clinical resource coordinator

Arizona Liver Health

<div><div>About Us:

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.</div> 
Job Summary:

Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II position in Tucson

Title: Clinical Research Coordinator II (CRC2)

Compensation: $27.50 to $33 per hour, depending on experience

Status: Full-time

Essential job functions/duties:

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
<ul>
<li>Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.</li>
<li>Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs.</li>
<li>Collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.</li>
<li>Develop management systems and prepare for study initiation</li>
<li>Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol</li>
<li>Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity about these protocols to staff and patients.</li>
<li>Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.</li>
<li>Responsible for meeting recruitment goals for each study.</li>
<li>May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.</li>
<li>Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.</li>
<li>Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.</li>
<li>Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.</li>
<li>Serves as a liaison to all physicians, employees, and third-party vendors.</li>
<li>Record data and study documentation</li>
<li>Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate.
<ul><li>Assign patient stipend pay card at screening</li>
<li>Document reason for screen-fail in real time</li>
</ul></li><li>Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:</li>
<li>Record data as directed using the appropriate media or platform</li>
<li>Follow procedures for access and security for electronic data entry</li>
<li>Review keyed data for accuracy as needed</li>
<li>Send data to the data collection center on a timely basis</li>
<li>Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports</li>
<li>Develop and/or edit source as needed independently or with Quality Assurance / Quality Control team to ensure compliance with protocol and EDC.</li>
<li>Correct and edit data as directed and as appropriate.</li>
<li>Informed Consent</li>
<li>Obtaining patient medical history and medication lists</li>
<li>Phlebotomy and basic laboratory tests</li>
<li>Processing &amp; shipping labs for central and local labs</li>
<li>Patient education and training</li>
<li>ECG</li>
<li>Administer questionnaires and assessments</li>
<li>Vital signs</li>
<li>Collect information for adverse event reporting</li>
<li>Assist with efficacy assessments</li>
<li>Data Entry and Query Resolution</li>
<li>Study drug administration, including injections</li>
<li>Tracking study supply inventory and reordering when necessary</li>
<li>Schedule patient visits in appropriate electronic systems</li>
<li>Documenting all patient visits and communications in progress notes</li>
<li>Document and record all AEs and SAEs as outlined in protocol</li>
<li>Monitor and report adverse events</li>
<li>Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.</li>
<li>Responsible for administrative duties including filing documents related to subject's participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.</li>
<li>Ensure W-9 and medical release forms are signed by subjects annually.</li>
<li>Management of site activities during audits and inspections</li>
<li>Management of ancillary staff as assigned
<ul><li>Train and supervise support staff (e.g., CRC I)</li>
<li>Mentor for externs</li>
<li>Train newly hired employees as either Research Assistant and/or CRC</li>
</ul></li></ul><ul><li>Prepare for quality assurance audits and regulatory inspections as needed</li>
<li>Act as contact person before, during and after audits and inspections</li>
<li>Provide all required documentation to auditors</li>
<li>Make all appropriate corrections as requested by auditors</li>
<li>Coordinate site response to audit/inspection findings.</li>
<li>Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.</li>
<li>Other responsibilities as delegated by manager.</li>
</ul>
Knowledge/Skills/Abilities required:
<ul>
<li>Minimum (2) years of experience working previously as a Clinical Research Coordinator for late phase clinical trials.</li>
<li>Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management).</li>
<li>A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.</li>
<li>Interpersonal and communication skills&mdash;interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources.</li>
<li>Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility protocol deviations, serious adverse events and other reporting requirements.</li>
<li>Able to perform all Job duties listed for Job Description for Phlebotomist</li>
<li>Know and understand all regulatory requirements associated with the conduct of the study assigned.</li>
</ul>
Travel requirements:
<ul>
<li>Some interoffice travel may be required with use of company vehicle or mileage reimbursement</li>
</ul>
Education, credentials, and/or trainings required:
<ul>
<li>Associates or Bachelor's degree in healthcare, clinical research management, or related required.</li>
<li>Master's degree or study-specific training preferred</li>
<li>GCP certification required at hire.</li>
<li>Experience and training in the conduct of clinical research and basic knowledge of medical terminology.</li>
<li>Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management)</li>
<li>Experience with data management and tracking software</li>
</ul>
Benefits &amp; Perks:
<ul>
<li>Health, Dental, Vision (with HSA plans and employer contribution)</li>
<li>3 weeks of PTO</li>
<li>5 days Sick Time</li>
<li>401K with 6% company match</li>
<li>Short &amp; Long Term Disability</li>
<li>CEUs / Educational Assistance</li>
<li>Shared company vehicles for required travel</li>
</ul>
Our company requires COVID-19 vaccinations for all current and future employees (&amp; temporary employees). Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.

EEO statement

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.</div>

Clinical Research Coordinator II (CRC2) Tucson

Evolution Research Group

<div>About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
Responsibilities:
General<ul><li>
Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.</li><li>
Develop draft source documents and review the documents for accuracy and clarity prior to study start up.</li><li>
Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.</li><li>
Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.</li><li>
Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.</li><li>
Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.</li><li>
Serve as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.</li><li>
Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.</li><li>
Contribute to the SOP review and development as delegated by the Site Director.</li></ul>
Study Management<ul><li>
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.</li><li>
Attend the investigator meeting for each assigned protocol, as appropriate.</li><li>
Completion of IRB study renewals and maintain copies of all IRB communications.</li><li>
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.</li><li>
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator</li><li>
Review and obtain informed consent from potential study volunteers.</li><li>
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.</li><li>
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.</li><li>
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Perform study close-out procedures.</li><li>
Store study records appropriately</li><li>
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.</li></ul>
Skills and Qualifications:<ul><li>
Education and experience<ul><li>
High School Diploma or its equivalent; College degree preferred.</li><li>
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator</li><li>
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.</li><li>
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.</li><li>
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.</li><li>
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.</li></ul></li><li>
Requirements<ul><li>
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.</li><li>
Excellent communication skills (interpersonal, written, verbal)</li><li>
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)</li></ul></li></ul></div>

Clinical Research Coordinator-FT CRC

University of Virginia

<div>The Division of Pulmonary and Critical Care Medicine at the University of Virginia&rsquo;s (UVA) School of Medicine is seeking applicants for a Clinical Research Coordinator 2 Licensed or Non-licensed or Clinical Research 3 Licensed or Non-licensed, to participate in clinical trials and registries. This position works closely with world-renowned Principal Investigators and other research team members who specialize in pulmonary fibrosis and sarcoidosis, diseases that cause progressive scarring of the lungs and shortness of breath. The Clinical Research Coordinators are tasked with consenting subjects, collecting data, maintaining trial documents, and ensuring compliance with regulatory and protocol guidelines. We are a Pulmonary Fibrosis Foundation Center of Excellence and WASOG/AASOG Certified Sarcoidosis Center. We are proud to serve patients from across the state of Virginia and surrounding states for their pulmonary specialty care.
Pulmonary fibrosis is the number one reason to receive a lung transplant in the United States, and we are dedicated as a research team to fighting this disease. We have a varied research portfolio including industry sponsored and NIH federally funded studies and registries. CRCs will have the opportunity to work on clinical trials that include new therapies for pulmonary fibrosis, sarcoidosis and lung transplant rejection. We also investigate precision genetics, matching patients&rsquo; genes to target therapy and using gene expression to identify predictive biomarkers for disease progression. Our investigators also closely examine the immune system to understand why and how some patients have susceptibility to progressive pulmonary disease.
Job Responsibilities:<ul><li>
Coordinate and implement clinical trial research studies, working closely with the Principal Investigators, Operational Managers, and other research team members during the performance of the trials.</li><li>
Collection of study data; prepare appropriate study documentation; ensuring compliance with protocol guidelines and requirements of regulatory agencies.</li><li>
Maintaining quality management of the trial portfolio.</li><li>
Recruitment, screening, and enrolling study participants who meet research criteria. Collect basic information through scripted and non-scripted interviews. Planning and executing tasks.</li><li>
Obtaining informed consent from study participants and maintaining telephone and in-person contact.</li><li>
Collection of subject data, maintaining appropriate logs, tracking participants, and preparing study materials.</li><li>
Processing, preparing and shipping laboratory specimens.</li><li>
In addition to the above job responsibilities, other duties may be assigned. 
 `</li></ul>
MINIMUM REQUIREMENTS
Non-licensed positions: 
Clinical Research Coordinator, 2 Non-Licensed 
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
Clinical Research Coordinator 3, Non-Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: Minimum of 3 years of clinical research experience required. Master&rsquo;s degree may substitute for 1 year of clinical research experience.<ul><li>Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.
</li></ul>Licensed positions:
 
To be considered for CRC 2-3 Licensed, candidates must be licensed to Practice in Clinical Profession such as (but not limited to):<ul><li>
Registered Nurse</li><li>
Athletic Training</li><li>
Pharmacology</li><li>
Medical Technology</li><li>
Physical Therapy</li><li>
Registered Respiratory Therapy</li></ul>
Clinical Research Coordinator, 2 Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: At least one year of clinical research experience.
Licensure: See above. 
Clinical Research Coordinator 3, Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: A minimum of 3 years of clinical research experience required. Master&rsquo;s or advanced degree may substitute for 1 year of clinical research experience.
Licensure: See above. 
PREFERRED QUALIFICATIONS<ul><li>
Organizational and planning tasks skills.</li><li>
Excellent attention to detail.</li><li>
Excellent verbal and written communication skills.</li></ul> 
PHYSICAL DEMANDS
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.
Salary will be commensurate with education and experience. This is an exempt-level, benefited position. Learn more about UVA benefits.
This is a restricted position, which is dependent on funding and is contingent upon funding availability.
This position is based in Charlottesville, VA, and is eligible for a hybrid schedule of four days on campus per week and one day remote, with additional on-site presence as needed, in accordance with UVA&rsquo;s remote work guidelines.
To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.
Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment.
HOW TO APPLY
Please apply online, by searching for requisition number R0077639. Complete an application with the following documents:<ul><li>
Resume</li><li>
Cover Letter</li></ul>
Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration.
Internal applicants: Apply through your Workday profile by searching &ldquo;Find Jobs.&rdquo;
Reference checks will be completed by UVA&rsquo;s third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, please contact Jeremy Brofft, Senior Recruiter at xmf9ad@virginia.edu.
The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Click here to read more about UVA&rsquo;s commitment to non-discrimination and equal opportunity employment.</div>

Clinical Research Coordinator (varying levels), Pulmonary and Critical Care

Stanford University

<div>Stanford University&rsquo;s Department of Neurosurgery is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical research studies. Studies may include drug/ device trials, longitudinal natural history studies, and other PI-initiated projects dealing with adult neuro-Oncology treatments. The CRCA will coordinate moderately complex aspects of two or more clinical studies and work under the close direction of the manager, senior coordinator, and principal investigator. The CRCA will manage data, enroll and follow patients on trial and assist with regulatory and financial requirements of the trials. We are seeking candidates with excellent both written and verbal communication skills and able to follow through with specifically assigned deliverables. There are opportunities for long term growth within the team, or the position can be a launching pad for a career in the biomedical sciences. This CRCA position is a full-time position, and a commitment of at least two years is required. CRCAs are expected to be available on site for up to 5 days a week. This position may require occasional evening and weekend hours.
Interested candidates, please apply with your resume and a cover letter. Please describe your background, interests, and future goals in the cover letter. 
Duties Include*:<ul><li>
Serve as the primary contact with research participants, sponsors, and regulatory agencies.</li><li>
Assist with the screening, recruiting, and obtaining consent of study participants. Review medical records and/or perform telephone or in-person interviews to gather data, as needed.</li><li>
Schedule subjects for appointments; contact participants with reminders or other requirements.</li><li>
Perform clerical duties in the preparation of regulatory documents and maintenance of study regulatory binder.</li><li>
Maintain subject study binders, including all forms and documents, (i.e. source data, consent forms, and master subject logs). File all appropriate correspondence.</li><li>
Extract data from source documents and complete case report forms and electronic data capture (EDC) forms for assigned studies. Resolve database queries as required.</li><li>
Collect, process and ship specimens in accordance with clinical protocol and IRB.</li><li>
Assemble study kits for study visits and order study supplies as needed.</li><li>
Prepare, administer, and score study questionnaires and tests as assigned. Perform quantitative review of forms, tests, and other measurements for completeness and accuracy.</li><li>
Participate in monitoring visits and regulatory audits.</li><li>Other duties may also be assigned.</li></ul> 
<div>DESIRED QUALIFICATIONS:<ul><li>
Bachelor&rsquo;s degree in the fields of Biology, Psychology or Neurosciences.</li><li>
Experience working with databases such as REDCap and Oncore.</li><li>
Experience processing and shipping samples.</li><li>
Have the necessary patience and resourcefulness to interact well with individuals and their families.</li><li>
Knowledge of data-related research and presentation of research data.</li><li>
Enjoy working directly with patients and their families.</li><li>
Is exceptionally organized and can balance multiple projects at one time.</li></ul> 
EDUCATION &amp; EXPERIENCE (REQUIRED):
Two year college degree and two years related work experience or a Bachelor&rsquo;s degree in a related field or an equivalent combination of related education and relevant experience. 
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):<ul><li>
Strong interpersonal skills.</li><li>
Strong oral and written communication skills.</li><li>
Proficiency with Microsoft Office.</li><li>
Knowledge of medical terminology.</li></ul> 
CERTIFICATIONS &amp; LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 
PHYSICAL REQUIREMENTS*:<ul><li>
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.</li><li>
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.</li><li>
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.</li><li>- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.</li></ul> 
WORKING CONDITIONS:
Occasional evening and weekend hours and overtime as required. 
WORK STANDARDS:<ul><li>
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.</li><li>
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.</li><li>
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.</li></ul> 
The expected pay range for this position is $34.56 to $40.30 per hour.
Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford&rsquo;s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.</div></div>

Clinical Research Coordinator Associate

DM Clinical Research

<div>The Clinical Research Coordinator II will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. 
DUTIES &amp; RESPONSIBILITIES<ul><li>
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.</li><li>
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:<ul><li>
a. Sponsor-provided and IRB-approved Protocol Training</li><li>
b. All relevant Protocol Amendments Training</li><li>
c. Any study-specific Manuals Training, as applicable</li><li>
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.</li></ul></li><li>
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.</li><li>
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.</li><li>
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.</li><li>
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.</li><li>
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.</li><li>
Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.</li><li>
Demonstrating adherence and compliance to the assigned protocols at their respective site(s).</li><li>
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)</li><li>
Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).</li><li>
Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)</li><li>
Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).</li><li>
Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.</li><li>
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.</li><li>
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).</li><li>
Being prepared for and available at all required company meetings.</li><li>
Submitting required administrative paperwork per company timelines.</li><li>
Occasionally attending out-of-town Investigator Meetings</li><li>
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives</li><li>
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent</li><li>
Facilitate effective communication between patients, healthcare providers, and research staff</li><li>
2Any other matters as assigned by management.</li></ul> 
KNOWLEDGE &amp; EXPERIENCE 
Education:<ul><li>
High School Diploma or equivalent required; Bachelor's degree preferred</li><li>
Foreign Medical Graduates preferred</li></ul>
Experience:<ul><li>
At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.</li></ul>
Credentials:<ul><li>
ACRP or equivalent certification is preferred</li></ul>
Knowledge and Skills:<ul><li>
Be an energetic, go-getter who is detail-oriented and can multi-task.</li><li>
Be goals-driven while continuously maintaining quality.</li><li>
Proficient communication and comprehension skills both verbal and written in the English language are required.</li><li>
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.</li></ul></div>

Clinical Research Coordinator II

Compunnel Inc.

<div>
 
 
 Job Title: Clinical Coordinator &ndash; Medical
 
 
 
 
 Business Area: Clinical &amp; Care Management
 
 
 
 
 Job Type: Subcon
 
 
 
 
 Location: Remote (Anywhere in Florida)
 
 
 
 
 Duration: 06 Months/Can be Extended
 
 
 
 
 Working hours: Day Shift
 
 
 
 
 Pay Rate: $24 to $25/HR
 
 
 
 
 
 
 
 Job Description:
 
 
 
 
 Position Purpose:
 
 
 
 Serve as a clinical resource within the Medical Management team, responsible for reviewing medical documentation and determining the medical necessity of services. This role ensures compliance with InterQual criteria and contract requirements, and facilitates appeal reviews by either approving cases or escalating to a Medical Director.
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Review all submitted materials including EMRs and supporting documentation to assess completeness and compliance.
 </li>
 <li>
 Apply InterQual criteria and contract guidelines to determine medical necessity.
 </li>
 <li>
 Make initial determinations on cases; approve or escalate to MD for further review.
 </li>
 <li>
 Prepare and submit appeal letters in accordance with NCQA and state regulations.
 </li>
 <li>
 Coordinate with internal departments and external review organizations for fair hearings and appeals.
 </li>
 <li>
 Maintain accurate logs and documentation for all appeal decisions.
 </li>
 <li>
 Stay current with NCQA, CMS, and state regulatory updates.
 </li>
 <li>
 Support continuity of care and ensure timely resolution of member and provider inquiries.
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 Education/Experience:
 
 
 <ul>
 <li>
 RN with 4+ years of clinical nursing or case management experience OR LPN/LVN with 5+ years of clinical experience
 </li>
 <li>
 Managed care or utilization review experience preferred
 </li>
 </ul>
 
 
 Licensure/Certification:
 
 
 <ul>
 <li>
 Valid RN, LPN, or LVN license in applicable state
 </li>
 <li>
 NCLEX certification and active US RN license preferred for offshore roles
 </li>
 </ul>
 
 
 Skills:
 
 
 <ul>
 <li>
 Strong understanding of InterQual and Milliman guidelines
 </li>
 <li>
 Familiarity with ICD and CPT codes
 </li>
 <li>
 Proficiency in Microsoft Word, Excel, and EMR systems
 </li>
 <li>
 Effective communication skills, both verbal and written
 </li>
 </ul>
 
 
</div>

Appeals Nurse

Children's Hospital Colorado

<div><h2 class="jobSectionHeader">Job Overview</h2>
<div>
<div><div><div>Senior Clinical Research Coordinator Neurology
The Clinical Research Coordinator Senior is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. This position will support the Neurogenetics team within the CCHRI, performing a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Facilitates the accomplishment of research programs and/or study goals. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under minimal supervision.
Additional Information:
Department: CCHRI - Operations 
Hours: 40 hours/week 
Shift: M-F, 8-4:30. This position has the flexibility to be a hybrid role. 
 
Duties &amp; Responsibilities<ul><li>
Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.</li><li>
Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.</li><li>
Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.</li><li>
Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements. Assists with the development of proposals or protocols. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.</li><li>
Human Subject Research Protection - Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Serves as a resource and trainer for issues related to professional guidelines and code of ethics. Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution.</li><li>
Leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Provides significant contribution and influence upon research work, activities and/or productivity of study teams. Leads a committee or task force under direction of a supervisor. Leads scientific or programmatic presentations. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. Implements with leadership team on the operational elements needed for the conduct of clinical and translational programs and/or studies.</li><li>
Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data and assists management with resolution. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and develops and implements retraining as appropriate. Adheres to and oversees the development and assessment of quality assurance processes. Identifies issues related to operational efficiency and shares results with team members and management. Recognizes when data agreements or special regulatory requirements are necessary and acts as a resource and mentor to determine when special contracts are necessary and escalates to stakeholders. Develops systems and/or frameworks for quality assurance processes in collaboration with leadership.</li><li>
Participates in and provides oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Comprehensive understanding of institutional process for the development of budgets. Proactively identify gap deficits and escalating.</li><li>
Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design.</li></ul>
Minimum Qualifications<ul><li>
Education: Bachelor&rsquo;s degree in a related field is required.</li><li>
Experience: Minimum of three (3) years of clinical, clinical support, and or clinical research related experience is required.</li><li>
Equivalency: Associate degree in a related field with (5) five years of clinical related experience may be considered in lieu of minimum education requirement.</li></ul> 
Salary Information 
Pay is dependent on applicant's relevant experience. 
 
Hourly Range: $25.95 to $38.93 
 
Benefits Information 
Here, you matter. As a Children&rsquo;s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.
As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.
Children&rsquo;s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year. 
 
EEO Statement 
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained. 
 
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.</div></div></div></div></div>

Senior Clinical Research Coordinator Neurology

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