• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget • Leads the regional clinical operations team and acts as point of escalation for resolution of issues within the region for the assigned study • Ensures alignment of regional deliverables with overall study goals • Manages the trial data collection process for the region, drives data entry and query resolution

Role Description The Clinical Specialist II abstracts and enters clinical data in an accurate and timely manner from all available sources to provide the required data elements to various web-based venues. Learns and understands databases and terminology staying current on definitions/terminology changes, educating others as appropriate on process/terminology changes. Coordinates with the appropriate personnel to ensure all data elements are recorded, and performs validation for the components of the data collection process. Works to continually improve accuracy of data elements and prepares appropriate reports as required. - Collects accurate data from optical imaging and the actual patient record, to provide valid and reliable patient information in accordance with the published standards. Qualifications - Associate’s degree in Nursing - FL RN License - Five (5) years experience interpreting medical documentation relative to abstraction standards using defined algorithms and rule sets or three (3) years clinical experience. - Advanced computer skills including Outlook, Word, Excel and PowerPoint or similar office productivity software. - Knowledge of medical terminology Requirements - Reviews, abstracts, enters and analyzes clinical and administrative data for moderately complex abstraction tasks (Get with the Guidelines or similar) as assigned. - Collects accurate data from all available sources in accordance with current guidelines. - Maintains documentation and knowledge of current edition of guidelines for relevant data collection systems. - Utilizes critical thinking, problem-solving and process improvement concepts to create an efficient work environment. - Communicates effectively with stakeholders regarding data quality, fallouts and current definitions/standards. - Analyzes aggregated data to identify opportunities for improvement, report outcomes and facilitate decision making by clinical improvement teams. - Uses basic statistical techniques for data analysis. - Assembles, analyzes & presents complex reports for regulatory agencies and internal quality improvement purposes according to department guidelines. - Maintains current knowledge of medical terminology sufficient to interpret the medical record for accurate abstraction. - Demonstrates responsibility for effective time management including ability to reprioritize as directed independently under general supervision with latitude for initiative and independent judgment. - Cross-trains to assist with multiple systems as necessary. - Trains new team members on a variety of systems to ensure compliance, data integrity, and prevent breaches of protected health information (PHI). - Functions as a resource to Orlando Health in the area of healthcare regulations, standards of care, and clinical performance improvement. - Works collaboratively with Clinical Practice Improvement personnel, HIM, various Clinical Nurse Specialists, Unit Based Educators, and Information Systems staff as appropriate. - Maintains working knowledge of quality improvement philosophy, methodologies, and applications as appropriate. - Maintains current knowledge of The Joint Commission standards related to Quality Improvement. - Assists in documentation for and presents data to The Joint Commission and other accreditation/regulatory bodies as assigned. - Maintains clinical information accuracy rate in accordance with the published standards including quarterly testing for data integrity (must maintain accuracy of 95% or greater). - Informs direct leader of quality issues/concerns. - Demonstrates excellent communication skills with all team members. - Provides feedback to leader regarding accuracy and usefulness of data collection systems as requested. - Assists in design and validation of dashboards as a subject matter expert. - Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards. - Maintains compliance with all Orlando Health policies and procedures.

Title: Clinical Research Coordinator Location: Charlestown, United States Part time job requisition id RQ4062793 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 GENERAL SUMMARY/OVERVIEW STATEMENT: The Department of Psychiatry at MGH seeks a per diem Clinical Research Coordinator (CRC) to work on ongoing studies of adults from a longitudinal cohort, with and without psychiatric disorders. The projects focus on the roles of hormones and genes in the understanding of sex differences in brain circuitry implicated in psychiatric disorders, disorders of aging in the brain, and their comorbidity with general medical disorders. The CRC will work within the Clinical Neuroscience Laboratory of Sex Differences in the Brain, part of the Innovation Center on Sex Differences in Medicine. One of our foci is to investigate early risk factors for sex differences in psychiatric disorders focusing on the roles of hormones, genes, and inflammatory factors in understanding sex effects in depression and its comorbidity with cardiometabolic outcomes. We conduct structural and functional brain imaging studies, combined with neuroendocrine evaluations, psychophysiology, and genetics. We work within a team approach. A key element of this position involves contact with human research participants (adults in midlife), so candidates should enjoy and feel comfortable interacting with various populations. Qualifications PRINCIPAL DUTIES AND RESPONSIBILITIES: · Collects & organizes patient data · Maintains records and databases · Assists with scheduling subjects for testing sessions · Obtains study subject data from databases, etc. · Verifies accuracy of study forms · Updates study forms per protocol · Documents subject visits and procedures · Assists with QA/QC procedures · Interviews study subjects/conducts cognitive testing session · Administers and scores questionnaires · Provides basic explanation of study and in some cases obtains informed consent from subjects · Performs study procedures · Performs administrative support duties as required · Maintain research data and study databases · Perform data analysis and QA/QC data checks · Organize and interpret data · Act as a study resource for study subject · Evaluate study questionnaires · Contribute to protocol recommendations SKILLS/ABILITIES/COMPETENCIES REQUIRED: · Careful attention to details · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols · Ability to demonstrate respect and professionalism for subjects’ rights and individual needs · Ability to work independently and as a team player · Analytical skills and ability to resolve technical problems · Ability to interpret acceptability of data results · Working knowledge of data management program EDUCATION: Bachelor’s degree required. Must have background/knowledge of neuroscience/neurobiology, psychology, or related field. EXPERIENCE: Preferred: Experience in an academic/research setting; work with human research subjects or with adult population in a service field. Prior cognitive testing experience highly preferred. Additional Job Details (if applicable) Remote Type Onsite Work Location 149 Thirteenth Street Building 149 Scheduled Weekly Hours 0 Employee Type Per Diem Work Shift Day (United States of America) Pay Range $20.16 - $29.01/Hourly Grade 5 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.

• Accountable for the trial activities for responsible R/OPU • Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations • Creation, management and review of the R/OPU trial budget • Timely budget updates based on trial changes • Appropriate trial-specific training of R/OPU internal and external partners • Verifies and provides input into the country and site level feasibility • Finalize and validate site selection • Development and implementation of country level engagement plans • Coordinating development of country level patient facing documents • Ensure timely responses to questions from Regulatory Authority/Ethics Committee • Maintains oversight during clinical trial conduct • Monitor progress of patient recruitment endpoints • Establish and maintain relationships with external experts, investigational sites, etc.