clinical data coordinator

Catalyst Clinical Research

<div>Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.<div><div><div> 
The Clinical Data Coordinator (CDC) is a key member of the Clinical Development Operations, Data Management Team. The Clinical Data Coordinator will provide data management support for all assigned studies. The CDC Prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts. This will be accomplished with through the use of EDC and SAS software.<ul><li> 
 Assists in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.</li></ul><ul><li> Supports the coding schedule defined in the data management plan.</li></ul><ul><li> Performs manual data listing reviews and submits queries as appropriate.</li></ul><ul><li> Assists in determining when each patient has no more data quality issues, based on EDC, coding, and SAS based queries. Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.</li></ul><ul><li> Coordinates the query management system functions.</li></ul><ul><li> Assists in performing final patient reviews and database lock activities.</li></ul><ul><li> Assists in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, laboratory data) from external vendors</li></ul><ul><li> Performs relevant review/reconciliation of 3rd party data.</li></ul><ul><li> Reviews query responses and ensures data quality.</li></ul><ul><li> May draft or update documents for the data management plan.</li></ul><ul><li> May assist with the SAE reconciliation process.</li></ul> 
Education: Bachelor&rsquo;s degree in related discipline and one year of related experience; or high school diploma. 
Required Skills:<ul><li> Proficient with Microsoft Office Suite.</li></ul><ul><li> Excellent written and oral communication skills.</li></ul><ul><li> Strong organizational, problem-solving, and analytical skills.</li></ul><ul><li> Ability to manage priorities and workflow.</li></ul><ul><li> Versatility, flexibility, and a willingness to work within constantly changing priorities.</li></ul><ul><li> Proven ability to handle multiple projects and meet deadlines.</li></ul><ul><li> Strong interpersonal skills.</li></ul><ul><li> Ability to deal effectively with a diversity of individuals at all organizational levels.</li></ul><ul><li> Commitment to excellence and high standards.</li></ul><ul><li> Creative, flexible, and innovative team player.</li></ul><ul><li> Ability to work independently and as a member of various teams and committees.</li></ul><ul><li> Good judgement with the ability to make timely and sound decisions.</li></ul>
. Ability to be discrete with sensitive company information.</div></div></div></div>

Clinical Data Coordinator Trainee

ICON Strategic Solutions

<div>
 ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
 
 
 We are currently seeking a Clinical Data Coordinator I to join our diverse and dynamic team. As a Clinical Data Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
 
 
 
 What You Will Be Doing
 
 
 
 <ul>
 <li>
 Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
 </li>
 <li>
 Review clinical and third-party data based on edit specifications and data review plans.
 </li>
 <li>
 Issue clear, accurate, and concise queries to investigational sites.
 </li>
 <li>
 As required, communicate effectively with peers, clinical data scientist and functional management.
 </li>
 <li>
 Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.).
 
 
 </li>
 </ul>
 
 Your profile
 
 
 
 <ul>
 <li>
 Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.
 </li>
 <li>
 Basic knowledge of clinical data management within the pharmaceutical or biotechnology industry.
 </li>
 <li>
 Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
 </li>
 <li>
 Strong attention to detail and the ability to work effectively in a fast-paced environment.
 </li>
 <li>
 Excellent communication skills and the ability to collaborate with cross-functional teams.
 </li>
 <li>
 Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
 
 
 </li>
 </ul>
 
 What ICON Can Offer You
 
 
 
 Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
 
 
 In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
 
 
 
 Our Benefits Examples Include
 
 
 
 <ul>
 <li>
 Various annual leave entitlements
 </li>
 <li>
 A range of health insurance offerings to suit you and your family&rsquo;s needs.
 </li>
 <li>
 Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
 </li>
 <li>
 Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
 </li>
 <li>
 Life assurance
 </li>
 <li>
 Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
 
 
 </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 
 
 At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
 
 
 If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
 
 
 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.
 
 
 Are you a current ICON Employee? Please click here to apply
 
 
</div>

CDC I

Virginia Commonwealth University

<div><div><div><h3 class="jobSectionHeader">Sr. Clinical Research Coordinator - School of Medicine, Neurology
</h3><div><div><ul><li>45001106
</li></ul></div><div><ul><li>907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
</li></ul></div><div><ul><li>Research
</li></ul></div><div><ul><li>Staff
</li></ul></div><div></div><div><ul><li>School Of Medicine MBU</li></ul></div></div><div> 
</div><div>Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU&rsquo;s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer. 
 
https://vcujobs.com/why-richmond

Benefits: All full-time university staff are eligible for VCU&rsquo;s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

Unit: School of Medicine

Department: Neurology

Duties &amp; Responsibilities:

This position would serve as the Sr. Clinical Research Coordinator for the Center for Inherited Myology Research Program. This program is responsible for developing disease modifying and other innovative therapies for individuals with muscular dystrophy. In this role, the incumbent works with a group that leads an international network aimed at achieving this objective. 
For all clinical research studies assigned, the Sr. Clinical Research Coordinator is responsible for coordinating clinical research activities in a compliant and efficient manner from study initiation to close out. Under the direction of the Principal Investigator (PI), collaborates with all members of the clinical research team to ensure all federal, state, university and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Core responsibilities are listed below along with other tasks and duties as assigned.

Core Responsibilities:

Responsibility 1 (30%): Research and Clinical Trial Coordination/Study Conduct
<ul>
<li>Independently coordinate study recruitment activities: pre-screening, screening</li>
<li>Access allowable data capture/retrieval systems and interact with a variety of health care delivery systems to identify potential study participants</li>
<li>Conduct and document the initial and ongoing informed consent process for research participants throughout study participation and follow up</li>
<li>Coordinate the enrollment of participants, coordinate and file randomization documents; notifying applicable individuals of registration/randomization (PI, participant, study team, pharmacist, etc.)</li>
<li>Support the PI and other study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements</li>
<li>Support the orientation and training of new research team members and other staff</li>
<li>Work with PI and program staff to ensure all required study close-out activities are complete</li>
<li>For assigned studies, coordinate clinical research processes and documentation which may include: filing and office organization, creation of job aids, conducting protocol related training, research participant scheduling, ordering of study materials and supplies, and scheduling of meetings</li>
</ul>
Responsibility 2 (25%): Regulatory and Compliance Requirements
<ul>
<li>Understand and adhere to all human subject protection and IRB regulations required for clinical research</li>
<li>Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns</li>
<li>Participate in meetings with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements</li>
<li>Coordinate auditing and monitoring activities for assigned studies</li>
</ul>
Responsibility 3 (25%): Data Management
<ul>
<li>Assist PI and study team members in the management of study data for new and ongoing clinical research studies assigned</li>
<li>Maintain study files according to GCP guidelines and in audit ready condition</li>
<li>For assigned studies, ensure subject data is entered into sponsor case report forms, databases and VCU systems in a timely manner and in accordance with sponsor and university</li>
<li>Review and respond to all queries within required time frames, seeking input from PI&rsquo;s and other study staff as appropriate</li>
</ul>
Responsibility 4 (20%): Clinical Skills
<ul>
<li>Complete VCUHS orientation and training modules as required for the department and clinical research projects</li>
<li>Conduct applicable clinical activities only as approved and required for each clinical research project</li>
<li>All clinical skills must be conducted in VCUHS approved clinical areas only. Any protocol required clinical skill requires current VCUHS competency verification/documentation prior to performing each activity</li>
<li>Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills</li>
<li>Cannot perform any tasks that by state or local law require a license to perform, unless such license is on file and approved by VCU and VCUHS</li>
<li>Phlebotomy, vital signs, electrocardiograms and point of care testing will be a routine part of the job; hence the requirement for formal clinical education, experience and an active license</li>
</ul>
Qualifications:

Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s Degree (health or life sciences, nursing or similar) or equivalent related 5+ years experience</li>
<li>Ability to obtain Clinical Research Coordinator certification (CCRC, CCRP, CCRA) within one year of hire date</li>
<li>Ability to obtain CNA, CMA or EMT within 6 months of hire date</li>
<li>Highly competent with computer software, including database, spreadsheet and word processing applications</li>
<li>Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU</li>
</ul>
Preferred Qualifications
<ul>
<li>Master&rsquo;s Degree (health or life sciences, nursing or similar)</li>
<li>RN, LPN, CAN, CMA or EMT with active license</li>
<li>Experience in human subjects research in participants with neurological disorders</li>
<li>Familiarity with eTMF software, RedCap, RedCap Cloud and/or other EDC</li>
<li>Experience administering validated survey instruments</li>
</ul>
Salary Range: $70,000 - $80,000

FLSA Exemption Status: Exempt 
 
Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Fully Onsite

Contact Information: 
Contact Name: Kelly Barnes 
Contact Email: Kelly.Cecil@vcuhealth.org</div></div></div></div>

Sr. Clinical Research Coordinator - School of Medicine, Neurology

Encompass Health

<div><div>Patient Assessment Standards Coordinator Career Opportunity 
Join a Team That Puts Your Passion for Detail First 
Are you searching for a fulfilling career as a Patient Assessment Standards Coordinator? Look no further; join our team for a journey where your work is a meaningful contribution to patient well-being. As a Patient Assessment Standards Coordinator, you are vital to ensuring the highest standards of patient care, as your role involves ensuring patient assessments are compliant with established standards. This is more than a profession; it's a career close to home and heart, where your dedication significantly impacts the lives of those in our care. If you're passionate about promoting excellence in patient assessments, join our dedicated team. 
 
A Glimpse into Our World 
At Encompass Health, you'll experience the difference the moment you become a part of our team. Working with us means aligning with a rapidly growing national inpatient rehabilitation leader. We take pride in the growth opportunities we offer and how our team unites for the greater good of our patients. Our achievements include being named one of the &quot;Worlds Most Admired Companies&quot; and receiving the Fortune 100 Best Companies to Work For&reg; Award, among other accolades, which is nothing short of amazing. 
 
Starting Perks and Benefits 
At Encompass Health, we are committed to creating a supportive, inclusive, and caring environment where you can thrive. From day one, you will have access to:
<ul><li>Affordable medical, dental, and vision plans for both full-time and part-time employees and their families.</li>
<li>Generous paid time off that accrues over time.</li>
<li>Opportunities for tuition reimbursement and continuous education.</li>
<li>Company-matching 401(k) and employee stock purchase plans.</li>
<li>Flexible spending and health savings accounts.</li>
<li>A vibrant community of individuals passionate about the work they do!</li> 
</ul> 
Be the Patient Assessment Standard Coordinator you always wanted to be
<ul><li>Assure accurate data extraction from clinical documentation.</li>
<li>Coordinate timely submission of data for Medicare patients.</li>
<li>Educate and support staff on proper and accurate documentation.</li>
<li>Act as the primary resource for problem-solving regarding Quality Indicator coding and IRF-PAI completion.</li>
<li>Work to improve process of QI coding and all other data collection specific to IRF-PAI.</li>
<li>Ensure IRF-PAI data is entered and transmitted accurately.</li>
<li>Ensure IRF-PAI data is transmitted to CMS/UDS within time frames specified for admission/discharge.</li>
<li>Review, interpret and collect data on each patient in preparation for completion of the IRF-PAI.</li>
<li>Collaborate with team on identification of potential comorbidities or accurate CMG/RIC categories.</li>
<li>Ensure all discharged patient records contain the required elements.</li>
<li>Complete chart audit to allow for timely UDS export and CMS transmission.</li> 
</ul> 
Qualifications
<ul><li>Licensed or certified clinician in healthcare (RN, LPN, PT, PTA, OT, COTA, SLP, Recreational Therapist, Respiratory Therapist, case manager/social worker)</li>
<li>QI Credentialed</li>
<li>Obtain UDS IRF PPS Certification after 2 years in the PASC role and before the 3rd-year anniversary.</li>
<li>Ability to perform assessments.</li>
<li>1 year of healthcare experience.</li>
<li>Attend all EHC IRF-PAI trainings.</li>
<li>Preferred: Experience in rehab or post-acute care, proficient teaching, and communication skills</li> 
</ul> 
The Encompass Health Way 
We proudly set the standard in care by leading with empathy, doing what's right, focusing on the positive, and standing stronger together. Encompass Health is a trusted leader in post-acute care with over 150 nationwide locations and a team of 36,000 exceptional individuals and growing!
At Encompass Health, we celebrate and welcome diversity in our inclusive culture. We provide equal employment opportunities regardless of race, ethnicity, gender, sexual orientation, gender identity or expression, religion, national origin, color, creed, age, mental or physical disability, or any other protected classification.
We're eager to meet you, and we truly mean that. Join our family and let's make a difference together!</div></div>

Patient Assess Standards Coord

Accenture

Skill required: Clinical Data Services - Clinical eTMF Management 
Designation: Clinical Data Svs Associate 
Qualifications:Bachelor of Pharmacy
 
Years of Experience:1 to 3 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. Strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices. 
What are we looking for? &bull;Adaptable and flexible &bull;Ability to perform under pressure &bull;Problem-solving skills &bull;Detail orientation &bull;Ability to establish strong client relationship
 
Roles and Responsibilities: Document Administrators are responsible for carrying out format check of documents requiring eCTD compliance for New Drug Application/Marketing Authorization Submission. The format check ensures that the technical quality of submission documents in eCTD compliant and meets the document format standards (e.g., PDF property checks, good documentation practice and bookmark/hyperlink checks).
 
Bachelor of Pharmacy

Clinical Data Svs Associate

Exelo Technologies Inc

<ul><li>Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines.</li><li>Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities.</li><li>Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy.</li><li>Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.</li><li>Support data cleaning and validation activities to ensure completeness and accuracy of study data.</li><li>Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.</li><li>Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.</li><li>Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.</li><li>Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM), and collaborate with the study team to develop and implement risk mitigation strategies.</li><li>Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).</li><li>Supervise and provide guidance to junior CDM staff on assigned studies.</li><li>Perform additional CDM-related duties as required.</li></ul>Qualification Requirements:<ul><li>Bachelor&rsquo;s degree in a health-related, scientific, or equivalent field.</li><li>5&ndash;8 years of experience in Clinical Data Management role.</li><li>Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.</li><li>Hands-on experience with multiple Electronic Data Capture (EDC) systems.</li><li>Familiarity with additional CDM tools and analytics platforms preferred.</li><li>Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.</li><li>Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.</li><li>Excellent written and verbal communication skills.</li><li>Strong organizational skills with keen attention to detail.</li><li>Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.</li></ul>Job Types: Full-time, ContractPay: $75,000.00 - $100,000.00 per yearWork Location: Remote

Clinical Data Manager

LEO  CLINICAL DIAGNOSTIC CENTRE LLP

We are looking for a Patient Coordinator cum Data Entry Executive for our Scanning Room in Kannur. The role involves coordinating with doctors, assisting patients, and managing accurate data entry of medical reports. The ideal candidate should be patient-friendly, responsible, and detail-oriented.Key Responsibilities:<ul><li>Coordinate with doctors to ensure accurate and timely reporting.</li><li>Assist patients and manage smooth workflow in the scanning room.</li><li>Perform data entry of patient details and medical records with accuracy.</li><li>Organize and maintain scanned documents securely and systematically.</li><li>Provide courteous and caring support to patients during the process.</li><li>Ensure confidentiality and quality in patient data management.</li></ul>Requirements:<ul><li>Degree or Diploma in any field.</li><li>Experience in the Medical field preferred (freshers can also apply).</li><li>Strong communication and coordination skills.</li><li>Good computer and data entry proficiency.</li><li>Pleasant personality with a caring attitude toward patients.</li><li>Candidates from Kannur preferred.</li><li>Willing to work second shift (up to 8:00 PM).</li><li>Female candidates preferred.</li><li>Candidates with a two-wheeler will be given preference.</li></ul>Job Type: Full-timePay: Up to &#8377;20,000.00 per monthWork Location: In person

Patient Care Coordinator cum Data Entry

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