clinical research director

Medtronic

<div>We anticipate the application window for this opening will close on - 21 Mar 2026<br>
<p></p><br>
<p>At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
</p><p></p><h1 class="jobSectionHeader"><b>A Day in the Life
</b></h1>The Sr Clinical Research Director, Cardiac Ablations Solutions (CAS) reports directly to the Chief Medical Officer, CAS. This position is responsible for directing all global clinical research activities and programs to generate clinical and economic evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business and R&amp;D strategies for the Cardiac Ablation Solutions Operating Unit. The leader is also responsible for designing and driving the execution of pre-market and post-market clinical trials globally, including driving outcomes and results, and collaborating for the dissemination of the resulting evidence to internal and external stakeholders. The goal of these programs is to develop the medical evidence necessary to demonstrate safety, efficacy, economic and quality of life outcomes for the performance of our products and therapies. Programs will support global regulatory approval, reimbursement coverage through comparative effectiveness evidence, therapy adoption and new indications. The CAS Clinical Leader helps set the strategy and manages/approves funding for external physician-initiated research programs (ERP) on a global basis. In addition, the leader will collaborate closely with the Economic Evidence team to provide additional value to the business.
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Ideally candidate would be based on the Minneapolis, MN area - but will consider remote.
<p></p><ul><li>Lead global strategic clinical plan process, investment prioritization efforts, and area reviews. Create the global strategic clinical plan and lead the development of regional clinical strategies.
</li><li>Lead the process to define the key stakeholder needs (including but not limited to customer, regulatory agency and payer requirements) for medical evidence for the safety, efficacy, and economic outcomes necessary to establish our therapies as the standard of care.
</li><li>Provide strategic leadership to evidence generation activities including design of Clinical trials retrospective database analysis, meta-analysis, translation of clinical data to marketing messages and other health service research endeavors.
</li><li>Have a working knowledge of patient reported outcomes instruments, and development of value messages to satisfy stakeholder needs.
</li><li>Set the strategy and manage/approve funding for external physician-initiated research programs (ERP).
</li><li>Develop and maintain an extensive physician network globally to understand customer needs and convey the evidence supporting the preferential use of our products and therapies.
</li><li>Play a leading role in the development of evidence to support clinically and economically differentiated products for specific (emerging and developed) markets. Ensure that clinical trial design is aimed at fulfilling the common and unique needs of different geographies.
</li><li>Successfully create, initiate, and conduct studies consistent with the clinical strategy and business unit objectives. In collaboration with the clinical research organization this includes Clinical Investigation Protocol (CIP) creation, budget drafting and management, trial execution, publication and evidence dissemination.
</li><li>Direct trial concept assessment and creation with functional leaders&rsquo; support
</li><li>Ensure effectiveness of CAS global clinical activities through strong collaboration and communication with Geography, Clinical Function, Marketing, Research, Technology, Product Development and Operating Unit leadership regarding clinical research and link to the overall business strategy.
</li><li>Take primary accountability for clinical trial execution.
</li><li>Interact directly with senior leaders and executives to bring awareness and achieve resolution of significant issues concerning products and therapies detected during clinical trials.
</li><li>Collaborate with Regulatory, Reimbursement, Healthcare Economics, and Marketing to develop and execute plans to utilize the results of clinical trials to advance business objectives.
</li><li>Work cross-functionally and with external advisors, consultants and investigators to direct publication plans to ensure dissemination of clinical and economic evidence through manuscripts, society meetings presentations, payer presentations, etc.
</li><li>Interface with representatives from key functional groups including field clinical and technical staff, Product Development, Marketing, Sales, Regulatory Affairs and Quality and local governing bodies.
</li><li>Ensure the publishing of results and collaboration with physicians to make known the outcomes of studies and corresponding medical advancements.
</li><li>Represent the CAS OU on matters related to clinical evaluation of CAS Business products and therapies internally and externally.
</li><li>Represent CAS business clinical research internationally and build deeper local market knowledge and connections regarding products and strategies. Support global product launches, training, and customer support plans. Collaborate with geography clinical and business leads to create local clinical strategies.
</li><li>Collaborate with Business Development in the identification, early evaluation, and due diligence of opportunities for investment or acquisition.
</li><li>Manage expenses within budget, maximizing effectiveness and efficiency.
</li><li>Work within and actively promote Medtronic&rsquo;s core mission, corporate strategies, policies, procedures and Code of Conduct.
</li></ul><p><b>QUALIFICATIONS SECTION<br>
</b><br>
</p><p>Must Have: Minimum Requirements
</p><ul><li>Advanced degree (Ph.D., PharmD, or MBA)
</li><li>15+ years of experience in clinical research in the medical device industry with IDE and PMA submission experience
</li><li>10+ years of progressive managerial experience in clinical research
</li></ul><p></p><p>Nice to Have
</p><p></p><ul><li>Deep EP knowledge (highly preferred)
</li><li>Demonstrated ability to work with FDA and other global regulatory agencies and bodies
</li><li>Work experience directly in a strategic clinical or marketing role
</li><li>Demonstrated ability of research skills for study design and analysis
</li><li>Demonstrated knowledge of Data Management and Clinical trial processes
</li><li>Understanding of dynamic clinical research environment, including global regulations and policies
</li><li>Strong interpersonal skills and ability to collaborate with and influence physicians, nurses, and regulators.
</li><li>Demonstrated ability to work with organizational decision makers &ndash; Executives, R&amp;D, Marketing, Regulatory, etc.
</li><li>Ability to maintain proactive relationship with R&amp;D, Marketing and Regulatory within CRM and Medtronic
</li><li>Demonstrated use of business and financial measures
</li>Excellent communication and presentation skills <li>- written and verbal
</li><li>Demonstrating ability to negotiate and utilize effective influencing and sales skills
</li></ul><p></p><p><b>Physical Job Requirements
</b></p><p></p><p>The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
</p><p></p><p>The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
</p><p></p><h1 class="jobSectionHeader"><b>Benefits &amp; Compensation<br>
</b><br>
</h1><p><b>Medtronic offers a competitive Salary and flexible Benefits Package
</b><br>
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.<br>
<br>
</p><p></p>Salary ranges for U.S (excl. PR) locations (USD):$266,400.00 - $399,600.00<br>
<p></p>This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
<p></p>This position is eligible for an annual long-term incentive plan.
<p></p>The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
<p></p><p>The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).<br>
</p><p></p><p>The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).<br>
</p><p></p><p>Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.<br>
</p><p></p><p>Further details are available at the link below:</p><p>
</p><p></p><h1 class="jobSectionHeader"><b>About Medtronic
</b></h1><p>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
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Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
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We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.</p><p></p><p><br>
</p><p></p><p>It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
</p><p></p><div><div><div><div><div><div><div><p>If you are applying to perform work for Medtronic, Inc. (&ldquo;Medtronic&rdquo;) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.</p></div></div></div></div></div></div></div></div>

Global Sr Clinical Research Director, Cardiac Ablation Solutions

Cancer Specialists of North Florida

<div><p><b><i>Cancer Specialists of North Florida</i></b> is recruiting for an experienced <b><i>Research Business Program Manager</i></b> for our busy <b><i>Research Department.</i></b> The Research Business Program Manager will be responsible for executing key deliverables by utilizing innovative tactics, processes, tools, systems, and strategies to ensure research program efficiency, quality, and compliance is maintained. The Research Business Program Manager will work closely with the Clinical Research Director and Clinical Research Manager on process improvement and quality assurance, training of department staff, and adherence to clinical trial protocols. The Research Program Manager will also assist with research billing activities to ensure adherence to clinical trial budgets and contracts. Essential duties and responsibilities include the following:</p><p><b>
Operational Management &amp; Execution</b></p><ul><li>
Work closely with the Director of Clinical Research to standardize and optimize research operations across all trials, ensuring consistent execution, reduced variability, and scalable workflows as the portfolio grows.</li><li>
Proactively identify operational inefficiencies, performance gaps, and compliance risks; design, implement, and sustain process improvements that measurably improve startup timelines, enrollment throughput, and data quality.</li><li>
Develop, maintain, and continuously refine enterprise-level tracking systems that provide real-time visibility into:<ul><li>
Trial enrollment and accrual performance</li><li>
Physician participation and engagement trends</li><li>
Research staff workload, capacity, and utilization</li></ul></li><li>
Establish and enforce quality benchmarks and operational standards that align with GCP, sponsor expectations, and organizational performance goals.</li></ul><p><b>
Quality Assurance, Compliance &amp; Audit Readiness</b></p><ul><li>
Own the development and maintenance of QA-focused Standard Operating Procedures (SOPs), ensuring they are current, practical, and embedded into daily operations.</li><li>
Ensure all research activities are always inspection-ready, with clear documentation, traceability, and staff accountability.</li><li>
Serve as the operational lead for addressing audit and monitoring findings, maintaining continuous communication with leadership, staff, and external stakeholders until closure.</li></ul><p><b>
Financial &amp; Billing Alignment</b></p><ul><li>
Partner with the billing and finance teams to ensure accurate, timely, and compliant research billing, minimizing financial risk and revenue leakage.</li><li>
Oversee research operational processes related to administrative and patient milestone tracking</li><li>
Identify and escalate billing or cost-related risks early, ensuring alignment between study budgets, services rendered, and revenue capture.</li><li>
Support leadership with transparent, auditable documentation related to research billing and cost accountability.</li></ul><p><b>
Team Leadership &amp; Staff Enablement</b></p><ul><li>
Serve as the primary operational authority for research staff regarding trial documentation standards, data integrity expectations, and system use.</li><li>
Ensure timely and accurate data entry, query resolution, and monitoring readiness across all studies.</li><li>
Establish clear expectations, tools, and accountability structures that enable staff to meet performance and quality benchmarks.</li><li>
Support onboarding, training, and ongoing competency development for data and QA-focused team members, ensuring consistent execution regardless of study complexity.</li><li>
Act as a stabilizing operational presence, reducing rework, confusion, and staff burnout through clarity and structure.</li></ul><p><b>
Study Start-Up, Systems &amp; Documentation</b></p><ul><li>
Own the development and maintenance of EMR-integrated research workflows, ensuring study-specific order sets, care plans, and documentation are accurate, standardized, and provider-friendly.</li><li>
Ensure consistency and integrity of source documentation standards across trials, providers, and staff.</li><li>
Support study start-up activities by validating operational readiness, documentation completeness, and system integration prior to activation.</li><li>
Partner in clinical trial budget review to identify operational or documentation risks that could impact billing, compliance, or execution.</li></ul><p>
Full-time Position, Monday &ndash; Friday</p><p><b>
Location:</b> 7751 Belfort Parkway, Jacksonville, FL 32256</p><p><b>
Education and Experience:</b></p><ul><li>
Bachelor&rsquo;s degree and 4+ years of experience in working with complex clinical trials from a site, sponsor, or CRO perspective with a preferred focus on oncology and/or hematology</li><li>
2+ years project and/or vendor management experience</li><li>
Data Quality Assurance (QA)/auditing experience is a plus</li></ul><p><b>
Certificates, Licenses, Registrations:</b></p><ul><li>
CCRP, preferred</li></ul><p><b>
Compensation and Benefits:</b></p><ul><li>
Salary is commensurate with experience and qualifications</li></ul><p>
Cancer Specialists of North Florida is an &quot;EEO Employer&rdquo; and &ldquo;Drug Free Workplace&rdquo;</p></div><p></p>

Research Business Program Manager

Rockefeller University

<div>Organization Overview: The new Diagnostic and Treatment Center (D&amp;TC) will be named the &ldquo;Rockefeller University Clinical Research Center&rdquo; (RCRC). The University remains committed to its mission of improving the understanding of science for the benefit of humanity through both clinical and basic research in a diverse range of biological and biomedical issues. The outpatient D&amp;TC reflects the evolution in clinical research to outpatient studies. Overview:
<div>
Reporting to the Executive Director, the Clinical Research Officer (CRO) leads participant-focused research practices and is responsible for developing, implementing, and evaluating strategies to enhance participant engagement, equitable recruitment, high-quality informed consent, and the overall research experience within an outpatient diagnostic and treatment environment.</div><div></div><div><br>
Working in close partnership with medical, regulatory, and operational leadership, the CRO ensures that participant-centered principles are meaningfully integrated into the design and conduct of clinical research. The CRO also serves as a senior advisor on the design and implementation of clinical research protocols at the Diagnostic and Treatment Center (D&amp;TC).</div>
Responsibilities:
<div>
The Clinical Research Officer shapes and advances participant-focused research practices through strategic leadership and supervision of participant engagement initiatives. The CRO enhances recruitment effectiveness, participant experience, ethical rigor, and equitable access to research participation. The role strengthens institutional research quality by ensuring participant-centered principles are embedded in the operational and strategic framework of the D&amp;TC.</div><div></div><div><br>
Position duties and responsibilities include, but are not limited to, the following:</div><ul><li><div>
Develops and leads the implementation of participant-focused research practices.</div></li><li><div>
Establishes best practices to enhance informed consent processes, participant communication, recruitment approaches, and research experience standards.</div></li><li><div>
Integrates participant-centered principles into outpatient clinical research workflows and operational procedures.</div></li><li><div>
Oversees development and evaluation of participant experience metrics and quality improvement initiatives. Directs recruitment strategy development in collaboration with investigators and clinical operations.</div></li><li><div>
Promotes equitable access to research participation and supports inclusive recruitment practices.</div></li><li><div>
Provides oversight and guidance to the Participant Engagement and Recruitment Specialist. Advises investigators and leadership on participant-centered considerations in clinical trial design and implementation within a Diagnostic and Treatment Center model.</div></li><li><div>
Assesses protocol feasibility related to recruitment, retention, and participant burden. Translates participant feedback and operational insights into continuous improvements in research processes.</div></li><li><div>
Partners with medical, regulatory, and operational leadership to ensure alignment with Good Clinical Practice (GCP), FDA, IRB, NIH, and institutional standards related to participant protection.</div></li><li><div>
Strengthens institutional practices related to informed consent quality, confidentiality, and ethical conduct of research. Contributes to audit-readiness and continuous compliance improvement efforts.</div></li><li><div>
Other duties and special projects as assigned.</div></li></ul>
Qualifications:
<div><b>
REQUIRED QUALIFICATIONS:</b></div><ul><li>
A bachelor&rsquo;s degree in life sciences, health sciences, nursing, medicine, pharmacology, or a related field is required.</li><li>
Minimum of five (5) years of research experience in clinical or translational research, including significant experience in human subjects research.</li><li>
Position requires in-person, onsite presence.</li><li>
Demonstrated ability to supervise research compliance initiatives and implement participant-focused research practices.</li><li><div>
Prior experience advising on clinical trial design and operational implementation in regulated research environments. Strong knowledge of Good Clinical Practice (GCP), FDA, and IRB regulations. Ability to integrate participant-centered initiatives into operational research workflows.</div></li><li><div>
Familiarity with ethical standards in human research (informed consent, confidentiality). Ability to navigate challenges and make informed, ethical decisions.</div></li><li><div>
Must have a passion for excellent customer service and commitment to exceptional quality. Strong interpersonal, written, and oral communication skills, along with attention to detail, are essential. Initiative and self-motivation are critical.</div></li></ul><div></div><div><b><br>
PREFERRED QUALIFICATIONS:</b></div><ul><li>
Advanced degree preferred.</li><li>
Advanced methodological expertise in clinical trial design and implementation.</li><li>
Prior experience in an academic or research institution is strongly preferred.</li></ul><div><br>
The Rockefeller University is an equal opportunity employer &ndash; veterans/individuals with disabilities. Qualified applicants will receive consideration for employment without regard to characteristics protected by applicable local, state, or federal law, including but not limited to disability and protected veteran status.</div><div></div><div><br>
The salary of the finalist selected for this role will be set based on various factors, including but not limited to organizational budgets, qualifications, experience, education, licenses, specialty, and training. The hiring range provided represents The Rockefeller University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div>
Compensation Range: Min: USD $130,000.00/Yr. Compensation Range: Max: USD $150,000.00/Yr.</div>

Clinical Research Officer | Diagnostic & Treatment Center

Calico Life Sciences

<div><h4 class="jobSectionHeader"><b>Who We Are:</b></h4>
<p>
Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico&rsquo;s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.</p>
<p><b>
Position Description:</b></p>
<p>
The Associate Director, Clinical Scientist at Calico is responsible for the planning and execution of the translational and clinical development plans and protocols for several projects across therapeutic areas, related to Calico&rsquo;s mission to improve human healthspan by understanding aging and age-related diseases. The successful candidate will participate in and drive the development of clinical strategies for assigned program(s)/indication(s) and should be able to support novel and innovative clinical plans while ensuring a positive and collaborative team environment.</p>
<p><b>
Responsibilities:</b></p>
<ul>
<li>In coordination with the Head of Clinical Science and/or Medical Director(s), leads or represents the Clinical Science function in cross-functional project and study teams that develop and execute the clinical development plan to translate preclinical mechanistic data to humans for novel aging-related targets</li>
<li>Authors clinical sections of assigned protocols from Phase 0 through Phase 2, collaborating with other functions required for protocol development, including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing</li>
<li>Contributes to the design and execution of experimental medicine studies to demonstrate proof-of-mechanism of novel targets in aging and age-related diseases</li>
<li>Interfaces with academic investigators to assist in execution of Investigator initiated trials</li>
<li>Contributes to and/or reviews relevant study documents including Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, Operations/Technical Manuals, IND/CTAs, case report forms and data tables, listings and figures, CSRs</li>
<li>Trains CROs and study site personnel on assigned protocols and addresses protocol queries as they arise</li>
<li>Participates in the assessment of CROs and study vendors</li>
</ul>
<p><b>Position Requirements:</b></p>
<ul>
<li> BS/MS in a relevant scientific discipline with 8+ years or PhD/PharmD with 5+ years of experience in early clinical drug development in the biotech/pharmaceutical industry performing the responsibilities described above</li>
<li>Experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2) and knowledge of drug development process and clinical deliverables from IND through clinical proof-of-concept</li>
<li>Excellent understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations</li>
<li>Ability to perform role responsibilities largely independently</li>
<li>Proven leadership skills and ability to bring out the best in others on a cross-functional team</li>
<li>Able to provide effective leadership through influence across organizations on partnered programs</li>
<li>Detail-oriented mindset with excellent oral and written English communication skills</li>
<li>Must be willing to work onsite at least 4 days a week</li>
</ul>
<p>The estimated base salary range for this role is $238,000 - $245,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.</p></div><p></p>

Associate Director, Clinical Scientist

Sarah Cannon Research Institute

<div><p><b>It&rsquo;s More Than a Career, It&rsquo;s a Mission.<br>
</b></p><p><br>
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
</p><p></p><p><b>Our Mission<br>
</b></p><p><br>
People who live with cancer &ndash; those who work to prevent it, fight it, and survive it &ndash; are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
</p><p></p><p>As the <b>Director of Hematology and Hospital Research Operations </b>you will be responsible for the overall clinical and data operations that involve Hematology, and/or hospital involved trials. The scope includes study operations, clinical operations, program development, and trial management. You are responsible for the development and execution of key strategies that support growth and execution of commitments to pharma and CRO partners. You are responsible for departmental goals, financial performance, quality assurance, oversight, and contracted obligations. The Director must have managerial, leadership skills, and excellent organizational abilities and will work closely with the administrative and physician leadership. Other responsibilities include:
</p><ul><li><p>Oversees Sites working closely with the Site Manager and Site management team
</p></li><li><p>Problem solves clinical situations along with the Site staff and site leaders as they arise. Engages hospital leadership, if necessary.
</p></li><li><p>Assists in developing and executing Sarah Cannon Research Institute internal and external strategies
</p></li><li><p>Provides operational oversight, leadership and direction in the execution and management of trials
</p></li><li><p>Assesses quality of data and performance of clinical trials through internal mechanisms as well as in partnership with site, monitors and sponsors. Develops action plans to address performance gaps.
</p></li><li><p>Monitors patient accrual rates and implements action plans for accrual issues
</p></li><li><p>Assesses organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures
</p></li><li><p>Meets with hospital administrators and physicians as needed to assess performance of Site as well as to ensure contracted services are being provided by SCRI Site Support and other key departments such as Therapeutic Development, Regulatory, Budgets/Contracts, IT and QA
</p></li><li><p>Keeps executive and management team abreast of issues, progress, and risks related to trial operations
</p></li><li><p>Supports the development, implementation and evaluation of programs to promote recruitment, retention and continuing education of Site research staff
</p></li><li><p>Plans and facilitates meetings and committees to address clinical and operational research issues
</p></li><li><p>Ensures the integrity of data/information, providing recommendations for corrective action when necessary
</p></li><li><p>Attends and participates in all required key meetings including both internal SCRI and at Site
</p></li><li><p>Proactively handles standard of care issues or conflict of interest issues
</p></li><li><p>Assesses and works with Research Sites to ensure compliance
</p></li><li><p>Assists in development and tracking of goals for each Site and reports out at least quarterly
</p></li><li><p>Oversees Site operations specific to hospital impacted studies and hematology research operations
</p></li><li><p>Supports strategic and tactical plans for oncology site growth
</p></li><li><p>Represents company vision to sponsors, site colleagues and affiliated organizations
</p></li><li><p>Communicates to all Research Site's performance standards and expectations
</p></li><li><p>Works with other team members in SCRI Operations department to ensure communication and responsibility are effective among the groups
</p></li><li><p>Collaborates with training and education to ensure continuing education and training to investigators and Research Site staff
 </p></li><li><p>Monitors data status through weekly and monthly reporting
</p></li><li><p>Establish accurate and consistent productivity expectations and revise as needed.
</p></li><li><p>Make recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity.
</p></li><li><p>Develops departmental annual goals and objectives and ensure alignment with organizational mission, vision, and values
</p></li><li><p>Builds and manage strategic internal and external relationships
</p></li><li><p>Monitors expenses and stay within budget
</p></li><li><p>Assists in the creation, development and execution of SOPs, WI and job aids
</p></li><li><p>Meets with leadership team regularly to develop goals and strategies for growth as well as evaluate progress, keep abreast of issues and risks related to research operations
</p></li></ul><p></p><p>Qualified candidates should have:
</p><ul><li><p>Knowledge of clinical research process
</p></li><li><p>General knowledge of research regulatory and Quality Assurance guidelines
</p></li><li><p>An Associate&rsquo;s Degree, Bachelor Degree is preferred
</p></li><li><p>At least three years of experience in leadership
</p></li><li><p>At least three years of experience in oncology, specifically blood cancers
</p></li><li><p>At least three years of experience working in research
</p></li></ul><p></p><p><i>Applications for this position will be accepted through March 23, 2026.
</i></p><p></p><div><p><b>About Sarah Cannon Research Institute<br>
</b></p><p><br>
Sarah Cannon Research Institute (SCRI) is one of the world&rsquo;s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI&rsquo;s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S.
<br>
<br>
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That&rsquo;s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.
<br>
<br>
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
</p></div><p></p><p>McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson&rsquo;s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
<br>
<br>
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.<br>
</p><p><br>
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
</p><p></p><p>McKesson job postings are posted on our career site: careers.mckesson.com .
</p><p></p><p><i>We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</i></p></div>

Director of Hematology and Hospital Research Operations

UT Southwestern Medical Center

WHY UT SOUTHWESTERN?
<br>With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
<br><br>
JOB SUMMARY
<br>Work under minimal supervision to meet the educational needs of the clinical research enterprise as part of the Office of Clinical Research Education and Training team. Support staff and faculty learning to promote the safe and ethical conduct of clinical research including good clinical practices, clinical trial operations, clinical research systems and clinical research policies across UT Southwestern. This position will have the opportunity to shape clinical research training programs at UTSW, create original content and deliver seminars and training to staff and faculty across the institution.
<br><br>
BENEFITS
<br>UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
<br>PPO medical plan, available day one at no cost for full-time employee-only coverage
<br>100% coverage for preventive healthcare-no copay
<br>Paid Time Off, available day one
<br>Retirement Programs through the Teacher Retirement System of Texas (TRS)
<br>Paid Parental Leave Benefit
<br>Wellness programs
<br>Tuition Reimbursement
<br>Public Service Loan Forgiveness (PSLF) Qualified Employer
<br>Learn more about these and other UTSW employee benefits!
<br><br>
EXPERIENCE AND EDUCATION
<br><br>
Required
<br>Education
<br>Master's Degree and
<br>Bachelor's Degree in related field
<br><br>
Experience
<br>5 years of related human subjects research experience with Master's Degree.
<br>7 years of related experience with Bachelor's Degree
<br>Advanced knowledge of the federal research regulations and industry standards for the conduct of human subjects research
<br><br>
Preferred
<br>Experience
<br>Demonstrated experience developing and delivering educational materials
<br><br>
Licenses and Certifications
<br>(CCRP) CERT CLINICAL RESEARCH PROF and
<br>CIP research certificate.
<br><br>
JOB DUTIES
<br>Assess the research-related education and training needs for the UT Southwestern campus. Identify learning gaps and barriers, and develop a comprehensive educational program for the human subject research enterprise.
<br>Use principles of clinical research adult learning to plan and develop materials for use in educational programs geared to the target audiences and experience levels.
<br>Working with subject matter experts as needed, deliver educational offerings in appropriate and varied advanced technology formats. Develop and maintain applicable websites.
<br>Develop tools to evaluate the effectiveness of research-related training programs.
<br>Plan, develop, and coordinate of new employee orientation for research personnel in collaboration with the Clinical Research Offices and the Center for Translational Medicine (CTM).
<br>Assist in the planning, development, and coordination related to initial and ongoing competencies of research personnel in collaboration with the Office of Clinical Research.
<br>Collaborate in the planning, development, and coordination of research staff development initiatives of the Human Research Protection Program, Office of Clinical Research, and aims of the Clinical and Translational Science Award (CTSA).
<br>Collaborate with other stakeholders in the planning development and coordination of educational materials geared to the public to promote understanding of research, recruitment efforts and participation in research.
<br>Develop and maintain policies, procedures, and guidance documents to be used throughout the UT Southwestern campus.
<br>Perform other duties as assigned.
<br>SECURITY AND EEO STATEMENT
<br><br>
Security
<br>This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
<br><br>
EEO
<br>UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

Clinical Research Educator, Office of Clinical Research

Pfizer

<div><div>The Clinical Development Scientist (Director) ensures scientific integrity and participant safety in clinical trials, designs and executes high-quality studies, maintains compliance, manages risks and emerging clinical issues, and supports interpretation and communication of clinical data. This role is the primary contact for internal and external stakeholders for clinical aspects the protocol, supports strategic development, and may provide matrix management.</div><div></div><div>
Job Responsibilities</div><ul><li><div>
Leadership</div><ul><li><div>
Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. May be accountable for program level clinical deliverables.</div></li><li><div>
Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.</div></li><li><div>
May provide matrix management support to one or more clinical colleagues.</div></li></ul></li><li><div>
Content Creation</div><ul><li><div>
Provides clinical input to support development of the protocol design document (PDD).</div></li><li><div>
Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.</div></li><li><div>
Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.</div></li><li><div>
Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.</div></li></ul></li><li><div>
Clinical &amp; Safety Oversight</div><ul><li><div>
Provides clinical input to the development of data collection tools.</div></li><li><div>
Responsible for providing clinical input to statistical analysis plan (SAP), tables, listings, figures (TLFs) and blinded data review (BDR).</div></li><li><div>
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.</div></li><li><div>
Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.</div></li><li><div>
Inputs to, reviews and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations.</div></li><li><div>
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.</div></li><li><div>
Serves as the primary contact with external investigators and internal study team for questions relating to clinical aspects of protocol</div></li><li><div>
Reviews, reports and manages protocol deviations.</div></li><li><div>
Reviews patient level and cumulative data per the data review plan across one or more studies.</div></li><li><div>
Reviews safety data, serious adverse event (SAE) reports, targeted medical events (TMEs), designated medical events (DMEs) and ensures clinical documents (eg ICD) are updated as required.</div></li><li><div>
Tracks and reconciles SAEs across a study and leads presentation of data during Safety Review Team meetings.</div></li><li><div>
Ensures trial master file (TMF) compliance for clinical documents</div></li></ul></li><li><div>
Clinical Reporting</div><ul><li><div>
May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses) if required.</div></li><li><div>
May support responsible colleagues with the development of responses to regulatory queries and Clinical Trial Applications (CTAs)</div></li><li><div>
Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.</div></li><li><div>
Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection</div></li></ul></li></ul><div></div><div>
BASIC QUALIFICATIONS</div><ul><li><div>
Advanced degree or professional certification in a health care related, scientific or technical discipline required</div></li></ul><ul><li><div>
Years of experience in biopharmaceutical industry in clinical research and development:</div><ul><li><div>
BA/BS with 8+ years of experience</div></li><li><div>
MBA/MS with 7+ years of experience</div></li><li><div>
PhD with 5+ years of experience</div></li></ul></li><li><div>
Clinical research experience in phase 3/pivotal space</div></li><li><div>
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management</div></li><li><div>
Demonstrated clinical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English, in relating to individuals both inside and outside Pfizer</div></li><li><div>
Demonstrated experience establishing, managing, and training teams in clinical development</div></li><li><div>
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.</div></li></ul><div></div><div>
PREFERRED QUALIFICATIONS</div><ul><li><div>
Oncology experience highly preferred</div></li><li><div>
Demonstrates a passion for helping patients</div></li><li><div>
Proven analytical skills with the ability to work on large data sets</div></li><li><div>
Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery</div></li><li><div>
Demonstrated scientific writing skills</div></li><li><div>
Has a global perspective and mindset; works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies both as a leader and a key contributor; works effectively with internal and external partners and investigators/medical professionals</div></li><li><div>
Has solid understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance</div></li><li><div>
Proficient with basic IT; efficiently using a computer and telecommunications (voice and video)</div></li><li><div>
Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned</div></li><li><div>
Must have the relevant personality features and competencies supporting the responsibilities:</div><ul><li><div>
Demonstrates effective problem-solving, and agile decision-making in execution of clinical responsibilities</div></li><li><div>
Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies</div></li><li><div>
Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development</div></li><li><div>
Promotes team health and exemplifies Pfizer&rsquo;s leadership behaviors and actionable attitudes</div></li><li><div>
Has foresight and judgment in complex decisions:</div><ul><li><div>
Leverages a variety of communication tools and techniques to communicate results</div></li><li><div>
Builds partnerships across the company to achieve the needs of the program</div></li><li><div>
Collaborative problem solving (handles conflict constructively)</div></li><li><div>
Promotes innovation and takes appropriate risks to challenge the status quo to enhance the efficiency of current processes</div></li><li><div>
Ability to work proactively and independently, organize tasks, time and priorities of self and others</div></li></ul></li></ul></li></ul><div></div><div>
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS</div><div></div><div>
Global travel may be required</div><div></div><div>
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.</div><br>
<div></div>
The annual base salary for this position ranges from $176,600.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer&rsquo;s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life&rsquo;s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site &ndash; U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.<div></div><div>
Relocation assistance may be available based on business needs and/or eligibility.</div><div></div><div><div><div><div><div><div><div><div><div>
Sunshine Act</div><div>
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider&rsquo;s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.</div></div></div></div></div></div></div></div></div><div></div><div>
EEO &amp; Employment Eligibility</div><div>
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.</div><div></div><div>
Pfizer endeavors to make <div>www.pfizer.com/careers</div> accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email <div>disabilityrecruitment@pfizer.com</div>. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.</div><div></div>
Medical</div><div></div>

Clinical Development Scientist, Director

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