Clinical Research Coordinator Jobs in Kemp Mill, MD

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACLC (T3) Job Family: Scientists Job Qualifications: Skills: Clinical Research, Publishing, Traumatic Brain Injury (TBI) Certifications: None Experience: 3 + years of related experience US Citizenship Required: No Job Description: GDIT's Military Health Team is hiring a Sr. Clinical Research Director to lead a research team for the Traumatic Brain Injury Center of Excellence (TBI CoE) located at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, MD. As the traumatic brain injury (TBI) Pathway of Care manager within the Military Health System (MHS), TBICoE promotes state-of-the-science care from point-of-injury to reintegration for Service members, veterans, and their families to prevent and mitigate consequences of mild to severe TBI. TBICoE unifies a system of TBI health care, reliably advancing the science for the warfighter and ready to meet future brain health challenges. Learn More here --> Traumatic Brain Injury Center of Excellence | Health.mil **Position available May/ June 2025** Work visa sponsorship will not be considered for this position. SUMMARY: S/he provides leadership to ensure all operations support clinical research investigations and, where applicable, patient care support that are mapped to known TBI gaps and priorities and will comply with all Command, federal, state, regulatory, TBICoE and contractor requirements. Clinical functions will not take more than twenty percent of the work week and will be in support of the clinical research at the site. HOW YOU WILL MAKE AN IMPACT: Leads, supports and provides oversight of research related activities and contract staff at the local TBICoE site and across TBICoE's clinical research network. May serve as a Principal/Associate Investigator. Ensures clinical research projects are delivered on time, on budget and to the agreed quality standard. Develops, implements and maintains partnership with patients, other health care providers, researchers and community resources as applicable. Abides by all applicable regulations with regard to Utilization Review and Quality Improvement directives including, but not limited to, in-service training, peer review, performance /project/ program improvement initiatives, records maintenance, performance evaluations and release of information. Attends and presents at conferences, meetings, trainings for professional development and presentation of research findings, as appropriate. Oversees the design and execution of clinical research initiatives to include development of grant proposals and new TBI research studies in alignment with TBICoE research gaps and priorities at their site as well as ensuring compliance with all regulatory bodies. In collaboration with TBICoE leadership and site director, develops metrics for a successful site clinical research program and tasks related to TBICoE's mission. Supports TBI research through development and implementation of research studies in collaboration with research professionals locally, nationally and internationally. Prepares requests for actions/proposals to include assisting with grant proposal applications, their associated documentations and requirements. Facilitates the flow and approval processes for relevant projects as needed or requested. Ensures effective communication and knowledge sharing with TBICoE research colleagues and scientific team. Contributes to the preparation of research manuscripts for publication in the area of TBI and presentation of posters and papers at scientific meetings. Serves as a liaison between TBICoE nationally, locally and the Command. Provides assistance and expertise to TBICoE senior leadership in issues of TBI research, clinical care and standards of care for patients along the full continuum of TBI severity. Provides assistance and expertise to TBICoE leadership in responding to “taskers”, drafts of EXSUMS and Information Papers, attendance at meetings such as R&As, IPRs, reviews of research proposals. Collaborates with Program Manager and monitors contract program activities (e.g. staff training and performance; recruitment and hiring; and planning). Adhere to legal, professional and ethical codes with respect to confidentiality and privacy. Other duties consistent with the above responsibilities position requirements What You'll Need (required): MD, PhD, MD/PhD, or relevant terminal doctorate degree in related health or medical field (Experience within clinically appropriate systems of care may be accepted in lieu of educational minimums). 5+ years of training or experience in clinical and/or research activities in traumatic brain injury required. 5+ years of experience in research as demonstrated by peer reviewed publications and presentations required. Ability to facilitate, present and translate information to diverse end users of research findings in small and large groups, inclusive of providers, scientists, line leaders and other relevant TBI stakeholders, as well as the flexibility to re- prioritize quickly required. Must have a high level of competence in clinical investigations, administration and education. Knowledge and experience with military health system, combat/deployment issues, and psychological health issues in the military are highly desired. Ability to work as part of a multidisciplinary health care team is required. Ability to work comfortably with computer software, including Microsoft Word, Excel, Outlook and PowerPoint. Must complete CITI/ HIPAA training. Ability to pass a T3/ NACLC security investigation. What Would Be Even Better (highly preferred): Prior experience within the DoD/VA systems of care preferred. 2+ years management experience preferred. Attributes for Success: Ability to function independently with a high degree of professionalism and clinical judgment required. Excellent interpersonal skills with the ability to interact with staff at all levels to foster collaborative research activities required. Excellent oral and written communication skills required. #MilitaryHealthGDITJobs #GDITFedHealthJobs #GDITClinicalResearchJobs The likely salary range for this position is $146,200 - $197,800. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: None Telecommuting Options: Hybrid Work Location: USA MD Bethesda Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation's most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.GDIT is an Equal Opportunity/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, or veteran status, or any other protected class.

Catalyst Life Sciences is currently partnered with a global medical research organization for their oncology clinical research division based in the Baltimore, MD area. Day to day you will: Design and manage a project by monitoring timelines, budgets and other considerations Coordinate with lead scientists, business developers, other clinical trial managers and other technical staff Ensure trials are following governance by the approprate bodies and detailed record keeping of the trial To be successful you should have: Previous experience managing clinical trials or as a clinical research associate Experience working in the Oncology or Molecular Diagnostics/IVD space Experience working in a bench research

If you are physically/mentally ill or healthy, get paid to trial new treatments and medications. This is a great way to earn additional income, sometimes from the comfort of your home. Participation in clinical trials can be a very rewarding experience. Not only do you get free access to cutting-edge medical treatment, but you are also contributing to science all whilst getting paid. Some of the conditions we are currently recruiting for include: Healthy participants Migraines Mental Health Issues Alzheimer's Disease Parkinson's Skin Conditions/Eczema Cancer COPD Diabetes Crohn's Children with Autism ..and many more Compensation can be up to several thousand dollars depending on the trial. No experience or education required.

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Research Nurse to support the National Institutes of Health (NIH) in Bethesda, MD. This is an on-site position. This is a Full-Time long term contract position which offers: Competitive compensation and comprehensive benefit package Optional health, vision, and dental plans Paid leave (min 120 hours) as well as 11 paid federal holidays and 401K plan. Access to NIH's unparalleled resources and niche scientific initiatives. Learn more about what Kelly can do for you at ************************************ TASKS/SERVICES Recruit and follow patients for clinical and basic research studies on HIV vaccines and emerging/re-emerging vaccines. Review charts to collect relevant clinical data such as laboratory test results and social background. Interview patients to obtain medical history, sexual history, medication history, history of use of substances such as alcohol and recreational drugs, previous HIV related risks factors and history of participation in other clinical research. Interpret data, responsible for recognizing results that merit prompt clinical action. - Perform physical assessments of patients, analyzes trends in patient conditions, and suggests possible alterations in treatment regimens according to research protocols. Perform protocol activities such as, study drug administration, data collection and submission, patient counseling, and physical assessment. Interpret clinical data in terms which may be understood by the patient, as well as, interpretation at a level which is conversant with other health professional including physicians. Coordinate and ensure the collection of specimens needed for all studies on patients enrolled in vaccine studies. REQUIREMENTS Associate's or Bachelor's Degree in Nursing Documentation (licensure) of current, active, full, and unrestricted license or registration as a nurse in the state of Maryland.

Research Nurse Specialist Transplant and Cellular Therapy, Hematology The Division of Intramural Research conducts over 180 clinical trials spanning clinical areas such as hematology, cardiology, and cardiac imaging, pulmonary, sickle cell disease, and vascular medicine. We are seeking an exceptionally talented, knowledgeable, and motivated individual for a Research Nurse Specialist position to work in the transplant and cellular therapy arena. In this position, you will have a critical role in the various protocol development, implementation, and evaluation activities. You will also serve as a crucial part of a dynamic clinical team for several simultaneous research studies. Primary Duties: Educate and counsel patients participating in clinical trials, including, following up with patients in long-term studies and providing Q&A time via phone to patients. Work with a diverse team of health care providers, such as, physicians, advanced practitioners, patient care coordinators, and data managers to service patients and conduct clinical research. Facilitate patient recruitment and enrollment into ongoing clinical trials. Ensure compliance with protocol and regulatory requirements. Support ongoing research and clinical programs at NHLBI and NIH Clinical Center. Manage clinical research data and providing data quality assurance. Requires Skills/Background: Degree from a professional nursing program approved by the legally designated State accrediting agency at the time you completed the program. Active, current license as a registered nurse in the United States, the Commonwealth of Puerto Rico, or a territory of the United States. OR Recently graduated from an approved nursing educational program within the past 12 months and your registration is pending. Nursing Experience: Required: at least 2 years of experience in transplant, hematology/oncology Preferred: clinical research experience Details: The role is located on the main NIH campus in Bethesda, Maryland and is bus/bicycle/metro accessible. Some additional details are: Employment type: contract, full-time (can be renewed indefinitely) Salary: commensurate with education and experience Benefits: competitive benefits available! Work Location: This position primarily requires an on-site presence at the NIH main campus in Bethesda, MD. Ad hoc telework opportunities may be considered based on team needs and organizational guidelines. Mandatory training needed to be successful in this position is offered and supported! We strongly encourage applications from Black, Indigenous, and People of Color (BIPOC), people who identify as LGBTQIA+ and non-binary, people living with disabilities, and people from marginalized communities. We are happy to talk further about steps we've taken to integrate Equity, Diversity, and Inclusion values into our workplace.

**Join the HJF Team!** HJF is seeking an **Assistant Study Coordinator** to assist with routine and non-routine research support for the department/division to enhance operating efficiency; responsible for data collection. This is the lowest of three levels within the Study Coordinator series. This position will be in support of the Military Traumatic Brain Injury Initiative. Rapid detection of brain bleeding is critical to a patient's outcome. Unfortunately, in remote or austere environments, first responder medical providers are limited as to the sophisticated medical devices necessary to address this type of head trauma. The overarching goal of this team is to develop, validate, and ultimately deliver critical tools to first responders so that they may detect, determine severity of, and treat an acute hematoma on the brain. This study team has made important progress with respect to developing an optical device for detection of brain hemorrhage that may allow the patient to achieve a more favorable outcome post trauma. Experiments will be undertaken to artificially induce a life-threatening level of blood accumulation underneath the skull but above the brain in a large animal model (sheep), and test the effectiveness of the detection device in the hands of medical operators who have similar skills and training as military medical first responders. The operators will not know in advance whether the animals do or do not have brain bleeding. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals. Responsibilities * Operates novel Intracranial Hemorrhage Detection Device (IHDD) as instructed by study staff in a laboratory setting. * May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role. Qualifications **Education and Experience** * High school diploma or GED required. Associate's Degree preferred. * Minimum of 0-2 years experience required. **Required Knowledge, Skills and Abilities** * Communicates effectively. * Willingness to work with sheep. * Experience as a special operations medic/corpsmen. **Physical Capabilities** * Lifting: Requires lifting materials up to 10 lbs. * Ability to stand or sit for prolonged periods. **Work Environment** * This position will take place primarily in an office setting. * **This is a temporary part time position, working 4 hours per week for 14-20 weeks.** **Compensation:** * The hourly pay range for this position is $20.98-$33.87. Actual salary pay will be determined based on experience, education, etc. **Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.** Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. **Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities** The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) *Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.*

University of Maryland, Baltimore Location: Baltimore, Maryland Type: Non-Remote Posted on: November 26, 2024 Submission for the position: Clinical Research Scientist - (Job Number: 240001QD) Clinical Research Scientist Division of Psychiatric Services Research, Department of Psychiatry University of Maryland School of Medicine T he Division of Psychiatric Services Research (DPSR) in the Department of Psychiatry at the University of Maryland School of Medicine (UMSOM) at the University of Maryland Baltimore (UMB) is recruiting a Clinical Research Scientist who will build on our existing applied clinical research, evaluation, training, and dissemination aimed at improving the quality and outcomes of care for persons with mental health and substance use disorders. The mission of DPSR is to contribute to the evidence base for safe and effective interventions for improving mental health outcomes and enhancing recovery, evaluate the best settings and circumstances for offering interventions, and promote implementation of effective interventions through training and dissemination. We encourage applications in all areas of health services research and are particularly interested in individuals with expertise, skills and experience in one or more of the following content and methodological areas. Priority Content Areas · Improving access to evidence-based interventions for affective disorders including treatment resistant depression · Design, testing, and/or implementation of physical health and mental health services to improve women's mental health across the lifespan · Services research at the intersection of serious mental illness and disorders of aging Priority Methodological Areas · Implementation science · Big data mining and analytics · Community-based participatory research Our division ( Division of Psychiatric Services Research | University of Maryland School of Medicine (umaryland.edu) and department, which is home to the Maryland Psychiatric Research Center ( Maryland Psychiatric Research Center (MPRC) | University of Maryland School of Medicine (umaryland.edu) , have a long and rich history of health services research. Our division is the academic affiliate for the VA Capitol Healthcare (VISN 5) Mental Illness Research, Education, and Clinical Center ( VISN 5 MIRECC - Putting Recovery Into Practice - MIRECC / CoE (va.gov) , a VA center of excellence in health services research in serious mental illness and mental health recovery. Campus wide initiatives in translational addictions research ( Kahlert Institute for Addiction Medicine | University of Maryland School of Medicine (umaryland.edu) , research using large-scale medical records data [ The University of Maryland Institute for Health Computing - MPower Maryland ] and translational neuroscience research [ University of Maryland - Medicine Institute for Neuroscience Discovery (UM-MIND) | University of Maryland School of Medicine (umaryland.edu) ] make our division an excellent place for creative and cutting edge services research. Resources for research career development ( Research Career Development | University of Maryland School of Medicine (umaryland.edu) ), medical record data access to support translational research ( UMB ICTR - University of Maryland, Baltimore (umaryland.edu) ), and community engaged research ( The PATIENTS Program (umaryland.edu) ) are available and accessible to enhance research programs in creative and diverse ways. This position represents a unique opportunity to relocate or develop an innovative and interdisciplinary health services research program that will be competitive for the full spectrum of federal, state, and foundation funding opportunities. The University of Maryland, Baltimore and UMSOM are equal opportunity/affirmative action employers. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. We are an inclusive work environment, and value diversity and how it enriches our academic and scientific community. The Department of Psychiatry is committed to actively examining, identifying, and addressing systemic racism and structural inequality, and agrees to an ongoing commitment of re-creating and improving the department culture as it relates to diversity, equity, and inclusion. Our priorities include establishing processes that will lead to long term sustainable gains in both faculty and staff recruitment and retention, increasing diverse representation in leadership positions for both faculty and staff, and continuing the work of improving the climate of inclusivity. We are committed to learning, healing, and growing together. Applicants must have a doctoral degree. Competitive candidates will have an established research record, reflected by a strong publication profile, existing extramural funding, and a track record of successful research funding and scientific productivity. Their areas of interest and expertise should complement established research programs in DPSR and they should be able to collaborate with clinical treatment and translational programs within the department and broader university. In addition to working within a highly collaborative research environment, the successful applicant also will be expected to participate in the educational and service missions of the department and UMSOM including contributing to psychology and psychiatry research training and career development programs and initiatives. Candidates from underrepresented groups and diverse backgrounds are strongly encouraged to apply. Academic rank, tenure-track status, start-up package, and salary will be commensurate with qualifications and experience. Expected rank is Assistant Professor or higher; however, rank and tenure status is dependent on candidate's qualifications. Questions may be directed to the Search Committee Chair, Dr. Melanie Bennett, at ************************** . School of Medicine - Clinical Departments Nov 26, 2024

We are actively recruiting for a Clinical Research Coordinator III to join our cardiology research team with MedStar Health Research Institute onsite at MedStar Union Memorial Hospital in Baltimore, Maryland. Under the guidance of the Clinical Trial Manager, the Clinical Research Coordinator (CRC) III functions independently and proficiently with minimal oversight and is responsible for the complete coordination of assigned clinical research activities of all phases and all levels of complexity, including investigator-initiated or other high profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and supports less experienced staff. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable. Primary Duties and Responsibilities Oversees, prepares, submits and maintains all regulatory submissions (e.g., new studies, annual review, amendments) accurately and within a timely manner; periodically self-audits records to ensure audit-readiness; ensures the appropriate delegation of study related tasks (i.e., Delegation of Authority).Oversees the informed consent process and reviews consent form with research participants and provides time for research participant to consider study participation; executes the informed consent process according to Good Clinical Practices (GCPs), procedures and other applicable rules, regulations and policies; educates new staff and research participates about protocol expectations and the conduct of clinical trials.Attends investigator meetings as required or as requested by the investigator and assists the investigator in communication of study requirements to all individuals involved in the study and provides appropriate training for study teams members.Optimizes the safety of research participants by monitoring and reporting any non-serious or serious adverse events to the investigators and other members of the study team.Generates, designs and makes recommendations to improve research participant recruitment and retention programs to study leadership; communicates challenges with recruitment and retention to study leadership. Minimum Qualifications Education * Bachelor's degree or an allied health or related professional degree and equivalent work experience required Experience * Experience as a clinical research coordinator in the clinical research field required * 3-4 years Clinical research or related experience required * Research and/or work experiences that demonstrate aptitude for research facilitation required Knowledge, Skills, and Abilities * Excellent verbal and written communication skills. * Strong communication and organizational skills. * Proficient computer skills. This position has a hiring range of $63,793 - $113,318

Baltimore, Maryland LMR Technical Group (LMR) is seeking a Community Brain Health Study Research Coordinator. Job Description: The Community Brain Health Study Research Coordinator will independently provide support services to satisfy the operational objectives of the Brain Health Equity (BHE) Unit within the Health Disparities Research Section (HDRS) at the National Institute on Aging (NIA). The primary objective is to provide services and deliverables by performing day to day management of a developing community-based cohort study under the direction of the Principal Investigator. Duties and Responsibilities: * Supports clinical staff develop, implement and maintain clinical research data files and materials. + Assist preparing and submitting for review accurate source documents related to all research procedures. + Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). + Participate in developing and maintaining research protocol documentation and operations. + Assist researchers with study testing, observations data entry and other duties associated with study sessions. * Collects research data and prepares information for inputs and analysis. + Verify study participant information and collect data and results of testing. + Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols. + Perform accurate and timely data analysis, report results and findings and respond to sponsor queries. + Set up, format and enter data into spreadsheets to analyze information and create reports. + Enter data into research databases, systems and applications for ongoing studies. * Supports the development of forms and questionnaires. + Assist researchers develop, maintain and complete study data collection forms and source documents. * Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests. + Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis. + Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts. + Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures. + Assist researchers with the collection and analysis of research data and samples. * Monitors subject's progress and reports adverse events. + Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc. + Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events. + Update and maintain logs and records of patient and family contacts. + Exhibit creativity in drafting newsletter, coordinating newsletter printing and distribution, and organize care package assembly. * Supports assembly, development and review of new research projects. + Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures. + Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures. + Assist researchers develop and maintain current and new research protocols. + Develop and nurture relationships with community stakeholders, such as religious leaders, community organizers, and local advocates, to build trust and engagement within the study's target population. This includes attending community meetings and events to promote the study and encourage enrollment. + Establish long-term partnerships with local organizations and institutions to ensure sustained community support and participant retention throughout the study. * Supports the creation and management of clinical websites and web-based tools. + Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system. * Organizes and performs clinical research, utilizing internet and other available clinical resources. + Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms. + Work with investigators to maintain Protocol Applications within the protocol management database system. + Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans. + Maintain and organize an online resource of documentation regarding clinical trials, including Standard Operating Procedure documents for all tasks related to the handling of clinical trials. * Provides assistance to staff in the collection, development and quality control of essential clinical research efforts. + Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. + Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry. + Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports. * Supports clinical staff develop, implement and maintain clinical research data files and materials. + Prepare and submit for review accurate source documents related to all research procedures. + Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). + Develop and maintain research protocol documentation and operations. + Assist researchers with study testing, observations data entry and other duties associated with study sessions. * Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices. + Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard * Operating Procedures and regulatory processes and considerations. + Organize, prepare and distribute informational materials and provide support to the educational mission of the study. + Researches changes and updates to Good Clinical Practices (GCP) and prepares summaries, job aids and training materials for research staff and new clinical research coordinators. + Mentor new clinical research coordinators on all aspects of research support. * Deliverables + Protocol Documentation: Work products related to the development and enforcement of study protocols. - Ad-Hoc + Compliance Reports: Documentation related to IRB compliance, including adverse event reporting and consent document updates. - Ad-Hoc + Operations Manual: A complete and up-to-date operations manual, along with records of updates and revisions. - Ad-Hoc + Community and Collaborator Engagement: Organize and develop partnerships with stakeholders across various sectors and different members of the community, including participants. - Weekly * Other related duties as assigned. Basic Qualifications: * Master's degree in public health, epidemiology, clinical research, or a related field, OR a bachelor's degree in community and public health, cognitive science and biopsychology, or neuroscience and equivalent specialized experience. * A mini

Position Objective: Provide services as a Community Brain Health Study Research Coordinator in support of the overall functions of National Institute on Aging within the National Institutes of Health (NIH). The contractor will independently provide support services to satisfy the operational objectives of the Brain Health Equity (BHE) Unit within the Health Disparities Research Section (HDRS) at the National Institute on Aging (NIA). The primary objective is to provide services and deliverables by performing day to-day management of a developing community-based cohort study under the direction of Dr. Indira Turney, the Principal Investigator. Duties and Responsibilities: * Assist preparing and submitting for review accurate source documents related to all research procedures. * Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). * Participate in developing and maintaining research protocol documentation and operations. * Assist researchers with study testing, observations data entry and other duties associated with study sessions. * Verify study participant information and collect data and results of testing. * Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols. * Perform accurate and timely data analysis, report results and findings and respond to sponsor queries. * Set up, format and enter data into spreadsheets to analyze information and create reports. * Enter data into research databases, systems and applications for ongoing studies. * Assist researchers develop, maintain and complete study data collection forms and source documents. * Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis. * Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts. * Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures. * Assist researchers with the collection and analysis of research data and samples. 5 * Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc. * Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events. * Update and maintain logs and records of patient and family contacts. * Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures. * Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures. * Assist researchers develop and maintain current and new research protocols. * Develop and nurture relationships with community stakeholders, such as religious leaders, community organizers, and local advocates, to build trust and engagement within the study's target population. This includes attending community meetings and events to promote the study and encourage enrollment. 1 * Establish long-term partnerships with local organizations and institutions to ensure sustained community support and participant retention throughout the study. 2 * Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system. * Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms. * Work with investigators to maintain Protocol Applications within the protocol management database system. * Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans. * Maintain and organize an online resource of documentation regarding clinical trials, including Standard Operating Procedure documents for all tasks related to the handling of clinical trials. * Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. 4 * Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry. 3 * Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports. * Prepare and submit for review accurate source documents related to all research procedures. * Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). * Develop and maintain research protocol documentation and operations. * Assist researchers with study testing, observations data entry and other duties associated with study sessions. * Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations. * Organize, prepare and distribute informational materials and provide support to the educational mission of the study. * Researches changes and updates to Good Clinical Practices (GCP) and prepares summaries, job aids and training materials for research staff and new clinical research coordinators. * Mentor new clinical research coordinators on all aspects of research support. * Protocol Documentation: Work products related to the development and enforcement of study protocols. * Documentation related to IRB compliance, including adverse event reporting and consent document updates. * Manual: A complete and up-to-date operations manual, along with records of updates and revisions. * Collaborator Engagement: Organize and develop partnerships with stakeholders across various sectors and different members of the community, including participants. (Weekly). Basic Qualifications: * Masters Degree in Public Health, Epidemiology, Clinical Research, Neuroscience, Community and Public Health, Cognitive Science and Biopsychology, or a related field. * Clinical Research Coordinator Certification (CCRC) or an equivalent qualification. * Basic Life Support Certification. * Skilled in RedCap. * Extensive experience managing community-based epidemiological studies, particularly within historically marginalized communities. * In depth knowledge of Institutional Review Board (IRB) regulations and Good Clinical Practice (GCP) guidelines - Expertise in designing, implementing, and conducting community-based longitudinal epidemiologic studies, demonstrated by CCRC certification or equivalent training. * The ability to work independently, make informed decisions, and manage complex research operations. * Strong communication, project management, and leadership skills - Mastery of the theory and methods involved in planning, designing, implementing, operating, analyzing, and assessing cross-sectional, longitudinal, and epidemiological studies, particularly in biomedical and behavioral research. * Proficiency in writing study protocols and research-related documents, with expert knowledge of clinical trial practices and regulations. * Ability to summarize and present scientific research, including statistical analyses, both verbally and in writing. * Expertise in selecting and applying techniques for recruiting and retaining difficult-to-sample and vulnerable populations. * A valid Maryland driver's license with a good driving record. * Ability to lift and carry up to 30 pounds. Minimum Qualifications: * Ability to multi-task and pay close attention to detail. * Excellent analytical, organizational and time management skills. * Strong communication skills, both oral and written. * This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above 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. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at ********************. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics. This position is contingent upon contract award.

Overview Join the HJF Team! HJF is seeking a Clinical Research Coordinator II to adhere to legal, professional, and ethical codes regarding confidentiality and privacy, and to help ensure that protocol requirements are achieved within Good Clinical Practices. This position directly supports the Department of Pediatrics and collaborates closely with the Department of Medicine, both located at the Uniformed Services University (USU) in Bethesda, MD. The Clinical Research Coordinator II supports studies sponsored by the Department of Pediatrics at the Uniformed Services University of the Health Sciences (USU) and led by USU researchers. The current pediatric research effort centers on a project aimed at examining how the pediatric immune system reacts to SARS-CoV-2, influenza, or RSV. HJF provides scientific, technical, and programmatic support services to the Pediatric Department to conduct this research. This position will also provide coordinated support to the Translational Medicine Unit (TMU) within the Department of Medicine at the Uniformed Services University (USU). The TMU is an outpatient clinical research center at USU on the campus of the Walter Reed National Military Medical Center (WRNMMC). The TMU conducts sponsored research in partnership with numerous stakeholders within USU and external industry partners. The TMU supports the clinical stage development of medical products by advancing scientific knowledge regarding clinical outcomes, with a particular focus on product safety. This position requires the incumbent to work closely alongside Principal Investigators and senior research leaders to assist in performing clinical research in support of various clinical research protocols. The incumbent will adhere to legal, professional, and ethical codes concerning confidentiality and privacy. The incumbent will help ensure protocol requirements are achieved within Good Clinical Practices. The desired candidate will also have laboratory processing knowledge or the ability to learn how to support the research team in sample collections and preparations. The incumbent will perform work in compliance with and according to established guidelines and quality control standards. The incumbent will work closely with the Principal Investigator (PI) to organize the research team, ensure team trainings are completed, and maintain exceptional study related records. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals. Note: This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years. Responsibilities Coordinate protocol applications and consent forms for Institutional Review Boards. Prepare and submit required institutional and federal documentation for the conduct of the trial. Manage regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, and updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintain accurate, regulatory-compliant program/study binders. Coordinate efforts among all agencies involved in the protocol approval process. Review new participant records and screen participants for eligibility in research protocols. Interview participants for protocols and collect and analyze appropriate data for recruitment purposes, determine participant commitment, and obtain informed consent. Educate participants about the research protocol, their roles in the protocols, and any other vital information. Collect, organize, catalog, disseminate, and maintain appropriate files of current data. Maintain weekly/monthly status reports on all participants. Educate participants about the clinical trial, their roles in the protocols, and any other vital information. Serve as a resource for participants and act as a liaison between participants and physicians. Ensure all human research protection (HRP) education is current, per study/project needs. Assist and lead in drafting standard operating procedures (SOPs), coordinating in-services with clinical and research staff, and maintaining training logs within the scope of the research projects. Collaborate with the Program Director and Managers to assess, evaluate, and maintain training standards and address the educational needs of the staff. Provide regulatory guidance and training to employees as needed. Transcribe and resolve queries of data in case report forms (hardcopy or electronic) and prepare documents under the direction of project heads. Schedule participants for appointments and visits. Assist with monitoring audits/visits for protocols. Create and maintain accurate documents and records in multiple databases/software programs. Coordinate and assist program management and investigators on the regulatory and clinical inputs on contracts and develop cost-per-participant study budgets. Adhere to legal, professional, and ethical codes with respect to confidentiality and privacy. Ensure protocol requirements are achieved within Good Clinical Practices. May perform laboratory procedures to assist supervisors with various tests, assays, and experiments. May be trained to perform clinical procedures to including vital signs, phlebotomy, and nasopharyngeal sample collection. Maintain laboratory equipment and perform general procedures such as monitoring, calibration, and preventative maintenance. Compile, coordinate, and assist in the collection, processing, and submission of data in a timely and organized manner. May provide direction, feedback, and evaluation of research support personnel, including junior research coordinators and/or assistants. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance at and participation in required training for the role. Qualifications Education and Experience Bachelor's Degree Minimum of 3-5 years experience required Required Knowledge, Skills and Abilities Working knowledge of a broad range of medical specialties; working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e. g. , 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314, 45 CFR 46, FDA Form 1571, and FDA Form 1572). Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions. Must be familiar with phlebotomy, preferably pediatric. Must possess excellent interpersonal and collaborative skills. Flexibility and self-direction in a dynamic research environment. Mastery of basic functions in Word, PowerPoint, Google Drive, Google Meet, Excel. Capacity to learn advanced functions in Word, PowerPoint, Google Drive, Google Meet, and Excel to support research efficiency. Ability to communicate effectively and work with individuals at all levels. Regulatory and research experience with infectious diseases is preferred. Clinical skills experience with vital sign measurement, and nasal specimen collection is preferred. Comfort with engagement with pediatric participants is preferred. Physical Capabilities Lifting: Requires lifting materials up to 10 lbs. Work Environment This position will take place primarily in a Clinic setting. Compensation The annual salary range for this position is $57,650-$80,000. Actual salary will be determined based on experience, education, etc. Benefits HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more. Security Requirements: Ability to obtain and maintain a T1 Public Trust Investigation. Some HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required. Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1. 35(c) Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Department: College of Public Health Classification: Research Staff 12-month Job Category: Research Staff Job Type: Full-Time Work Schedule: Full-time (1.0 FTE, 40 hrs/wk) Workplace Type: Hybrid Eligible Salary: Salary commensurate with education and experience Restricted: Yes Criminal Background Check: Yes About the Department: Founded in 2006, the Department of Global and Community Health offers a BS in Community Health; a MS in Global Health; a MPH with concentrations in Community Health Promotion, Epidemiology, Food Security and Nutrition, Global Health, Health Equity and Social Justice, Health Policy, and Public Health Practice (online); and a PhD in Public Health with concentrations in Epidemiology and Social and Behavioral Sciences, enrolling over 600 students. All degree programs are accredited by the Council on Education for Public Health. The department includes 26 full-time faculty members with backgrounds in biostatistics, environmental health, epidemiology, global health, and social and behavioral sciences, who are committed to the ideals of health equity and social justice among underserved domestic and global populations. About the Position: The Department of Global and Community Health at George Mason University has a position for a Research Coordinator for the project "Engaging Virginia Youth and Community in Designing LGBTQ+ Inclusive Vaping Prevention Interventions" under the direction of Dr. Rima Nakkash and Dr. Ken Griffin. The Research Coordinator manages project coordination, team communication, study execution, grant proposals, and research dissemination. Collaboration with research partners, LGBTQ+ organizations, and stakeholders is essential. Opportunities exist for professional growth and skill development. Responsibilities: Project Management * Coordinates research activities, manages the research team, and ensures that all project milestones are achieved on time. Team Leadership * Leads and manages research team meetings, fosters collaboration, and ensures all team members are aligned with project goals. IRB Protocols * Develops and monitors Institutional Review Board (IRB) protocols to ensure compliance with ethical standards. Stakeholder Engagement * Collaborates with LGBTQ+ organizations and other stakeholders to recruit advisory committee members, ensuring that the intervention is inclusive and community-driven. Data Collection and Analysis * Participates in data collection through recruitment and interviews of community experts and supports the analysis and ensures the integrity of the research findings. Dissemination * Supports in development of manuscripts for publication. Required Qualifications: * Bachelor's degree in related field, or equivalent combination of education and experience; * Some experience in conducting health services, public health, or other health-related research; * Working knowledge of the LGBTQ+ community and associated disparities; * Exceptional attention to detail in interpreting and implementing protocols and ensuring accurate and reliable data collection; * Excellent written and verbal communication skills in English; * Demonstrated proficiency in Excel, Word, PowerPoint, Adobe, and project management software; * Ability to work independently and collaborate effectively with faculty, staff, and healthcare professionals across various levels; * Ability to handle protected health information and human subject-related matters; * Capacity to interpret basic statistical results; and * Ability to collaborate with investigators in drafting project proposals, plans, manuscripts for peer-reviewed publications, and project reports. Preferred Qualifications: * Master's degree in related field, or equivalent combination of education and experience. Instructions to Applicants: For full consideration, please apply for the Research Coordinator position (Requisition #10001881) at ********************** Complete and submit the online application that includes (1) Cover letter, (2) resume, and (3) contact information for three professional references (one being your most recent supervisor). Posting Open Date: October 29, 2024 For Full Consideration, Apply by: November 12, 2024 Open Until Filled: Yes

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world. Requirements Georgetown University's Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center (**************************** , seeks to prevent, treat, and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community - guided by the principle of cura personalis, "care for the whole person." Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the D.C. Metro area and Hackensack Meridian Health in northern New Jersey. The Clinical Research Coordinator I serves as clinical research coordinator for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center. S/he documents and collects data to support protocol screening and determine compliance with eligibility requirements. Additional duties include, but are not limited to: + Oversee the overall coordination of assigned clinical trials throughout the trial lifecycle. + Collaborate with investigators and more senior study team members by participating in recruitment and selection of study participants. + Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines. + Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines. + Assist in the assessment, management, and coordination across the continuum of care (outpatient, inpatient, and home) including triage of phone calls, symptom management, and proactive patient communication. + Coordinate collection of research specimens per protocol requirements, providing patient education about clinical trial participation, treatment, potential side effects, and required testing. + Schedule/conduct in-service training for appropriate staff on assigned clinical trials. + Regularly update the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials. + Collaborate with Data Manager(s) to assure documentation for the clinical trial is complete and accurate, assisting with query resolution in a timely manner. + Document and report serious adverse events per protocol and institutional policy. + Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors. Work Interactions The Clinical Research Coordinator I reports directly to the Clinical Research Manager and works closely with Disease group members (Principal Investigators, Physicians, Clinicians). This position collaborates with the Clinical Research Management Office (CRMO) members (Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians). They also work with external department clinicians and staff (Infusion Nurses, Oncology Pharmacists, hospital staff) along with clinical trial sponsors, auditors, and study monitors. S/he performs all duties in accordance with applicable laws and regulations and adheres to Georgetown University Medical Center's philosophies, policies, and SOPs. The incumbent works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice. Requirements and Qualifications + Bachelor's Degree in a scientific or health related field + Two (2) years of related experience in clinical research preferred + Strong candidates exhibit the ability to work independently and function within a team, strong attention to detail, and is reliable and able to prioritize competing responsibilities Work Mode Designation This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website: *************************************************** 44,022.00 - 83,642.00 USD Annual Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $44,022.00 - $73,406.80 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors. Current Georgetown Employees: If you currently work at Georgetown University, please exit this website and login to GMS ( gms.georgetown.edu ) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown. Submission Guidelines: Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions. Need Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here (******************************** for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at ************ or ********************. Need some assistance with the application process? Please call ************. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website (**************************************** . EEO Statement: Georgetown University is an Equal Opportunity/Affirmative Action Employer (****************************************************************************************************************************************** fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation) , disability status, protected veteran status, or any other characteristic protected by law (***************************************************************** . Benefits: Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website (************************************************* .

Job Details Experienced Rockville MD - Rockville, MD Full Time Bachelors Degree $50,000.00 - $60,000.00 Salary/year None Day BiotechClinical Study Coordinator TITLE AND CLASSIFICATION: Clinical Study Coordinator REPORTING LOCATION: Rockville, MD REPORTS TO: Head of Clinical Operations SCHEDULE: 7:00 AM - 3:30 PM/Weekend on call work may be necessary PRIMARY OBJECTIVES The Clinical Study Coordinator (CSC) serves as the primary supporting role for the Clinical Operations team who manage Champions Clinical Trial Services. The CSC will work closely with the Project Leaders/Study Directors and requires strong communication skills, attention to detail and the need to be highly organized. The CSC manages time-sensitive clinical sample processing, tracking, and documentation within strict timeframes. This role serves as the primary coordinator for sample management, kit logistics, and data entry, requiring exceptional attention to detail, strong time management, and the ability to handle multiple concurrent priorities. The CSC will also interact and liaise with various internal operations groups at Champions to coordinate the scheduling/planning and execution of studies as well as external sites and CRO's regarding clinical sample shipment notifications, scheduling, or kit orders. DUTIES AND RESPONSIBILITIES. To support the Clinical Operations team, duties and responsibilities will include: Enters all samples for clinical trials into the LIMS. Verify and reconcile sample documentation against physical samples as needed Manage urgent sample discrepancy resolution and follow-up Handle customs documentation and courier coordination Schedules clinical samples shipments from sites to Champions and monitors tracking/scheduling. Assists with entry of study information into database(s) for project management purposes. Assists in generating initial study timelines and project kick off documentation. Creates Clinical Sample protocol drafts and data transfer agreements forms. Works with logistics to receive clinical samples and organizes shipment of samples to the client or vendors as needed. Clinical sample kit management: assisting in kit setup for trials, scheduling kit shipments, and inventory management. Assists with other functions such as revenue recognition, project management, sample inventory, samples discrepancies, and data reconciliation as needed. Assists with secure data delivery study data at regular intervals and at completion of client studies. Writes, revises, and reviews SOPs as needed. Identifies and provides resolution to problems involving ongoing studies, as appropriate. Participates and provides feedback in team meetings. Works independently and performs other related duties as assigned. Qualifications KNOWLEDGE, SKILLS AND ABILITIES Knowledge of project management and oncology research. Knowledge in clinical trials preferred. Ability to work in multiple databases to assist in project management. Demonstrated ability to manage time-sensitive tasks within strict deadlines Ability to work in a fast-paced environment with good time management skills. Collaborative, can-do attitude. Timely decision making, good interpersonal skills and an ability to be persistent while maintaining tact. Must have the ability to balance several priorities simultaneously with high attention to detail. Ability for frequent adaptation, self-organization, accountability. Effective oral and written communication skills are required. Proficiency in using Microsoft Word and Excel. EDUCATION AND EXPERIENCE Associate's degree with appropriate experience with a focus on a biology or chemistry related field, oncology a plus. B.S. degree with appropriate experience or M.S. degree is preferred. 1 to 3 years of experience in the field of contract research, clinical research or a similar position is preferred but not required. Experience with clinical sample management and tracking systems preferred Knowledge of GCP/ICH guidelines and clinical trial processes Experience with customs documentation and international shipping protocols preferred This description reflects management's assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The Pulmonary Hypertension research specialist is a key member of the Cardiac Pulmonary Hypertension (PH) Service line. This position will have primary responsibility for coordination of clinical trials. The position will support and act as a resource to the Pulmonary Hypertension health care team. The research specialist will perform clinical and administrative procedures including data collection and tracking, billing. Specifically, they will need to build and manage all ONCORE related procedures. The position will ensure that GWMFA research projects adhere to regulatory and clinical research guidelines. The candidate will be responsible for all IRB activities involving PH research projects, including initial approvals, amendments, reportable events, and closures as appropriate. The specialist will need to manage the practice registry, the pulmonary hypertension association registry, and our biorepository. This individual strives to achieve positive patient care outcomes throughout the disease process by practicing according to the standards of care and procedures and policies provided by GW Medical Faculty Associates. * This position is contingent on grant funding. The grant is slated to end 04/2030 Essential Duties and Responsibilities to perform this job successfully, and individual must be able to perform each essential duty satisfactorily. Other duties may be assigned. The Research Coordinator performs the following duties/responsibilities for the assigned Practice Area: * Maintain updated files on all on-going IRB studies and protocols including the correspondence of informed consent forms, marketing materials, and data collection forms. * Maintain secure files on all protected study related data. * Maintain updated information on study progress and participate in recruitment, consent, follow-up and other study procedures. * Maintain a schedule of IRB related deadlines for annual study renewal and closure. * Help with study related follow-up calls when appropriate. * Work with investigators on submitting study results at investigational meetings for publication. * Maintain files on all presented and published study results. * Maintain updated documentation of all IRB required CITI training. * Facilitate additional research items including but not limited to study registration on clinicaltrials.gov and assistance with Investigational New Drug (IND) items. * Facilitate grant submissions and requests for funding. * Ensure compliance with research protocols and federal regulations. * Maintain Manual of Operations for clinical trials. * Establish Data and Safety Monitoring Boards. * Assist in tracking site enrollment, performance information, and subject study status. Establish methods to track follow and maintain subjects. * Screen and enroll research participants, obtaining informed consent, including a review of medication histories to see if subjects are eligible for enrollment, conduct interviews with subjects, help patients to enter data on research data sheets (also known as eCRFS) and enter in the REDCap database. The research coordinator will schedule/arrange all activities related to research visits and act as a liaison between patients, physicians and staff members. * Additional duties include assisting the PI with day-to-day affairs of the site activities as they relate to the clinical management of the Clinical Trial. Regulatory/Policy * Demonstrates awareness and compliance with GWMFA and GW Hospital policies and procedures. * Complies with standards and regulations of licensure, regulatory and accrediting agencies. * Knowledge or medical research standards, protocols, and regulations applicable to the position/Practice area. * Competes all required regulatory training by ASCR and required for individual trials * Manages IND submission and the regulatory INDs with the PH Director. Other Duties The Research Coordinator may also: * Perform other duties as needed to support the timely completion of research projects that are consistent with established protocols. * Participate in preparation of new research proposals. * Work together with others in the study protocols, such as research coordinators, physicians and technicians. * Serves on appropriate MFA and Hospital committees, providing leadership about pulmonary hypertension initiatives * Provides consultation in pulmonary hypertension specialty area to patient care teams and multidisciplinary team members, coordinating pulmonary hypertension research care between inpatient and outpatient settings (including GWUH) * Prepares for PH Association accreditation procedures as it applies to research with the Director of the PH Program Professional Development: * Determines own professional needs through on-going self-assessment and evaluation of role performance and assumes responsibility for meeting those needs. * Attends relevant workshops, conferences and seminars, locally and nationally. * Belongs to appropriate professional and/or specialty organizations, keeping abreast of current research regarding pulmonary hypertension * Disseminates professional contributions in lectures and seminars. Minimum Qualifications 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 duties. Education A bachelor's degree preferred or equivalent combination of training and experience. ACRP-CCRC Certification preferred. Experience Three + years' experience in clinical research preferred as well as applicants with previous clinical research background. Competencies The requirements listed below are representative of the knowledge, skills, and/or traits required for success in this position. Research Coordinator must demonstrate: * Knowledge and support of GWMFA's vision, mission statement, values, and guiding principles. * Current knowledge of medical research standards, protocols, and regulations applicable to the position/Practice Area. * Excellent interpersonal skills for communicating professionally, cheerfully, and effectively with study participants, families, physicians, and coworkers. * Good written communication skills for the preparation of coherent research summaries. * Proficiency reading documents and following instructions written in English. * The ability to work well with others across differences and resolve conflicts when they occur. * Familiarity with the technology/equipment utilized by the research project. * Compassion, patience, and calm. * Integrity, with appropriate concern for confidentiality. * Flexibility, initiative, and self-direction. * Attention to detail and ability to manage multiple priorities. * Concern for quality and accuracy. Physical Requirements * Sit, stand, bend, reach, and walk for long periods of time in an office setting. * Must be able to occasionally lift, carry, push, or pull over 100 lbs. as part of the role. * Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment. Other Requirements None at this time Supervision Received Department Research Physician Leadership and Senior Director of Clinical Research Operations. Direct collaboration with Physician Fellowship / Research Liaisons Supervision Exercised Supervision over data entry or support staff for research. About GW MFA MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals. The GW MFA's leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.

Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional Accountabilities Responsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional Accountabilities Responsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional Accountabilities Responsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional Accountabilities Responsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance