clinical research nurse coordinator

MaineHealth

<div><p><b>Description</b><br>
</p><p><br>
Management/Leadership<br>
Req #: 59494</p><p></p><p><br>
Summary:</p><p>
This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research. This Research Nurse Coordinator Supervisor will work at the direction of the Manager, Clinical Trials Office, playing a key role in the delivery of our Oncology therapeutic clinical trials mission to provide the highest quality research conduct and the best experience possible to our research participants. This role will serve as an educational resource to nurses conducting clinical research studies, supervising staff, overseeing training and ongoing operational support of Oncology Research Nurse Coordinators.</p><p>
A hybrid work schedule from our Scarborough, Maine location is available for this position. A resume or CV AND Cover Letter are required to be considered for this position.</p><p>
Learn more about the MaineHealth Institute for Research in this short video!</p><p></p><p>
Required Minimum Knowledge, Skills, and Abilities (KSAs)</p><p></p><ul><li><b>
Education: </b>See &quot;License/Certifications&quot;</li><li><b>
License/Certifications: </b>Current license to practice as a Registered Nurse in the State of Maine. Current Clinical Research Coordinator Certification (ACRP or SOCRA) required.</li><li><b>
Experience: </b>5+ years of research experience is required. MH research experience is preferred. Thorough knowledge of theory, practice, principles, processes and issues of nursing usually acquired through 2-3 years of clinical experience.</li><li><b>
Additional Skills/Requirements Required: </b>Demonstrated ability to serve in a role as a leader or a mentor. Ability to manage complex projects through all phases of development, implementation, and follow-up.</li><li><b>
Additional Skills/Requirements Preferred: </b>N/A</li></ul><br>
<p></p><br>
<br>
Additional Information<br>
<br>
With a career at any of the MaineHealth locations across Maine and New Hampshire, you&rsquo;ll be working with health care professionals that truly value the people around them &ndash; both within the walls of the organization and the communities that surround it.<br>
<br>
We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow &ndash; programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.<br>
<br>
MaineHealth remains focused on investing in our care team and developing an inclusive environment where you can thrive and feel supported to realize your full potential. If you&rsquo;re looking to build a career in a place where people help one another deliver best-in-class care, apply today.<p></p><p><br>
If you have questions about this role, please contact lauren.robare@mainehealth.org</p></div>

Supervisor - Research Nurse Coordinator/RN - MaineHealth Institute for Research

Sarasota Memorial Health Care System

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  Department
  <br/>
  <br/>
 </strong>
 Research Institute
 <br/>
 <br/>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   This position is fully on-site, no option for remote*
   <br/>
   <br/>
  </li>
 </ul>
 Responsible for the coordination and conduct of clinical trials, under the direction of the Principal Investigator and the Manager/Director, in accordance with the standards of good clinical practice and FDA regulations.
 <br/>
 <br/>
 This position at our state of the art instutute is perfect for a well rounded clinical individual.
 <br/>
 <br/>
 <strong>
  Required Qualifications
  <br/>
  <br/>
 </strong>
 Require graduate of an accredited school of nursing or a diploma program. For new hires after 2012, Bachelor of Science Degree in nursing (BSN) is required within specified timeframe as outlined in the New Hire BSN Agreement policy (126.045).
 <br/>
 <br/>
 <ul>
  <li>
   Require certification as a Clinical Research Coordinator within one (1) year of eligibility.
  </li>
  <li>
   Require appropriate training in Human Subject Protection and Safe Shipping/Handling of Bio-Hazardous Specimens (must be completed within thirty (30) days of hire.
  </li>
  <li>
   Require a valid driver's license and the ability to drive to off-site locations.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Prefer knowledge of commonly used computer applications.
  </li>
  <li>
   Prefer experience in a clinical research and/or a medical/surgical or critical care setting.
  </li>
  <li>
   Prefer ability to initiate work without supervision.
  </li>
  <li>
   Prefer demonstrated proficiency in interpersonal skills with staff, subjects, families, physicians, and sponsor/auditors of clinical trials.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required License And Certs
  <br/>
  <br/>
 </strong>
 BLS: Basic Life Support/CPR
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 <br/>
 FL RN: FL Registered Nurse License
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 <br/>
 <strong>
  Employment Screening Requirements
  <br/>
  <br/>
 </strong>
 As part of Sarasota Memorial Health Care System&rsquo;s commitment to keeping people safe, all individuals providing care to vulnerable populations are required to undergo background screening through The Florida Care Provider Background Screening Clearinghouse. https://info.flclearinghouse.com/
</div>


Clinical Research Nurse (*on site position - no remote)*

University of Alabama, Birmingham

<div></div><div><div><div><div><div><b>Description</b><div></div><p>
The University of Alabama at Birmingham (UAB), Med - Cardiovascular Disease, is seeking a Clinical Research Coordinator II.</p><p><b>
General Responsibilities</b></p><p></p><ul><li><p><br>
To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.</p></li><li><p>
To support screening and participant eligibility determination, working with more senior team members to ensure compliance.</p></li><li><p>
To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).</p></li><li><p>
To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.</p></li></ul><p><b>
Key Duties &amp; Responsibilities</b></p><p>
We are seeking a Clinical Research Coordinator II to perform some of or all of the following duties and responsibilities, depending on the candidate's experience level:</p><ul><li><p>
Recruits, screens, consents, and enrolls participants.</p></li><li><p>
Implements study participant recruiting and screening protocols.</p></li><li><p>
Meets recruitment and enrollment goals.</p></li><li><p>
Manages all aspects of assigned clinical studies, including education.</p></li><li><p>
Collects, analyzes, and enters data for clinical trials and ensures quality control.</p></li><li><p>
Completes enrollment logs, informed consent logs, and all other data forms with high accuracy and attention to detail.</p></li><li><p>
Assists in the coordination of lab work.</p></li><li><p>
Prepares for study monitoring visits.</p></li><li><p>
Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, and IRB-, Good Clinical Practice-, and HIPAA regulations are followed.</p></li><li><p>
Uses REDCap and SPSS databases to enter and summarize study data.</p></li><li><p>
Monitors compliance of study procedures with federal, state, and university regulations.</p></li><li><p>
Performs general clerical duties (faxing, scanning, routing messages, coordinating the purchase of study supplies/materials).</p></li><li><p>
Works with minimal supervision, plans, organizes, and coordinates multiple work assignments, and establishes and maintains effective working relationships with others.</p></li><li><p>
Effectively and professionally communicates sensitive information and maintains confidentiality.</p></li><li><p>
Assist with regulatory submissions and duties.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p></p><p><b><br>
Annual Salary Range</b>: $50,050 - $81,330</p><div><br>
</div></div><div><b>
Qualifications</b><div></div><p>
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.</p><p><b>
Preferences</b></p><ul><li><p>
Previous clinical research experience, particularly in cardiovascular studies.</p></li><li><p>
Familiarity with REDCap and SPSS databases for data entry and analysis.</p></li><li><p>
Experience with Good Clinical Practice (GCP) guidelines and regulatory compliance.</p></li><li><p>
Knowledge of IRB processes and HIPAA regulations.</p></li><li><p>
Strong attention to detail for accurate data collection and documentation.</p></li><li><p>
Excellent interpersonal and communication skills for patient interaction.</p></li><li><p>
Ability to work independently with minimal supervision while managing multiple studies.</p></li></ul><p><br>
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.</p><div><br>
</div></div><div><b>
Primary Location</b><b>:</b> University</div><div><b>
Job Category</b><b>:</b> Clinical Research</div><div><b>
Organization</b><b>:</b> 311401000 Med - Cardiovascular Disease</div><div><b>
Employee Status</b><b>:</b> Regular</div><div><b>
Shift</b><b>:</b> Day/1st Shift</div><div><b>
Work Arrangement (final schedule to be determined by the department/hiring manager)</b><b>:</b> Onsite</div></div></div></div></div><div></div>

CLINICAL RESEARCH COORDINATOR II

Panoramic Health

Advancing Care Through Innovation
<br>Position is on-site Monday - Friday in Jacksonville, Florida
<br><br>
Florida Kidney Physicians, LLC (Jacksonville) 905 Beach Blvd. Suite B Jacksonville, FL 32250
<br><br>
<b>To learn more about Panoramic Science visit:</b> https://panoramichealth.com/clinical-research/
<br><br>
Come Join Panoramic's Science Divison!
<br><br>
Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects.
<br><br>
<b>Responsibilities include:</b><br>
<ul>
<li>Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study.</li>
<li>Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”).</li>
<li>Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available.</li>
<li>Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol.</li>
<li>Perform other duties and responsibilities as required, assigned, or requested.</li>
</ul>
<b>Qualifications:</b><br>
<ul>
<li>Bachelors’ degree required; Nursing or Health Science preferred.</li>
<li>Bilingual preferred (Spanish).</li>
<li>Minimum 2 years’ experience as a clinical research coordinator.</li>
<li>Therapeutic area experience in CKD, nephrology, or vascular access a plus.</li>
<li>Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations.</li>
<li>Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc.</li>
<li>Must be able to do an ECG.</li>
<li>Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.</li>
</ul>
The Company is committed to the principles of equal employment. We are committed to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment which is free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other status protected by federal, state, or local laws. The company is dedicated to the fulfillment of this policy in regard to all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment
<br><br>
For information about our Privacy Policy, please visit here

Clinical Research Coordinator in Jacksonville, Florida

University of Nebraska Medical Center

<div><div><h2 class="jobSectionHeader"><b>Requisition Details</b></h2>
<div><div><div>GENERAL REQUISITION INFORMATION
</div><p></p><div><div><div><div><b>EEO Statement:</b></div>
<div>UNMC is an Equal Employment Opportunity Employer, including an equal opportunity employer of protected veterans and individuals with disabilities.</div>
</div><br>
<div><div><b>Location</b></div> <div>Omaha, NE</div>
</div><br>
<div><div><b>Requisition Number:</b></div> <div>Staff_14325</div>
</div><br>
<div><div><b>Department</b></div> <div>Int Med Administration 50000581
</div></div><br>
<div><div><b>Business Unit</b></div> <div>College of Medicine</div>
</div><br>
<div><div><b>Reg-Temp</b></div> <div>Full-Time Regular</div>
</div><br>
<div><div><b>Work Schedule</b></div> <div>As directed by supervisor
</div></div><br>
<div><div><b>Remote/Telecommuting</b></div> <div>No remote/telecommuting opportunity</div>
</div><br>
<div><div><b>Position Summary</b></div>
<div>Perform translational research spanning the &ldquo;bedside to bench&rdquo;. Dual faceted role firstly with Fundamental patient recruitment with secondary responsibilities for laboratory based biomarker analysis. Coordinates day-to-day activities of research protocols which include screening, enrollment and monitoring of research participants.<br>
Works closely with the PI, and regulatory research manager to ensure accurate data collection, documentation, safety of participants and that the studies are performed accurately per guidelines/regulations and policies. Assesses literature to determine other relevant biomarkers. Interface with statistician, pathologists etc on all aspects of cancer biomarker development. Supervise trainees (medical students, residents, fellows) in clinical research.</div>
</div><br>
<div><div><b>Position Details</b></div>
<div><b>Additional Information</b></div>
</div><br>
<div><div><b>Posting Category</b></div> <div>Research - Non Academic</div>
</div><br>
<div><div><b>Working Title</b></div> <div>Clinical Research Coordinator</div>
</div><br>
<div><div><b>Job Title</b></div> <div>Clinical Research Coordinator</div>
</div><br>
<div><div><b>Salary Grade </b></div><div>RA22S</div>
</div><br>
<div><div><b>Appointment Type</b></div> <div>B1 - REG MGR PROF SALARY</div>
</div><br>
<div><div><b>Salary Range</b></div> <div>$53,000 - $79,500/annual</div>
</div><br>
<div><div><b>Job Requisition Begin Date</b></div> <div>12/31/2025</div>
</div><br>
<div><div><b>Application Review Date</b></div> <div>01/08/2025</div>
</div><br>
<div><div><b>Review Date Information:</b></div>
<div>Initial application review will begin on the date provided in the field above. Applications received prior to this review date will be considered. Applications received after the review date may be considered.</div>
</div><br>
</div></div></div><div><div>Required and Preferred Qualifications
</div><p></p><div><div><div><div><b>Required Education:</b></div> <div>Bachelor's degree or equivalent</div>
</div><br>
<div><div><b>If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major)</b></div>
<div><div>Biological/Health Science related field<br>
<br>
(Will consider six years related education and/or experience combined of which two years must include related post high school education)</div></div><br>
<div></div>
</div><br>
<div><div><b>Required Experience</b></div> <div>2 years</div>
</div><br>
<div><div><b>If any experience is required, please specify what kind of experience:</b></div>
<div>Experience in a clinical or laboratory research setting<br>
<br>
(Will consider six years related education and/or experience combined of which two years must include related post high school education)</div>
</div><br>
<div><div><b>Required License</b></div> <div>No</div>
</div><br>
<div><div><b>If yes, what is the required licensure/certification?</b></div>
</div><br>
<div></div><div><div><b>Required Computer Applications:</b></div> <div>Microsoft Excel, Microsoft Word, Microsoft Outlook</div>
</div><br>
<div><div><b>Required Other Computer Applications:</b></div>
</div><br>
<div></div><div><div><b>Required Additional Knowledge, Skills and Abilities:</b></div>
<ul><li>Hands on computer experience, specifically in the areas of data entry and data management.</li>
<li>A premium will be placed on flexibility, good interpersonal and communication skills in addition to willingness to learn.</li>
<li>Able to design, plan, and implement research projects.</li>
<li>The ability to work independently, while exercising judgment and decision-making skills.</li>
</ul>
</div><br>
<div><div><b>Preferred Education:</b></div> <div>Master's degree</div>
</div><br>
<div><div><b>If any degree/training is preferred, please specify the type:</b></div>
</div><br>
<div></div><div><div><b>Preferred Experience:</b></div>
</div><br>
<div></div><div><div><b>Preferred License:</b></div> <div>No</div>
</div><br>
<div><div><b>If yes, what is the preferred licensure/certification?:</b></div>
</div><br>
<div></div><div><div><b>Preferred Computer Applications:</b></div>
</div><br>
<div></div><div><div><b>Preferred Other Computer Applications:</b></div>
</div><br>
<div></div><div><div><b>Preferred Additional Knowledge, Skills and Abilities:</b></div>
<ul><li>Library research skills, medical database searches and retrieval, as well as internet research.</li></ul>
</div><br>
<div><div><b>Email to a Friend</b></div> <div>https://unmc.peopleadmin.com/postings/95241</div></div></div></div></div></div></div></div><p></p>

Clinical Research Coordinator

Orthocure Medical Center -Mirdif

<p><b>Role Overview</b></p><p>Orthocure Medical Center is seeking an experienced <b>Clinical Research Coordinator</b> to support our post‑operative research program. The role focuses on collecting clinical data, coordinating patient follow‑ups, and preparing case reports for <b>DHA submission</b> and <b>scientific publication</b>.</p><p><b>Key Responsibilities</b></p><ul><li>Conduct post‑operative patient follow‑ups to gather accurate clinical and recovery data.</li><li>Prepare and organize clinical documentation for research and reporting.</li><li>Draft, edit, and finalize clinical case reports in collaboration with surgeons and clinical teams.</li><li>Submit case reports to DHA following all regulatory requirements and formatting standards.</li><li>Prepare manuscripts for publication in recognized medical journals or scientific platforms.</li><li>Ensure compliance with ethical, scientific, and regulatory guidelines throughout the research process.</li><li>Coordinate with multidisciplinary teams to validate clinical details and ensure accuracy.</li><li>Maintain strict confidentiality and data integrity in line with UAE healthcare regulations.</li></ul><p><b>Mandatory Requirements (Strongly Emphasized)</b></p><ul><li>Must have proven experience publishing clinical case reports to DHA &mdash; including formatting, documentation, and submission workflows.</li><li>Must have experience preparing manuscripts for scientific publication (local or international journals).</li><li>Strong knowledge of DHA research and case submission standards.</li><li>Ability to write, edit, and structure scientific manuscripts according to CARE or journal guidelines.</li><li>Experience in clinical research coordination, including data collection and ethical compliance.</li><li>Strong understanding of medical terminology and orthopedic procedures.</li></ul><p>Job Types: Full-time, Part-time</p>

VCU Health System

<div>The Clinical Research Coordinator II is responsible for all aspects of conducting Phase I, II, III, and IV clinical trials for children, adult, and/or geriatric patients within internationally accepted standards of knowledge and understanding of the clinical research process and related regulations. The position duties include administrative and clinical study initiation processes, enrollment of patients, data collection, managing study patient follow-up, coordination of monitoring visits, and other administrative duties. The CRC II will also be a resource on general and VCU Health/VCU-specific clinical research processes for junior clinical research staff as well as University and health system staff.<p></p><p><b>
Essential Job functions</b></p><p></p><p>
Performance Expectation: Exhibit advanced competencies required to conduct clinical research<br>
Maintains an intermediate knowledge and understanding of the research process and related regulations;<br>
Maintains CCRC certification;<br>
Maintains membership in one (1) professional organization or hospital committee or high-profile activity;<br>
Maintains an intermediate level of knowledge including anatomy, disease process, medical terminology, tests and procedures relating to area of responsibility;<br>
Receives a minimum of 24 contact hours per year related to clinical research or job-related discipline documented by certificates of continuing education credits;<br>
Exhibits a high skill level of Microsoft Office and enrolls in classes as needed to achieve this level;<br>
Exhibits a high level of proficiency in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements;<br>
Develops a system for organizing, planning and controlling work-flow as related to specific activities with meticulous attention to detail and ordering of priorities; and<br>
Proven to function independently and proficiently as defined in the position essential functions with minimal supervision.</p><p></p><p>
Performance Expectation: Initiates studies<br>
Coordinates and facilitates site qualification visits;<br>
Assists in evaluation of all potential clinical research studies;<br>
Exhibits a working knowledge of the protocol, including background, rationale and description of investigational drug/device;<br>
Understands inclusion/exclusion criteria;<br>
Understands visits, tests, procedures and concomitant medications per protocol;<br>
Knowledgeable and confident to perform informed consent process including multiple consenting when appropriate;<br>
Maintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools and related documents;<br>
Maintains current inventory logs;<br>
Identifies study specific tests and procedure protocols, contacts appropriate departments and facilitates required training, certification and validation;<br>
Coordinates and facilitates site initiation visits;<br>
Assesses protocol requirements for patient care and provides necessary instruction;<br>
Collaborates with principal investigator to identify standard of care vs. nonstandard of care visits, hospitalizations, tests and procedures;<br>
Assembles, updates and maintains study packets, including consent, inclusion/exclusion check list, sponsor contact information and other related information;<br>
Prepares and distributes study specific flyers for ancillary staff and departments;<br>
Coordinates in-service/training/proctoring for physicians, departments and appropriate staff with supervision; and<br>
Ensures accurate progress of the protocol from planning to closure.<br>
<br>
Performance Expectation: Enrolls patients<br>
Diligently screens for patients in appropriate departments and participating physician offices;<br>
Completes and submits screening forms;<br>
Enters screen failures in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements;<br>
Maintains contact with principal investigators and sub-investigators to promote study and encourage patient enrollment;<br>
Available and prepared for patient enrollment;<br>
Promotes protocol compliance by being in clinic/physician&rsquo;s office/lab/OR when the subject is seen or leaves guidelines for investigator or sub-investigator to follow;<br>
Notifies and schedules sponsor clinicians, engineers and/or proctors for cases as necessary;<br>
Orders all protocol required labs, tests, procedures and medications accurately and according to VCU Health/VCU and area of responsibility SOPs;<br>
Manages studies prospectively to prevent protocol deviations;<br>
Enters patient enrollments and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements;<br>
Communicates regularly with PI, research nurse, and RCII team to ensure smooth and accurate enrollments; and<br>
Maintains screening and enrollment logs and provides to sponsor within established timeframe.</p><p></p><p>
Performance Expectation: Collects data<br>
Knowledgeable of both electronic and paper case report forms and procedures for completion and correction;<br>
Ensures all study documentation is accurately maintained, utilizing sponsor source documents or develops source documents as necessary;<br>
Completes case report forms at time of enrollment and at follow-up visits with appropriate source documentation;<br>
Returns case report forms to study sponsor in a timely manner;<br>
Responds to data clarification requests adequately and in a timely manner;<br>
Maintains a log of outstanding queries;<br>
Maintains confidentiality of Protected Health Information (PHI) and keeps all records secure;<br>
Requests charts and office notes from referring physicians and investigators to retrieve/capture data;<br>
Obtains all required signatures in a timely manner; and<br>
Processes, stores, and ships biospecimens according to local and study specific requirements.</p><p></p><p>
Performance Expectation: Manages study patient follow-up<br>
Follows study patient both in-patient and out-patient throughout course of study;<br>
Meets the timetable for protocol procedures and follow-up schedule;<br>
Ensures patient is scheduled for follow-up appointments;<br>
Orders all protocol required follow-up labs, tests, procedures and medications accurately and according to area of responsibility SOPs;<br>
Is present for all follow-up appointments when possible;<br>
Collects appropriate data during follow-up visit utilizing acceptable source documentation;<br>
Enters patient follow-up visits and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements;<br>
Monitors for adverse events, including daily review of study patient hospitalizations;<br>
Informs patients of changes in protocol and adverse events; re-consents patients as required;<br>
Makes every attempt to locate patient for follow-up and documents activity appropriately; and<br>
Collaborates with attending physician and principal investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.</p><p></p><p>
Performance Expectation: Manages monitoring visits<br>
Coordinates and schedules monitoring and study close-out visits;<br>
Schedules conference room, principal investigator, regulatory personnel, pharmacist and other staff in advance for sponsor visit;<br>
Ensures all data is entered on case report forms;<br>
Provides source documentation for all data;<br>
Maintains organized, complete study charts, including legible, accurate research notes;<br>
Requests and has available all medical records related to study patient; and<br>
Is available to monitor for clarification and corrections as needed.</p><p></p><p>
Performance Expectation: Communication and Problem-Solving<br>
Effectively shares and educates university and health system staff regarding the process for management of the segregation and routing of charges related to the treatment of patients enrolled in clinical trials;<br>
Independently identifies barriers to the segregation process and utilizes appropriate resources to resolve problems and remove barriers;<br>
Communicates in a timely professional manner with investigators, research staff, colleagues, and university and health system departments;<br>
Answers pages, phone messages and e-mails in a timely manner documenting communication as necessary;<br>
Takes the necessary initiative and collaborates with the interdisciplinary team members;<br>
Coordinates with research study staff and health system departments to identify and interact efficiently to maximize use of health system resources; and<br>
Capable of anticipating obstacles and proactively developing solutions to achieve identified goals.</p><p></p><p>
Performance Expectation: Additional Responsibilities<br>
Attends research meetings (e.g., staff, Scientific Review, Protocol Review. etc.);<br>
Assists in preparing agenda(s) for research meetings;<br>
Participates in continual learning, Performance Improvement (PI) projects and JCAHO Readiness;<br>
Functions within the guidelines of VCU Health, VCU, HIPAA, OSHA, JCAHO, federal, state and other regulatory agencies including OPRR, GCP and FDA guidelines;<br>
Participates in VCU Health/VCU quality assurance programs;<br>
Acts as liaison and &quot;Good Will Ambassador&quot; between research department, physician practices, hospital and staff;<br>
Assists in training new CRCs;<br>
Ensures all regulatory documents and correspondence are submitted to regulatory personnel in a timely manner;<br>
Meets department screening and accrual goals;<br>
Assists in recruiting and interviewing potential candidates for research positions;<br>
Assists in planning and design of new forms/flowsheets to be used in research activities;<br>
Performs other duties as assigned and/or participates in special projects in order to support the mission of clinical research at VCU Health;<br>
Provides assistance to team members as needed/requested;<br>
Accepts alternate assignments, as required, graciously; and<br>
Completes one (1) special project a year or presentation per year that impact clinical research at VCU Health/VCU.</p><p></p><p>
Patient Population: N/A<br>
<br>
<b>Employment Qualifications</b></p><p></p><p>
Required Education:</p><p>
Bachelor&rsquo;s degree in Health-related Field
</p><p></p><p>Licensure/Certification Required: None</p><p></p><p>
Licensure/Certification Preferred:</p><p>
Clinical Certification, and maintenance, of one of the following:</p><ul><li>
Certified Medical Assistant</li><li>
Certified Nursing Assistant
</li><li>Emergency Medical Technician</li><li>
Paramedic
</li><li>Or equivalent level of certification</li></ul><p><br>
</p><p>Basic Life Support (BLS) training for Healthcare Professionals</p><p></p><p>
Experience Required:<br>
Minimum of two (2) years of clinical research experience</p><p></p><p>
Experience Preferred:<br>
Three (3) years of work experience in clinical research;<br>
Five (5) years of work experience in disease/discipline;<br>
Significant previous patient records review and abstraction experience;<br>
Five (5) years of work experience in a team environment; and<br>
Experience training research staff.</p><p></p><p>
Cultural Responsiveness:
<br>
Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.<br>
<br>
<b>Working Conditions</b></p><p></p><p>
Periods of high stress and fluctuating workloads may occur.<br>
General office environment.<br>
Prolonged periods of working alone.</p><p></p><p><b>
Physical Requirements</b></p><p></p><p>
Lifting/ Carrying (0-50 lbs.), Push/ Pull (0-50 lbs.), Stoop, Kneel, Squat, Balance, Bending<br>
Work Position: Sitting, Walking, Standing</p><p><br>
Additional Physical Requirements/ Hazards</p><p></p><p>
Physical Requirements: Manual dexterity (eye/hand coordination), Finger Dexterity<br>
Hazards: none</p><p></p><p>
Mental/Sensory: Reasoning, Problem solving, Speak clearly, Reading, Logical Thinking<br>
Emotional: Steady pace, Able to handle multiple priorities</p><p></p><p>
EEO Employer/Disabled/Protected Veteran/41 CFR 60-1.4.</p></div>

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