clinical trial manager

Roche

<div>
 At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
 
 
 The Position
 
 
 We are seeking a Clinical Study Manager to lead the operational execution of our secondary data use Real World Evidence (RWE) activities and international clinical studies. In this role, you will coordinate end-to-end study operations across global sites, ensuring that our clinical programs deliver high-quality data safely, efficiently, and ethically. You will work within a highly collaborative, matrixed team environment where your leadership directly helps us bring medical innovations to patients faster.
 
 
 
 Your Responsibilities
 
 
 <ul>
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 Lead Study Teams: Build and guide cross-functional, borderless study teams, establishing clear accountabilities, deliverables, and a psychologically safe environment where everyone can thrive
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 Manage End-to-End Trial Operations: Maintain comprehensive study plans, risk mitigation strategies, site selection procedures, and vendor oversight protocols from activation through to clinical closure
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 Oversee Financials &amp; Agreements: Manage study budgets, track metrics, review work orders, and negotiate study agreements to ensure highly cost-effective operations with minimal variances
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 Drive Global Regulatory Compliance: Ensure absolute adherence to international clinical trial guidelines (such as Good Pharmacovigilance Practices and Good Pharmacoepidemiology Practices), relevant local regulations, and inspection readiness
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 Direct Vendor &amp; Site Deliverables: Maintain strict oversight of external vendors, tracking performance metrics, resolving systematic operational issues, and organizing necessary training
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 Develop Strategic Recruitment Plans: Analyze trial feasibility data across multiple countries to make data-driven recommendations on site distribution, patient numbers, and retention strategies
 
 
 
 </li>
 </ul>
 
 Who You Are
 
 
 You are a proactive, strategic operational leader with a passion for clinical excellence and cross-functional collaboration. You bring a growth mindset, excel at solving complex operational problems under tight deadlines, and possess deep listening and empathy skills that inspire your teams.
 
 
 
 To be successful in this role, you bring:
 
 
 
 <ul>
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 Proven Clinical Leadership: Demonstrated experience leading successful study teams through all operational stages of clinical studies or secondary data use projects
 </li>
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 Regulatory Expertise: A clear understanding and practical experience applying global clinical quality requirements, regulations, and pharmacovigilance standards
 </li>
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 Strategic Planning &amp; Risk Management: Strong organizational awareness with a proactive planning mindset, including the ability to embed operational contingencies
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 Financial &amp; Vendor Acumen: Experience successfully managing trial budgets, processing vendor agreements, and handling external system integrations
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 Exceptional Communication: Well-developed written and verbal communication skills, with a proven ability to present clear directions, influence cross-functionally, and resolve conflicts
 
 
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 </ul>
 Together, we&rsquo;ll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases. Join us in building a healthier future!
 
 
 
 Compensation &amp; Benefits
 
 
 This position also offers an attractive benefits package.
 
 
 Learn more about how we reward our employees at Roche.
 
 
 This job is posted in multiple locations. If you're applying for the role in an alternative location where pay transparency regulations apply, the Talent Acquisition Partner will share the local pay information with you ahead of any business interview.
 
 
 Who we are
 
 
 A healthier future drives us to innovate. Together, more than 100&rsquo;000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
 
 
 Let&rsquo;s build a healthier future, together.
 
 
 
 Roche is an Equal Opportunity Employer.
 
</div>

Clinical Study Manager

Michigan Orthopaedic and Spine Surgeons

Job Summary We are seeking a dynamic and dedicated Clinical Research Coordinator to join our team and drive forward innovative clinical trials. In this vital role, you will oversee the daily operations of clinical studies, ensuring compliance with regulatory standards and maintaining meticulous documentation. Your energetic approach will facilitate smooth trial execution, patient engagement, and data integrity, ultimately contributing to groundbreaking medical advancements. This paid position offers an exciting opportunity to be at the forefront of clinical research, supporting the development of new therapies and treatments.Responsibilities<ul><li>Coordinate all aspects of clinical trials from start-up through closeout, ensuring adherence to protocols, FDA regulations, ICH GCP guidelines, and institutional policies.</li><li>Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure participant safety and protocol compliance.</li><li>Review medical records, laboratory results, and other documentation for accuracy and completeness in accordance with study requirements.</li><li>Conduct patient assessments including vital signs, blood sampling (phlebotomy), and other clinical procedures while maintaining strict confidentiality under HIPAA regulations.</li><li>Utilize electronic medical record (EMR) systems for data entry, management, and reporting; ensure data collection aligns with CDISC standards for clinical research data.</li><li>Supervise research staff and coordinate with multidisciplinary teams to facilitate efficient trial progress.</li><li>Prepare detailed reports, monitor study progress, and assist in audits or inspections by regulatory agencies such as the FDA.</li><li>Ensure compliance with clinical laboratory standards and maintain up-to-date knowledge of clinical development processes.</li></ul>Skills<ul><li>Proven supervising experience in a clinical research or healthcare setting with strong leadership capabilities.</li><li>Extensive knowledge of clinical trials management including protocol review, patient monitoring, and data collection procedures.</li><li>Familiarity with medical terminology, blood sampling techniques (phlebotomy), vital signs measurement, and clinical laboratory practices.</li><li>Proficiency in using statistical software for data analysis and interpretation related to clinical studies.</li><li>Deep understanding of FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and compliance management practices.</li><li>Experience working with EMR systems and research databases; ability to manage data accurately according to CDISC standards.</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent; ICH GCP certificate preferred.</li><li>Strong analytical skills with attention to detail in documentation review and data management tasks.</li><li>Background in nursing or related healthcare fields is advantageous; clinical laboratory experience is highly valued. Join us to be part of a passionate team committed to advancing healthcare through meticulous research coordination!</li></ul>Pay: $27.00 - $31.00 per hourBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Coordinator

Sarah Cannon Research Institute

<div>
 
 It&rsquo;s More Than a Career, It&rsquo;s a Mission.
 
 
 
 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.
 
 
 
 Our Mission
 
 
 
 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.
 
 
 The Clinical Trial Central Screener (CTCS) will be responsible for centralized clinical support for patient screening at SCRIs network of community-based medical oncology practices. The CTCS will partner with various SCRI departments (including but not limited to Personalized Medicine, Genospace, Therapeutic Development, Research Operations) for central screening services. The services will include 1) clinical trial patient identification 2) remote chart review for clinical appropriateness 3) communication with site personnel when appropriate clinical trial candidates are found.
 
 
 
 Duties include but are not limited to:
 
 
 
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 Clinical support for clinical trial central screening process
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 Serve as a liaison between SCRI network sites and Personalized Medicine Operations team to provide feedback and make adjustments to processes and technology tools
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 Aid in the enhancement of SCRI&rsquo;s precision medicine software platform, Genospace, to more efficiently match patients to clinical trials
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 Escalate appropriate issues to supervisor to enable timely resolution of any issues during the central screening process
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 Support the deployment, training, and utilization of Genospace at SCRI network sites
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 Lead and facilite routine internal and external cross-functional meetings
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 Build and maintain strategic relationships across the organization
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 Other duties as assigned
 
 
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 </ul>
 
 Mandatory:
 
 
 The following are mandatory expectations of all SCRI employees.
 
 
 
 <ul>
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 Practices and adheres to the &ldquo;Code of Conduct&rdquo; philosophy and &ldquo;Mission and Value Statement.&rdquo;
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 During your employment with SCRI, you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
 
 
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 </ul>
 
 Knowledge:
 
 
 A body of information needed to perform tasks; May be obtained through education, training or experience.
 
 
 
 <ul>
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 Knowledge of pharmaceutical industry, regulatory process, clinical trials and medical terminology
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 Business Experience &ndash; Experience working in a clinical research environment (within a SMO, CRO, sponsor, site) and a deep understanding of the oncology clinical research setting is strongly preferred.
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 Knowledge and interpretation of clinical research protocols, and experience in a clinical setting analyzing patient charts is required.
 
 
 </li>
 </ul>
 
 Skills:
 
 
 The proficiency to perform a certain task.
 
 
 
 <ul>
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 Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player. Excellent verbal and written communication skills.
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 Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
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 Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigators and site staff) using collaborative negotiation skills.
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 Excellent organizational and priority management skills.
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 Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
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 Ability to work within established timelines, in a fast-paced environment.
 
 
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 Abilities:
 
 
 An underlying, enduring trait useful for performing duties.
 
 
 
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 Problem solving skills in fast-paced environment
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 Interpersonal skills and detailed-oriented
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 Detail-oriented and meticulous
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 Demonstrate ability to positively influence others in a team environment
 
 
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 </ul>
 
 Minimum Qualifications:
 
 
 
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 Bachelor's Degree in Nursing or Licensed Registered Nurse
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 3+ years of experience as a research nurse, preferably within clinical research
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 Experience in clinical trials required
 </li>
 <li>
 Must be able to read a protocol and match patients with a protocol
 
 
 </li>
 </ul>
 
 About Sarah Cannon Research Institute
 
 
 
 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 850 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 in the past decade. SCRI&rsquo;s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
 
 
 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. For more information regarding benefits through our parent company, McKesson, please click here.
 
 
 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.
 
 
 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:
 
 
 McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
 
 
 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.
 
 
 McKesson job postings are posted on our career site: careers.mckesson.com.
 
 
 
 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.
 
</div>

Clinical Trial Central Screener

Teak Research Consults

Teak Research Consults specializes in Phase II- IV with two locations in Lawrenceville and Dunwoody GAJob Summary The Clinical Trials Coordinator is responsible for the day‑to‑day execution of clinical research activities in accordance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. With a minimum of three years of hands‑on clinical trial coordination experience, this role ensures the smooth conduct of study visits, accurate documentation, timely data entry, and effective communication with participants, investigators, and study sponsors. The coordinator supports all operational aspects of assigned studies&mdash;including screening, enrollment, visit management, safety reporting, and regulatory compliance&mdash;while maintaining high standards of professionalism, organization, and participant care. This position requires strong attention to detail, the ability to manage multiple priorities, and a commitment to supporting high‑quality clinical research.Responsibilities<ul><li>Coordinate all aspects of clinical trials, ensuring adherence to protocols and regulatory guidelines.</li><li>Monitor patient progress and safety throughout the study, including conducting vital signs assessments and managing patient documentation.</li><li>Review and maintain accurate documentation related to clinical trials, including data collection and management.</li><li>Collaborate with cross-functional teams to ensure compliance with FDA regulations and standards.</li><li>Handling, packaging, and shipping of processed lab samples</li><li>Handling, storing, and processing study drug</li><li>Creating source document</li><li>Conduct patient recruitment, screening, and informed consent processes while adhering to HIPAA regulations.</li><li>Manage clinical laboratory activities, including blood sampling and phlebotomy as required by the study protocols.</li><li>Ensure proper training of staff on clinical trial procedures and compliance management.</li><li>Informed consenting process</li><li>Screening of research patient to determine eligibility</li><li>Vast Knowledge in electronic Clinical Outcome Assessment</li></ul>Qualifications<ul><li>3+ years research experience</li><li>Associates/ Bachelor's degree in a scientific, health related (preffered) or relevant experience in lieu of education</li><li>Strong background in clinical trials management with knowledge of Good Clinical Practice (GCP).</li><li>Familiarity with medical terminology, FDA regulations, and compliance requirements.</li><li>Experience in documentation review, patient monitoring, data collection, and data management.</li><li>Proficiency in using electronic medical record (EMR) systems and statistical software for data analysis.</li><li>Skills in phlebotomy and blood sampling techniques.</li><li>Excellent analytical skills with the ability to interpret complex data sets effectively.</li><li>Knowledge of clinical development processes and the ability to work collaboratively within a research setting. This role is essential for advancing clinical research initiatives while ensuring the highest standards of patient care and regulatory compliance.</li><li>Good communication, organization, and interpersonal skills</li><li>Good computer skills including working knowledge of a PC and Microsoft office</li><li>In depth knowledge of state and federal Regulatory guidelines related to research</li><li>Applicants residing in the Atlanta area are strongly preferred.</li></ul>Job Types: Part-time, ContractPay: From $24.00 per hourBenefits:<ul><li>Referral program</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>Clinical research: 3 years (Required)</li><li>Clinical trials management: 3 years (Preferred)</li></ul>Ability to Commute:<ul><li>Lawrenceville, GA 30043 (Required)</li></ul>Work Location: In person

Clinical Trials Coordinator

Worldwide Clinical Trials

<div>Who we are
We&rsquo;re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world&rsquo;s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs &ndash; in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What Clinical Operations does at Worldwide
At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the lives of patients.
As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs.
Through regular touchpoints and coaching conversations with your Line Manager, we ensure that your professional development remains a top priority. We offer a clear career path and development that can lead to Clinical Trial Manager roles. We take pride in our accessible Executive Leadership team, who are equally committed to advancing science and surmounting obstacles to make a difference in the lives of patients around the world.
We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial. Experience a world of difference with us at Worldwide!
What you will do
<ul><li>Responsible for managing the research activities at sites participating in Worldwide&rsquo;s clinical research projects
</li><li>Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded
</li><li>Conduct study initiation visits (SIVs)
</li><li>While most of the site management efforts will be performed remotely, you will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements
</li></ul>What you will bring to the role
<ul><li>Excellent interpersonal, oral, and written communication skills in English
</li><li>Superior organizational skills with attention to detail
</li><li>Ability to work with little or no supervision
</li><li>Proficiency in Microsoft Office, CTMS, and EDC Systems
</li></ul>Your experience
<ul><li>5+ years of experience as a Clinical Research Associate
</li><li>4-year university degree OR Nursing Degree
</li><li>Experience in CNS/Neurology is required; Psychiatry is strongly preferred
</li><li>Candidates must reside in the Central United States
</li><li>Willingness to travel regionally required
</li></ul>At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
 
 
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): 
 
United States of America - $97,000.00 - $193,000.00 
 
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .</div>

Senior Clinical Research Associate - CNS/Psychiatry - Central U.S. - Remote

American Oncology Network

<div>Location:
Remote Position
Pay Range:
$57,699.20 - $107,140.80<h1 class="jobSectionHeader">
Job Description Summary:</h1>
The Research Study Activation Coordinator is responsible for facilitating the activation of clinical research studies within a healthcare research network setting. This role ensures that all administrative, regulatory, and operational tasks are completed efficiently to initiate clinical trials in compliance with institutional policies, sponsor requirements, and regulatory standards. The coordinator serves as a liaison between site network, study sponsors, investigators, and internal teams, ensuring seamless study start-up processes
Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.<h1 class="jobSectionHeader">
Primary Key Performance Areas:</h1>
KPA 1 &ndash; Management and Oversight of Study Start-up Activities for Multi-Research Site Network<ul><li>
Effectively manage all tasks related to study feasibility, site readiness, and initiation of clinical trials.</li><li>
Coordinate timely and accurate submission of study-related documents with site and regulatory colleagues.</li><li>
Maintain strict adherence to Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines during study activation.</li><li>
Act as the central point of contact for sponsors, investigators, and internal teams, ensuring effective communication and collaboration throughout the activation process.</li><li>
Provide clear, timely updates on the status of study activation activities to all stakeholders.</li></ul>
KPA 2 &ndash; Provide Contract and Budget Coordination<ul><li>
Facilitate contract negotiations and budget finalizations in collaboration with legal and financial teams.</li><li>
Monitor budget approvals and milestone tracking to ensure alignment with project objectives.</li></ul>
KPA 3 &ndash; Facilitate and Implement Process Improvement<ul><li>
Identify and implement opportunities for improving study activation workflows and reducing inefficiencies.</li><li>
Maintain accurate and comprehensive documentation of all activities in compliance with institutional policies and regulatory requirements.</li><li>
Deliver training sessions to research staff on protocol requirements, regulatory standards, and activation processes.</li><li>
Support team members in developing expertise in clinical trial activation tasks.</li></ul><h1 class="jobSectionHeader">
Position Qualifications/Requirements:</h1>
Education:.<ul><li>
High school education required</li><li>
Bachelor&rsquo;s degree in life sciences, healthcare, or a related field</li></ul>
Certifications/Licenses:<ul><li>
Certification in clinical research (e.g., CCRP, CCRC, or equivalent) preferred</li></ul>
Previous Experience:<ul><li>
Minimum 2-3 years of experience in clinical research or a related field</li><li>
Strong knowledge of clinical trial processes, IRB requirements, and regulatory guidelines</li><li>
Excellent organizational and multitasking skills with a high level of attention to detail.</li><li>
Effective communication and interpersonal skills to collaborate with diverse stakeholders.</li><li>
Proficiency in research management systems and Microsoft Office Suite.</li></ul>
Core Capabilities:<ul><li>
Analysis &amp; Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.</li><li>
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.</li><li>
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.</li><li>
Customer Service &amp; Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.</li><li>
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.</li><li>
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.</li><li>
Computer Skills:
<ul><li>Proficiency in MS Office Word, Excel, Power Point, and Outlook required.</li><li>
Prior experience with electronic medical records (EMR) is preferred</li><li>
Prior experience with clinical trial data entry systems (EDC) preferred</li><li>
Prior Clinical Trial Management Systems (CTMS) preferred.</li></ul></li></ul>
Travel: &lt;25%
Standard Core Workdays/Hours: Monday to Friday 8:00 AM &ndash; 5:00 PM.
#LI-Remote</div>

Research Study Activation Coordinator

NEL & SHEY MEDICAL CENTER AND RESEARCH

Job Summary We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this vital role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and maintaining the integrity of data collection. Your energetic approach will help drive innovative research forward, contributing to advancements in healthcare and patient outcomes. This paid position offers an exciting opportunity to work closely with multidisciplinary teams, coordinate complex studies, and make a meaningful impact in the clinical research field.Responsibilities<ul><li>Coordinate all aspects of clinical trials from start-up through closeout, including participant recruitment, scheduling, and follow-up.</li><li>Review and verify study documentation for accuracy, completeness, and regulatory compliance.</li><li>Monitor patient progress by conducting vital signs assessments, blood sampling (phlebotomy), and recording clinical data accurately.</li><li>Manage data collection and entry using electronic medical record (EMR) systems while ensuring adherence to CDISC standards for data formatting.</li><li>Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other applicable protocols.</li><li>Supervise research staff and collaborate with investigators to facilitate smooth trial operations.</li><li>Conduct clinical laboratory procedures and analyze results to support study objectives.</li><li>Maintain detailed documentation review processes, prepare reports, and support audits or inspections as needed.</li><li>Oversee patient safety by monitoring adverse events and ensuring proper reporting procedures are followed.</li><li>Utilize statistical software tools for data analysis to interpret research findings effectively.</li></ul>Requirements<ul><li>Proven supervising experience in a clinical research or healthcare setting.</li><li>Strong knowledge of clinical trials management, including FDA regulations and ICH GCP standards.</li><li>Excellent understanding of medical terminology, clinical laboratory procedures, and blood sampling techniques.</li><li>Experience with EMR systems, data management practices, and adherence to CDISC standards.</li><li>Ability to review complex documentation thoroughly while maintaining attention to detail.</li><li>Familiarity with clinical development processes and research methodologies.</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for California or equivalent certification is preferred.</li><li>Knowledge of HIPAA compliance requirements related to patient privacy and data security.</li><li>Skills in analysis using statistical software packages are advantageous.</li><li>Effective communication skills for coordinating with multidisciplinary teams and ensuring protocol adherence. Join us as a Clinical Research Coordinator to be at the forefront of groundbreaking healthcare research! Your dedication will help shape the future of medicine while gaining invaluable experience in a fast-paced, rewarding environment dedicated to excellence in clinical trials management.</li></ul>Pay: $16.00 - $18.00 per hourWork Location: In person

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6854 clinical trial manager jobs Near Me

Clinical Study Manager

Clinical Research Coordinator

Clinical Trial Central Screener

Clinical Trials Coordinator

Senior Clinical Research Associate - CNS/Psychiatry - Central U.S. - Remote

Research Study Activation Coordinator

Clinical Research Coordinator