clinical review specialist

SMA Healthcare

<p></p><div><div><div><div><div><p><b>Top reasons to work for SMA Healthcare:</b></p>
<ul><li>
Career growth and advancement potential</li><li>
Great benefits such as: Health, Dental, Vision, Life, &amp; Disability Insurance</li><li>
Tuition Reimbursement</li><li>
Paid Personal Leave and Paid Holidays</li><li>
403b Retirement Plan (matches one to one of employee contribution for the first 3%, then a 50% match on the next 6% of employee contribution)</li></ul><p><b>
Essential Job Functions:
</b></p><ul><li>Complete audits to assure services provided are current, accurate, and meet all documentation/compliance requirements in accordance with CARF, Medicaid, Department of Children &amp; Families (DCF)/LSF, HIPAA, and SMA standards.
</li><li>Ensure that documentation in medical records adequately supports the service code that was billed.
</li><li>Complete audits as assigned each month.</li>
<li>Identify and report trends and/or deficiencies to Clinical Compliance Manager.
</li><li>Writes legible, informative, and understandable notices of non-compliance issues identified through reviews of client records.</li>
<li>Gather and prepare required documentation for external audits, including desk audits.
</li><li>Stay updated with CARF, HIPAA, Medicaid, Department of Children &amp; Families/LSF, and SMA standards changes.</li>
<li>Assist the Clinical Compliance Manager and performs related work as required or assigned.</li>
<li>Performs miscellaneous job-related duties as assigned.</li>
</ul></div></div><br>
</div></div><div><div><div><div><p><b>Qualification Requirements: </b>To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
</p></div></div><br>
</div></div><div><div><div><div><p><b>Minimum Education and/or Experience: </b>A minimum of a Bachelor's Degree, preferably with a concentration in psychology, social work, mental health counseling, or human service-related field. Experience working in behavioral health preferred. Experience with Medicaid, DCF/LSF auditing and CARF accreditation is preferred.</p>
</div></div><br>
</div></div><div><div><div><div><p><b>Knowledge/Skills/and Abilities:
</b></p><ul><li>Knowledge in behavioral health, knowledge of current practices and documentation requirements regarding the care and treatment of the population served.
</li><li>Knowledgeable of CARF, HIPAA, Medicaid, Department of Children &amp; Families/LSF, and SMA standards and becomes familiar with changes.</li>
<li>Knowledge of administrative and data systems, procedures and processes for improving program effectiveness and efficiency.
</li><li>Knowledge of data collection, compilation, and reporting.
</li><li>Ability to prepare clear and concise reports.
</li><li>Knowledge of state regulatory policies and accreditation standards pertaining to mental health service delivery.
</li><li>Ability to train, consult, and present improvement recommendations to staff, committees, and others.
</li><li>Ability to evaluate and analyze systems problems and make recommendations for corrective actions.
</li><li>Ability to complete work under strict timelines, while maintaining flexibility to assist with emergent issues/concerns;
</li><li>Ability to establish and maintain effective working relationships with co-workers, medical and clinical professionals, and the general public.
</li></ul></div></div><br>
</div></div><div><div><div><div><p><b>Necessary Special Requirements: </b>Possession of a valid Florida driver's license, acceptable driving record, and proof of personal automobile insurance if required to drive an SMA vehicle and/or use a personal vehicle for SMA business. Complete State of Florida mandatory background screening prior to start of employment. Complete SMA required training during the first six (6) months of employment and updated if required.</p>
</div></div><br>
</div></div><div><div><div><div><p><b>Physical:</b> Mobility and ability to bend and reach during an 8?12-hour day. Able to lift a minimum of 10 pounds. Visual and auditory acuity sufficient to evaluate, intervene, treat, and record client health care needs. Fine motor skills for legible and accurate charting, daily correspondence, and presentation, either manually or orally. Routine 8-hour shifts. Work endurance ability to work 8?12-hour shifts with a meal break, as possible. Extra hours may be required. Work assignment locations may vary.</p>
</div></div><br>
</div></div><div><div><div><div><p><b>Application:</b>This class specification is intended to identify the class and illustrate the kinds of duties that may be assigned to its incumbents. It should not be interpreted as describing all the duties whose performance may ever be required of such an employee or be used to limit the nature and extent of assignments such individuals may be given.</p></div></div></div></div></div><p></p>

Clinical Review Specialist

Monogram Health

<div>
 <strong>
  Position:
 </strong>
 <strong>
  <em>
   Concurrent Review Ops Assistant
   <br/>
   <br/>
  </em>
 </strong>
 The
 <strong>
  Concurrent Review Ops Assistant
 </strong>
 is a key member of the Clinical Review Specialist Team that is responsible for critical administrative day-to-day tasks associated with operations to deliver transformative kidney care.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Assist in processing Health Plan(s) and Contracted Provider(s) daily files and uploads for all acute and post-acute admissions
  </li>
  <li>
   Assist with inpatient and concurrent calls to verify and confirm admission and obtain member information
  </li>
  <li>
   Assist with monitoring skilled nursing facility discharges
  </li>
  <li>
   Create Care Events as needed for new admissions to be followed by the Clinical Review Team
  </li>
  <li>
   Request clinical as needed; retrieve and document clinical from our EMR system(s).
  </li>
  <li>
   Communicate with the care team and other internal and external stakeholders
  </li>
  <li>
   Analyze data and develop reports/presentations
  </li>
  <li>
   Ability to multitask and prioritize in a busy work environment
  </li>
  <li>
   Maintain safe, secure, and healthy work environment by establishing and following standards and procedures and complying with legal regulations
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   High school diploma or GED required
  </li>
  <li>
   Minimum of two (2) years of experience analyzing and solving customer problems
  </li>
  <li>
   Proven experience working in the health care industry and working with medical terminology
  </li>
  <li>
   Firm grasp on administrative processes and organizational policies
  </li>
  <li>
   Understanding and appreciation of patient privacy laws, regulations, policies, and procedures.
  </li>
  <li>
   Demonstrated customer service and professional communication skills, both written and verbal. Organizational and time management skills, with ability to multitask and maintain attention to detail.
  </li>
  <li>
   Timely, reliable, and supportive of team goals and outcomes by completing daily tasks.
  </li>
  <li>
   Technically savvy when handling video and audio meetings.
  </li>
  <li>
   Proficient in Microsoft Office ? predominately Excel
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Benefits
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Comprehensive Benefits - Medical, dental, and vision insurance, employee assistance program, employer-paid and voluntary life insurance, disability insurance, plus health and flexible spending accounts
  </li>
  <li>
   Financial &amp; Retirement Support ? Competitive compensation, 401k with employer match, and financial wellness resources
  </li>
  <li>
   Time Off &amp; Leave ? Paid holidays, flexible vacation time/PSSL, and paid parental leave
  </li>
  <li>
   Wellness &amp; Growth ? Work life assistance resources, physical wellness perks, mental health support, employee referral program, and BenefitHub for employee discounts
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  About Monogram Health
  <br/>
  <br/>
 </strong>
 Monogram Health is a leading multispecialty provider of in-home, evidence-based care for the most complex of patients who have multiple chronic conditions. Monogram health takes a comprehensive and personalized approach to a person?s health, treating not only a disease, but all of the chronic conditions that are present - such as diabetes, hypertension, chronic kidney disease, heart failure, depression, COPD, and other metabolic disorders.
 <br/>
 <br/>
 Monogram Health employs a robust clinical team, leveraging specialists across multiple disciplines including nephrology, cardiology, endocrinology, pulmonology, behavioral health, and palliative care to diagnose and treat health issues; review and prescribe medication; provide guidance, education, and counselling on a patient?s healthcare options; as well as assist with daily needs such as access to food, eating healthy, transportation, financial assistance, and more. Monogram Health is available 24 hours a day, 7 days a week, and on holidays, to support and treat patients in their home.
 <br/>
 <br/>
 Monogram Health?s personalized and innovative treatment model is proven to dramatically improve patient outcomes and quality of life while reducing medical costs across the health care continuum.
</div>


Concurrent Review Operations Assistant

CorVel Corporation

<div><p>The Diagnostic Related Groups (DRG) Clinical Supervisor is responsible for performing DRG validation (clinical/coding) reviews of medical records and/or other documentation to determine correct DRG/coding that is clinically supported as defined by review methodologies specific to the contract for which review services are being provided. This involves completing medical review forms, accurately documenting findings and non-findings and providing clinical/policy/regulatory support for the determination.</p>
<p>
This is a remote position.</p>
<p><b>
ESSENTIAL FUNCTIONS &amp; RESPONSIBILITIES:</b></p>
<ul>
<li>Supervises all daily activities of the DRG Clinical Auditors</li>
<li>Demonstrated knowledge of, ICD-10-CM and PCS codes, and DRG coding, understanding of payer rules and regulations, including Medicare and Medicaid with the ability to work independently with minimal supervision and demonstrate initiative</li>
<li>Completes DRG audits as needed</li>
<li>Responsible for the overall integrity of the quality of diagnosis and procedure codes verified by the clinical review nurses, for inpatient records and documentation received with the accompanied claim</li>
<li>Responsible for holding the DRG Clinical Auditors to the quota and error/accuracy rate</li>
<li>Assists with team coverage and provide support when needed</li>
<li>May be required to travel overnight and attend meetings or training</li>
<li>Additional duties as assigned</li></ul><br>
<p></p>
<p><b>
KNOWLEDGE &amp; SKILLS:</b></p>
<ul>
<li>Clinical knowledge of medical necessity rules</li>
<li>Working knowledge of HIPAA Privacy and Security Rules</li>
<li>Ability to build strong working relationships both internally and externally</li>
<li>Strong attention to detail</li>
<li>Must possess problem solving, critical thinking skills</li>
<li>Minimal typing experience</li>
<li>Excellent written and verbal communication skills</li>
<li>Ability to think and work independently, while working in an overall team environment</li>
<li>Ability to work in a fast paced/production environment</li>
<li>Proficient in Microsoft Office applications</li></ul><br>
<p></p>
<p><b>
EDUCATION &amp; EXPERIENCE:</b></p>
<ul>
<li>N./L.V.N. preferred</li>
<li>CCS or CIC required with DRG auditing experience in ICD-10-CM, ICD-10 PCS</li>
<li>Proficient in Medicare, CMS guidelines and ICD-10 coding guidelines</li>
<li>Minimum of 3-5 years of inpatient/DRG auditing experience in a hospital setting and/or payer setting</li>
<li>A minimum of 2 years of supervisory experience dealing with clinical auditors is required</li>
<li>Experience with claims denials and appeals required</li></ul><br>
<p></p>
<p><b>
PAY RANGE:</b></p>
<p>
CorVel uses a market based approach to pay and our salary ranges may vary depending on your location. Pay rates are established taking into account the following factors: federal, state, and local minimum wage requirements, the geographic location differential, job-related skills, experience, qualifications, internal employee equity, and market conditions. Our ranges may be modified at any time.</p>
<p>
For leveled roles (I, II, III, Senior, Lead, etc.) new hires may be slotted into a different level, either up or down, based on assessment during interview process taking into consideration experience, qualifications, and overall fit for the role. The level may impact the salary range and these adjustments would be clarified during the offer process.</p>
<p>
Pay Range: $77,960 &ndash; $120,368</p>
<p>
A list of our benefit offerings can be found on our CorVel website: CorVel Careers | Opportunities in Risk Management</p>
<p>
In general, our opportunities will be posted for up to 1 year from date of posting, or until we have selected candidate(s) to fulfill the opening, whichever comes first.</p><br>
<p></p>
<p><b>
ABOUT CERIS:</b></p>
<p>
CERIS, a division of CorVel Corporation, a certified Great Place to Work&reg; Company, offers incremental value, experience, and a sincere dedication to our valued partners. Through our clinical expertise and cost containment solutions, we are committed to accuracy and transparency in healthcare payments. We are a stable and growing company with a strong, supportive culture along with plenty of career advancement opportunities. We embrace our core values of Accountability, Commitment, Excellence, Integrity and Teamwork (ACE-IT!).</p>
<p>
A comprehensive benefits package is available for full-time regular employees and includes Medical (HDHP) w/Pharmacy, Dental, Vision, Long Term Disability, Health Savings Account, Flexible Spending Account Options, Life Insurance, Accident Insurance, Critical Illness Insurance, Pre-paid Legal Insurance, Parking and Transit FSA accounts, 401K, ROTH 401K, and paid time off.</p>
<p><b>
CorVel is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.</b></p>
<p>
#LI-Remote</p></div>

Clinical Review Supervisor

Amerita, Inc

<div>
 <strong>
  Our Company
  <br/>
  <br/>
 </strong>
 Amerita
 <br/>
 <br/>
 <strong>
  Overview
  <br/>
  <br/>
 </strong>
 This role will be responsible for activities relating to the proper initiation, clinical review, submission, and follow up of prior authorizations. This role requires working knowledge of pharmacy benefits and prior authorization process.
 <br/>
 <br/>
 Shift: Monday-Friday 8:30am-5:30pm (CST)
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Initiate, process, and oversee the clinical review of prior authorization requests for medication and supply, ensuring compliance with payer requirements and clinical guidelines.
  </li>
  <li>
   Collaborate with healthcare providers, insurance companies, and patients to gather necessary clinical information and documentation to support prior authorization submissions.
  </li>
  <li>
   Submit prior authorization requests accurately and in a timely manner, utilizing electronic submission platforms and following established protocols.
  </li>
  <li>
   Knowledgeable to perform all PA functions.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   High School Diploma or GED or licensed/registered pharmacy technician or previous experience in Pharmacy
  </li>
  <li>
   1+ years pharmacy experience
  </li>
  <li>
   Pharmacy or healthcare-related knowledge
  </li>
  <li>
   Knowledge of pharmacy terminology including sig codes, and Roman numbers, brand/generic names of medication
  </li>
  <li>
   Basic math and analytical skills
  </li>
  <li>
   Intermediate typing/keyboard skills
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  About Our Line Of Business
  <br/>
  <br/>
 </strong>
 Amerita, an affiliate of BrightSpring Health Services, is a specialty infusion company focused on providing complex pharmaceutical products and clinical services to patients outside of the hospital. Committed to excellent service, our vision is to combine the administrative efficiencies of a large organization with the flexibility, responsiveness, and entrepreneurial spirit of a local provider. For more information, please visit www.ameritaiv.com . Follow us on Facebook , LinkedIn , and X .
 <br/>
 <br/>
 <strong>
  Additional Job Information
  <br/>
  <br/>
 </strong>
 <strong>
  Percentage of Travel:
 </strong>
 0-25%
 <br/>
 <br/>
 <strong>
  Salary Range
  <br/>
  <br/>
 </strong>
 USD $21.00 - $26.00 / Hour
</div>


Prior Authorization Specialist / Remote

Valley Medical Center

<div></div><div><div><div><ul><li><h6 class="jobSectionHeader"><b>Job Title:</b></h6>
 Clinical Documentation Specialist
</li><li><h6 class="jobSectionHeader"><b>Req:</b></h6>
 2026-0293
</li><li><h6 class="jobSectionHeader"><b>Location:</b></h6>
 VMC Main Campus
</li><li><h6 class="jobSectionHeader"><b>Department:</b></h6>
 Health Information Mgmt
</li><li><h6 class="jobSectionHeader"><b>Shift:</b></h6>
 Days
</li><li><h6 class="jobSectionHeader"><b>Type:</b></h6>
 Full Time
</li><li><h6 class="jobSectionHeader"><b>FTE:</b></h6>
 1
</li><li><h6 class="jobSectionHeader"><b>Hours:</b></h6>
</li><li><h6 class="jobSectionHeader"><b>City State:</b></h6>
 Renton, WA
</li><li><h6 class="jobSectionHeader"><b>Salary Range:</b></h6>
 Min $94,894 - Max $142,341/annual DOE</li></ul></div></div><br>
<br>
<br>
<br>
<p></p><p><b>Job Description:</b></p>
<p>VALLEY MEDICAL CENTER</p>
<p>
</p><p><b>JOB DESCRIPTION</b></p>
<p>
</p><p>The position description is a guide to the critical duties and essential functions of the job, not an all-inclusive list of responsibilities, qualifications, physical demands, and work environment conditions. Position descriptions are reviewed and revised to meet the changing needs of the organization.</p>
<p>
</p><p><b>TITLE:</b> Clinical Documentation Specialist RN</p>
<p>
</p><p><b>JOB OVERVIEW:</b> The Clinical Documentation Specialist position facilitates accurate documentation for severity of illness and quality in the medical record. This involves extensive record review, interaction with physicians, health information management professionals, and nursing staff. Active participation in team meetings and education of staff in the documentation improvement process is a key role.</p>
<p>
</p><p><b>DEPARTMENT:</b> Health Information Management</p>
<p>
</p><p><b>HOURS OF</b> <b>WORK:</b> Days Monday - Friday.</p>
<p>
</p><p><b>RESPONSIBLE TO:</b> Manager, Clinical Documentation Improvement</p>
<p>
</p><p>PREREQUISITES:</p>
<div>
<ul><li><p>Current unrestricted WA State Registered Nurse license, required.</p>
</li></ul>
<ul><li><p>Bachelor's degree in Nursing, preferred.</p>
</li></ul>
<ul><li><p>Minimum five years recent clinical experience as an RN working in an acute care setting or with experience in Utilization Review</p>
</li></ul>
<ul><li><p>Pass a pre-hire Clinical Exam with a minimum score of 70%</p>
</li></ul>
<ul><li><p>Effective communication with Providers</p>
</li></ul>
</div><p></p><p>QUALIFICATIONS:</p>
<div>
<ul><li><p>Knowledge of hospital clinical practice standards for physicians and other health care providers.</p>
</li></ul>
<ul><li><p>Knowledge of ancillary service departments, quality control and safety standards.</p>
</li></ul>
<ul><li><p>Critical thinking, problem solving and deductive reasoning skills.</p>
</li></ul>
<ul><li><p>Familiarity with health care audit and research design.</p>
</li></ul>
<ul><li><p>Knowledge of Pathophysiology and Disease process.</p>
</li></ul>
<ul><li><p>Functional knowledge of DRG coding systems.</p>
</li></ul>
<ul><li><p>Working experience with Utilization Review activities and general knowledge of JCAHO, PRO, HCFA, and other regulatory bodies.</p>
</li></ul>
<ul><li><p>Knowledge of third-party payer review, reimbursement systems and utilization monitoring requirements for acute care facilities.</p>
</li></ul>
<ul><li><p>Meet productivity guidelines.</p>
</li></ul>
<ul><li><p>Ability to learn/develop the skills necessary to perform and meet goal standards</p>
</li></ul>
<ul><li><p>Organizational, analytical, writing, and interpersonal skills</p>
</li></ul>
<ul><li><p>Dependable, self-directed, and pleasant</p>
</li></ul>
<ul><li><p>Critical thinking, problem solving and deductive reasoning skills</p>
</li></ul>
<ul><li><p>Knowledge of Pathophysiology and Disease Process</p>
</li></ul>
<ul><li><p>Basic Computer skills - familiarity with Windows based software programs</p>
</li></ul>
<ul><li><p>Knowledge of regulatory environment</p>
</li></ul>
<ul><li><p>Understand and support documentation strategies (upon completion of training)</p>
</li></ul>
<ul><li><p>Knowledge of Core Measure and Patient Safety Indicators (upon completion of training)</p>
</li></ul>
</div><p></p><p>UNIQUE PHYSICAL/MENTAL DEMANDS, ENVIRONMENT AND WORKING CONDITIONS:</p>
<p>
See Generic Job Description for Administrative Partner.</p>
<p>
</p><p>PERFORMANCE RESPONSIBILITIES:</p>
<p>
A. Generic Job Functions: <i>See Generic Job Description for Administrative Partner.</i></p>
<p>
B. Essential Responsibilities and Competencies</p>
<div>
<ul><li><p>Reviews EMR for completeness and accuracy for severity of illness and quality using the documentation strategies.</p>
</li></ul>
<ul><li><p>Accurate and timely record review.</p>
</li></ul>
<ul><li><p>Recognize opportunities for documentation improvement.</p>
</li></ul>
<ul><li><p>Initiates severity worksheet for inpatients.</p>
</li></ul>
<ul><li><p>Formulate clinically credible documentation clarifications.</p>
</li></ul>
<ul><li><p>Request documentation clarifications as appropriate for SOI, Core Measures, and Patient Safety.</p>
</li></ul>
<ul><li><p>Effective and appropriate communication with physicians.</p>
</li></ul>
<ul><li><p>Timely follow up on all cases and resolution of those with clinical documentation clarifications.</p>
</li></ul>
<ul><li><p>Communicates with HIM staff and resolves discrepancies.</p>
</li></ul>
<ul><li><p>Accurate input of data for reconciliation of case.</p>
</li></ul>
<ul><li><p>Provide necessary information and education to physicians and staff to facilitate the appropriate documentation goals.</p>
</li></ul>
<ul><li><p>Identify any barriers to completion of documentation goals with appropriate interventions.</p>
</li></ul>
<ul><li><p>Review of regulations and coding guidelines through seminars, meetings, and materials.</p>
</li></ul>
<ul><li><p>In cooperation with the director of PFS/HIM, present education sessions to physicians and other VMC providers regarding documentation regulations and chart audit findings.</p>
</li></ul>
<ul><li><p>Maintains confidentiality of all accessible patient financial or medical records information.</p>
</li></ul>
<ul><li><p>Demonstrates the awareness of the importance of cost containment for the department. Provide suggestions regarding process or quality improvement opportunities to department manager.</p>
</li></ul>
<ul><li><p>Other duties as assigned to facilitate accurate, timely patient account management.</p>
</li></ul>
</div><p></p><p>Date Created: 5/18, updated 7/22</p>
<p>
Grade: NC11</p>
<p>
FLSA: E</p>
<p>
Cost Center: 8490</p><br>
<p><b>
Job Qualifications:</b></p>
<p>PREREQUISITES:</p>
<div>
<ul><li><p>Current unrestricted WA State Registered Nurse license, required.</p>
</li></ul>
<ul><li><p>Bachelor's degree in Nursing, preferred.</p>
</li></ul>
<ul><li><p>Minimum five years recent clinical experience as an RN working in an acute care setting or with experience in Utilization Review</p>
</li></ul>
<ul><li><p>Pass a pre-hire Clinical Exam with a minimum score of 70%</p>
</li></ul>
<ul><li><p>Effective communication with Providers</p>
</li></ul>
</div><p></p><p>QUALIFICATIONS:</p>
<div>
<ul><li><p>Knowledge of hospital clinical practice standards for physicians and other health care providers.</p>
</li></ul>
<ul><li><p>Knowledge of ancillary service departments, quality control and safety standards.</p>
</li></ul>
<ul><li><p>Critical thinking, problem solving and deductive reasoning skills.</p>
</li></ul>
<ul><li><p>Familiarity with health care audit and research design.</p>
</li></ul>
<ul><li><p>Knowledge of Pathophysiology and Disease process.</p>
</li></ul>
<ul><li><p>Functional knowledge of DRG coding systems.</p>
</li></ul>
<ul><li><p>Working experience with Utilization Review activities and general knowledge of JCAHO, PRO, HCFA, and other regulatory bodies.</p>
</li></ul>
<ul><li><p>Knowledge of third-party payer review, reimbursement systems and utilization monitoring requirements for acute care facilities.</p>
</li></ul>
<ul><li><p>Meet productivity guidelines.</p>
</li></ul>
<ul><li><p>Ability to learn/develop the skills necessary to perform and meet goal standards</p>
</li></ul>
<ul><li><p>Organizational, analytical, writing, and interpersonal skills</p>
</li></ul>
<ul><li><p>Dependable, self-directed, and pleasant</p>
</li></ul>
<ul><li><p>Critical thinking, problem solving and deductive reasoning skills</p>
</li></ul>
<ul><li><p>Knowledge of Pathophysiology and Disease Process</p>
</li></ul>
<ul><li><p>Basic Computer skills - familiarity with Windows based software programs</p>
</li></ul>
<ul><li><p>Knowledge of regulatory environment</p>
</li></ul>
<ul><li><p>Understand and support documentation strategies (upon completion of training)</p>
</li></ul>
<ul><li><p>Knowledge of Core Measure and Patient Safety Indicators (upon completion of training)</p></li></ul></div></div><p></p>

Clinical Documentation Specialist

Regeneron

<div>
 Clinical Study Specialist- R46129
 <br/>
 <br/>
 <strong>
  Position Description
  <br/>
  <br/>
 </strong>
 The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
 <br/>
 <br/>
 <strong>
  Roles Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Organizes and delivers analyzable reports and metrics to the clinical study lead
  </li>
  <li>
   Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
  </li>
  <li>
   Collates data for assessments such as feasibility and site selection and reviews site usability database
  </li>
  <li>
   Contributes to review of study documents such as informed consent forms, case report forms
  </li>
  <li>
   Facilitates study document reviews per company standard operating procedures
  </li>
  <li>
   Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
  </li>
  <li>
   Collates materials for training and investigator meetings
  </li>
  <li>
   Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
  </li>
  <li>
   Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
  </li>
  <li>
   Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
  </li>
  <li>
   Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form)
  </li>
  <li>
   Manages and maintains team SharePoint and/or shared drive sites, as needed
  </li>
  <li>
   Communication with sites as directed and maintains site contact information
  </li>
  <li>
   Contributes to line listings review for Blind Data Review Meeting (BDRM)
  </li>
  <li>
   May manage or contribute to oversight of Third-Party Vendors (TPV)
  </li>
  <li>
   Tracks and monitors close out activities ? study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
  </li>
  <li>
   Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
  </li>
  <li>
   Proactively recommends process improvement initiatives for the department
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Attention to details for the ability to track information and deliver on assigned study activities
  </li>
  <li>
   Good communication and interpersonal skills; ability to build relationships internally and externally
  </li>
  <li>
   Ability to be resourceful and to demonstrate problem solving skills
  </li>
  <li>
   Demonstrate the ability to proactively assess information and investigate impact on clinical trials
  </li>
  <li>
   Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
  </li>
  <li>
   Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
  </li>
  <li>
   Basic familiarity with medical terms and clinical drug development
  </li>
  <li>
   Awareness of ICH/GCP
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education &amp; Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Minimum of a Bachelor's degree
  </li>
  <li>
   2 years? industry related work experience in a clinical setting
  </li>
 </ul>
</div>


Temp - Clinical Study Specialist

UniTriTeam

<div><p><b>EDC Data Entry Specialist (Remote &ndash; </b><b>PST/CST/EST Hours)</b></p><br>
<p></p>
<p><b>
Company:</b><br>
UniTriTeam &ndash; Supporting Clinical Research Excellence</p>
<p><b>
About the Role</b><br>
UniTriTeam is hiring for multiple <b>remote EDC Data Entry Specialist roles</b> to support our clinical research clients across the U.S. These full-time remote positions require availability during standard business hours in <b>Pacific (PST), Central (CST), or Eastern (EST)</b> time zones.</p>
<p>
We're looking for meticulous, detail-oriented professionals with a medical background and a passion for data accuracy. In this role, you'll be responsible for entering and verifying clinical trial data in EDC systems, maintaining the highest standards of data integrity.</p>
<p><b>
Key Responsibilities</b></p>
<ul>
<li>Accurately enter clinical trial data into Electronic Data Capture (EDC) systems in compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.</li>
<li>Perform validation and quality checks to ensure data completeness and accuracy.</li>
<li>Work collaboratively with clinical research coordinators and site staff to resolve discrepancies.</li>
<li>Maintain strict confidentiality and security of all clinical trial data.</li>
<li>Generate data reports and summaries for site and study team review as needed.</li>
<li>Keep current on all study-related documents and database/system updates.</li>
<li>Complete all study-required trainings as instructed by the clinical research site team.</li>
<li>Follow all Standard Operating Procedures (SOPs) and suggest improvements to optimize workflows.</li>
</ul>
<p><b>Required Qualifications</b></p>
<ul>
<li><b>Education &amp; Experience</b></li>
<li><ul><li>Medical background (degree or relevant professional experience) is required.</li>
<li>Prior data entry experience in clinical research or healthcare is highly preferred.</li>
</ul></li><li><b>Technical Skills</b></li>
<li><ul><li>Experience with EDC platforms such as Medidata RAVE, REDCap, or similar systems is highly preferred.</li>
<li>Proficiency with Microsoft Office Suite (Word, Excel, Outlook).</li>
</ul></li><li><b>Core Competencies</b></li>
<li><ul><li>Excellent attention to detail and high degree of accuracy.</li>
<li>Ability to work under tight deadlines in a regulated environment.</li>
<li>Effective communication skills and a collaborative spirit.</li>
<li>Familiarity with clinical trial processes and medical terminology is a plus.</li>
</ul></li>
</ul><p><b>Why Join Us?</b><br>
UniTriTeam is a global leader in providing operational, administrative, and technology support to clinical research sites. We take pride in our mission to help advance medicine and make a real impact in healthcare. By joining our team, you'll benefit from:</p>
<ul>
<li>A collaborative and supportive work environment</li>
<li>Opportunities for professional growth and advancement</li>
<li>A chance to be part of meaningful research initiatives that change lives</li></ul></div>

EDC Data Entry Specialist

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