This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Documentation Specialist enhances the overall quality and accuracy of clinical documentation on a concurrent and retrospective basis through daily review and interactions with physicians and healthcare providers. They utilize clinical and coding expertise to analyze documentation, ensuring it accurately reflects the level of service provided. This role supports timely and precise capture of quality metrics to improve patient care, physician documentation, and hospital outcomes. - Perform daily review of clinical documentation and interact with physicians and providers to ensure completeness and accuracy. - Analyze and evaluate documentation to ensure it reflects appropriate levels of care and supports quality measures. - Support timely coding and documentation processes to optimize hospital and physician performance metrics. - Collaborate with clinical teams to identify documentation gaps and implement improvement strategies. - Stay current with coding guidelines, documentation standards, and quality measurement requirements. - Maintain compliance with regulatory and accreditation standards related to clinical documentation. - Support education and training initiatives for staff regarding documentation best practices. - Utilize clinical and coding expertise to support continuous quality improvement initiatives. Qualifications - Associate’s Degree required; Bachelor's Degree preferred. - 0-3 years of relevant experience in clinical documentation, coding, or related fields. - Active Registered Nurse (RN) license in Indiana or Nurse Licensure Compact (NLC) RN license, or RHIA/RHIT and/or CCS certification. - If RN licensed, 3-5 years of strong, varied clinical experience in an acute care setting preferred. - CCDS and/or CDIP credential preferred; obtain within 4 years of hire. - Ability to work independently and produce high-quality outcomes. - Working knowledge of computers and software applications such as Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, SharePoint, Teams) and Cerner EMR. - Ability to sit for extended periods. - Position is remote but may require occasional on-site meetings with advanced notice. Benefits - Comprehensive benefits package including health, dental, and vision insurance - Retirement savings plan with employer match - Tuition reimbursement and professional development opportunities - Employee assistance programs and wellness initiatives - Supportive work environment committed to safety and excellence

About Blackbird Health Blackbird Health is clinician-founded, owned, and operated by dedicated professionals. We believe that providing the best care for children starts with building the best possible team. We deliver virtual and in-person mental health services across Pennsylvania, Virginia, and New Jersey—and we’re growing into new markets in 2026. At Blackbird, we take a whole-child approach, looking at how the brain, body, and behavior interact to address the root causes of challenges, not just the symptoms. Every role matters here, and you’ll join a collaborative, supportive, and innovative team that’s shaping the future of pediatric mental health care. If you’re passionate about helping children and families while growing your career, Blackbird is the place to make an impact. Join us and help change mental health care for children for the better! Join our Talent Network! Interested in joining Blackbird Health but don’t see the perfect role listed right now? We’d still love to connect. Submit your information to join our Talent Network and be considered for future opportunities. We're continuously growing our team of clinicians. We are hiring for W2 and 1099 clinicians, both provisionally and fully licensed across multiple locations in Pennsylvania, Virginia, Maryland and New Jersey. What We're Looking For: We hire Social Workers (LSW, LCSW, SiSW, LMSW), Licensed Professional Counselors (LPC), Licensed Marriage and Family Therapists (LMFT), and other mental health clinicians with experience working with children and adolescents. Opportunities include: - W2 full-time and part-time positions - 1099 contract roles - Virtual and in-person locations across PA, VA, MD, and NJ Why Blackbird? - Guaranteed caseload from day one - Flexible scheduling - Full credentialing support - Weekly paid clinical consultations - Competitive compensation and benefits - Career growth opportunities The Blackbird Talent Network Submit your application below and our team will be in touch. By applying, you agree to receive communications from Blackbird about current and future opportunities that may align with your experience. Join us! To raise the standard of pediatric mental health care through accurate understanding and precise treatment that reflect how each child’s brain, body, and behavior work together. “It's so rare to find comprehensive care like this---from testing to therapy to med management (and more)--all in one place. In addition, the school advocacy support we receive is unprecedented. We no longer feel like we are managing things alone.” Fostering an inclusive environment: Blackbird is committed to cultivating and preserving a culture of inclusion and belonging. We are able to grow and learn better together with a diverse team of employees. In recruiting for our team, we welcome the unique contributions that you can bring in terms of your education, opinions, culture, ethnicity, race, sex, gender identity and expression, nation of origin, age, languages spoken, veteran status, color, religion, disability, sexual orientation and beliefs. Blackbird provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type. If you need a reasonable accommodation during the application or interview process, please contact us at recruiting@blackbirdhealth.com so we can support you. Our patient support team is busy helping children and families, please do not call or email them about your application — this helps us process your application more efficiently.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Position Summary: The Clinical Research Associate/Clinical Research Monitor (CRA) plays a key role in the quality oversight and regulatory integrity of a large, high-profile, multi-center NIH-funded stroke outcomes study enrolling and following 8,000 participants across 20 U.S. sites. The CRA is responsible not only for conducting risk-based monitoring activities in accordance with ICH-GCP guidelines, federal regulations, study SOPs and the approved monitoring plan, but also for contributing to the ongoing refinement of the study’s quality oversight strategy. This includes proactively evaluating site performance trends, identifying emerging risks, and recommending monitoring and quality control adaptations aligned with the study’s lifecycle (startup, peak recruitment, retention-focused follow-up, and close-out). This role requires advanced clinical research expertise, strong regulatory knowledge, independent judgment, and the ability to partner closely with study leadership to ensure participant safety, data integrity, and operational excellence across a complex, multi-site network. Qualifications Competencies Required: - Excellent oral and written communication skills - Strong interpersonal and relationship-building skills with investigators and site staff - Ability to work independently with a high degree of accountability - Ability to travel up to 10% of the time for meetings and on-site monitoring visits - Ability to identify operational, regulatory, or quality risks and develop strategic, solution-oriented recommendations - Exceptional attention to detail and strong organizational skills - Proficiency navigating and utilizing multiple online systems and software platforms - Advanced knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections - Ability to analyze performance metrics and develop and implement risk-based quality management strategies Primary Duties: - Conduct site monitoring visits (including Site Qualification Visits, Site Initiation Visits, Monitoring Visits, and Close-Out Visits) in accordance with the approved monitoring plan. - Exercise partial ownership of the study’s quality oversight framework by evaluating the effectiveness of the existing monitoring plan and recommending strategic revisions based on study phase, enrollment status, retention priorities, protocol amendments, monitoring findings, and site performance trends. - Collaborate with study leadership to implement adaptive monitoring approaches, including modifications to visit frequency, scope of review, central versus on-site monitoring balance, and targeted risk mitigation strategies. - Assess site compliance with the study protocol, informed consent requirements, IRB approvals, and regulatory obligations, ensuring protection of participant rights and safety. - Perform source data verification and source document review to ensure that data entered into electronic case report forms (eCRFs) are accurate, complete, and verifiable from source documentation. - Identify systemic data quality trends or recurring compliance issues and provide recommendations for corrective and preventive actions (CAPA) at both the site and study-wide levels. - Review and assess essential regulatory documents, including IRB documentation, delegation logs, training logs, and protocol deviation logs - Ensure timely resolution of data queries and protocol deviations in collaboration with site personnel and the Coordinating Center. - Provide study-specific training to investigators and site staff throughout the study lifecycle, reinforcing protocol adherence and regulatory best practices. - Maintain regular communication with sites to support enrollment, data quality, retention efforts, and adherence to study procedures. - Document monitoring activities, findings, and follow-up actions through detailed monitoring reports and formal correspondence within established timelines. - Report significant findings, trends, or compliance concerns to study leadership and contribute to action planning discussions. - Participate in weekly study team meetings and actively contribute to discussions regarding site performance metrics, quality indicators, and strategic oversight planning. Other Tasks, as required: - Participate in site and/or investigator selection processes, providing input regarding site readiness and risk profile. - Contribute to the development and refinement of monitoring tools, risk assessment frameworks, tracking systems, and quality improvement initiatives. - Perform central monitoring activities, including analysis of recruitment trends, retention metrics, protocol deviation patterns, and data quality dashboards. - Support preparation for sponsor reviews or regulatory inspections, including documentation review and corrective action planning. - Attend and participate in investigator meetings, coordinator meetings, and study training sessions as needed. - Submit monitoring visit expense reports and administrative documentation in a timely manner. Education - BA or BS required. Clinical research professional certification preferred (e.g., ACRP, SOCRA). Experience - Minimum of 2 years of experience in clinical research; 3–5 years preferred with a minimum of 1 year of monitoring experience. - Experience in multi-center clinical trials and/or stroke, neurology, or outcomes research preferred. - Demonstrated knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections. - Experience contributing to risk-based monitoring strategies or quality oversight initiatives preferred. - Proficiency with Microsoft Office applications and clinical research data management systems. - Demonstrated ability to manage monitoring responsibilities across multiple sites. Knowledge, Skills and Abilities - Ability to work independently and as a team member. - Strong attention to detail and organizational skills. - Knowledge of clinical research protocols. - Knowledge of data management programs. - Computer literacy. - Knowledge of clinical trials, research, and general medicine. Additional Job Details (if applicable) Physical Requirements - Standing Frequently (34-66%) - Walking Frequently (34-66%) - Sitting Occasionally (3-33%) - Lifting Frequently (34-66%) 35lbs+ (w/assisted device) - Carrying Frequently (34-66%) 20lbs - 35lbs - Pushing Occasionally (3-33%) - Pulling Occasionally (3-33%) - Climbing Rarely (Less than 2%) - Balancing Frequently (34-66%) - Stooping Occasionally (3-33%) - Kneeling Occasionally (3-33%) - Crouching Occasionally (3-33%) - Crawling Rarely (Less than 2%) - Reaching Frequently (34-66%) - Gross Manipulation (Handling) Frequently (34-66%) - Fine Manipulation (Fingering) Frequently (34-66%) - Feeling Constantly (67-100%) - Foot Use Rarely (Less than 2%) - Vision - Far Constantly (67-100%) - Vision - Near Constantly (67-100%) - Talking Constantly (67-100%) - Hearing Constantly (67-100%) Remote Type Remote Work Location 175 Cambridge Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $50,502.40 - $82,014.40/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential • investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Education and Experience Requirements: • Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions