overall adherence to Federal Compliance in the budgeting process.</p><p>
5. Meets collaboratively with research personnel to identify and quantify information impacting clinical trial finances.
</p><p>6. Serves as one of several resources on the business aspects of clinical research and maintains appropriate records and databases.
</p><p>7. With the support from their manager, advises principal investigators, researchers, and staff in the compliant clinical, regulatory, and fiscal conduct of all projects.</p><p>
8. Communicates in writing and verbally with investigators, study coordinators, research administrators, sponsors and others within the clinical research infrastructure about clinical research financial services.</p><p>
9. Monitors and tracks monthly study expenses, ancillary billing, personnel costs.
</p><p>10. Track study milestones, payments, and study invoicing.
</p><p>11. Complete study reconciliation monthly and at the close of study against payments received, milestones, and invoices.
</p><p>12. Assist with performance metrics and financial analysis.</p><p>
13. Participates as a team member or may serve on committees for special projects in Research Administration.</p><p></p><p><b><br>
Physical Requirements:</b></p><p>
1. Frequent and continuous typing/computer keying, telephone use, and sitting for extended periods.</p><p></p><p><b><br>
Skills &amp; Abilities:</b></p><p>
1. Expertise in project management.</p><p>
2. Excellent interpersonal skills to deal effectively with researchers, staff, administrators and customers.
</p><p>3. Excellent organizational skills to manage workflow independently.
</p><p>4. Ability to multitask.</p><p>
5. Requires meticulous attention to detail with excellent data management and organizational skills.</p><p>
6. Strong interpersonal skills.</p><p>
7. Strong written and verbal communication skills.</p><p>
8. Ability to operate effectively in a fast-paced constantly changing environment.</p><p>
9. Competency in Microsoft Office.</p><p>
10. Outstanding customer service skills.</p><p>
11. Ability to prioritize quickly and appropriately.</p><p></p><p><br>
At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.</p><p></p><p>
The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.</p><p></p><p>
Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth&mdash;one of the many ways we invest in you so you can thrive both at work and outside of it.</p><p></p><p><b><br>
Pay Range</b><b>:</b></p></div><p></p>

Clinical Research Budget & Financial Specialist - Clinical Trials Office

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