Clinical Research Coordinator Jobs in Mitchellville, MD

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.

Job Summary/Company: Sparks Group is partnered with a leading healthcare research institute to hire Manager, Clinical Trials Office (Finance). As the Manager, you will be responsible for the leadership and operations of clinical trials and clinical research financial administration, both pre and post award, and processes that support Medicare Coverage Analysis (MCA), revenue cycle integrity and accurate clinical research billing. If you're looking for an exciting next step in your career with a nationally recognized healthcare research organization, apply now! Responsibilities: Provides direct oversight of the Clinical Trials Office including Medicare Coverage Analysis (MCA) and clinical research revenue cycle Development of short and long terms goals and objects for the team that align with Grants and Contracts Finance and institutional goals and regulatory requirements for research. Defines qualifications and performance expectations for staff positions based upon departmental goals and team goals. Conducts performance conversations with direct reports to discuss progress towards goals, performance of responsibilities, provides coaching, mentoring, and counseling. Applies problem solving, team building, and decision-making methods in daily operations Qualifications/Background Profile: Bachelors degree healthcare, scientific, business administration, finance or related Field 7 years' experience in research administration, health related field, accounting or business which includes clinical research experience Expertise in Medicare Coverage Analysis (MCA), revenue cycle integrity and accurate clinical research billing. Acquire Certified in Research Administration (CRA) or Healthcare Research Compliance (CHRC) within 5 years Strong project management, facilitative leadership, detail orientation, organizational, customer service, and oral written communication skills required Supervisory experience is required ----------------------------------------------------------------- This job is Hybrid Remote. Pay Range: Salary $115,000.00 to $125,000.00 We offer several comprehensive benefits package including health and life insurance, paid and unpaid time off, and retirement and savings plans to qualifying employees.

The Clinical Research Coordinator II (CRC II) will support our Client's Research Institute in their Women's & Infant's Services research group to play a pivotal role in coordinating and managing clinical research studies. This position involves ensuring compliance with protocols, regulatory requirements, and organizational policies while supporting investigators and research teams to achieve study objectives. Responsibilities -Oversee clinical research projects, including study startup, implementation, monitoring, and closeout -Coordinate study activities with principal investigators, research teams, and external sponsors -Prepare and submit IRB applications, amendments, and continuing reviews -Ensure adherence to federal, state, and institutional regulations -Identify, screen, and recruit eligible participants for clinical trials -Obtain informed consent and ensure participant understanding of study procedures -Collect, document, and manage study data in compliance with protocol requirements -Utilize electronic data capture systems and resolve data queries in a timely manner -Assist in internal and external study monitoring and audits -Prepare and present progress reports, adverse event reports, and study updates -Serve as the primary point of contact for study sponsors, regulatory agencies, and research team members -Participate in team meetings, trainings, and quality improvement initiatives Required Qualifications: -Education: HS Degree minimum -3+ years of experience in clinical research within a healthcare setting -Strong patient engagement experience -Experience with in-person study recruitment -Experience with administrative responsibilities associated with clinical research studies -Regulatory/compliance management, documentation, etc. Preferred Qualifications: -Women's Health research experience -Certifications/licensure such as CCRC, CCRP, etc. are a plus

CVS Health Location: Annapolis, Maryland Type: Non-Remote Posted on: December 5, 2024 Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand - with heart at its center - our purpose sends a personal message that how we deliver our services is just as important as what we deliver. Our Heart At Work Behaviors™ support this purpose. We want everyone who works at CVS Health to feel empowered by the role they play in transforming our culture and accelerating our ability to innovate and deliver solutions to make health care more personal, convenient and affordable. Position Summary CVS Real World Evidence partners with leading global biopharma and research clients to design studies and deliver qualified patients into ongoing Real World Evidence studies. The Clinical Study Senior Manager will report to the Director, RWE Study Management and lead the delivery of RWE research studies What you'll do: • Post-sale, you will lead all elements of planning and execution of complex RWE studies including managing all deliverables for a study; including management of efforts across multiple internal teams; engaging various levels of management (ex: Legal, Privacy, Compliance, Digital) and external stakeholders including vendors (ex: eConsent vendors, data vendors, etc.) to ensure the success of the study • Take accountability for the financial performance of the study including managing the revenue, costs, and financial forecasting of associated study milestones • Serve in a Sponsor-facing role and is expected to actively manage the relationship with the study sponsor, principal investigator, and other key stakeholders • Serves a key role in problem solving and escalation of study issues • Provide direction to and mentor Clinical Project Mangers Required Qualifications • 7+ years of Project Management to include previous health care or clinical trial project leadership experience Preferred Qualifications • Demonstrated subject matter expertise in the design and conduct of real-world evidence studies • Strong understanding of clinical research principles and process • Ability to negotiate and influence with diplomacy to achieve results • Degree in Life Sciences or related discipline or significant experience in clinical trials • PMP Certification Education • Bachelor's Degree • Equivalent experience may be considered Pay Range The typical pay range for this role is:$67,900.00 - $199,144.80 This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above. This position also includes an award target in the company's equity award program. In addition to your compensation, enjoy the rewards of an organization that puts our heart into caring for our colleagues and our communities. The Company offers a full range of medical, dental, and vision benefits. Eligible employees may enroll in the Company's 401(k) retirement savings plan, and an Employee Stock Purchase Plan is also available for eligible employees. The Company provides a fully-paid term life insurance plan to eligible employees, and short-term and long term disability benefits. CVS Health also offers numerous well-being programs, education assistance, free development courses, a CVS store discount, and discount programs with participating partners. As for time off, Company employees enjoy Paid Time Off ("PTO") or vacation pay, as well as paid holidays throughout the calendar year. Number of paid holidays, sick time and other time off are provided consistent with relevant state law and Company policies. For more detailed information on available benefits, please visit Benefits | CVS HealthWe anticipate the application window for this opening will close on: 05/31/2025Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws. no requirements Employment Type: OTHER

JOB\_DESCRIPTION.SHARE.HTML CAROUSEL\_PARAGRAPH JOB\_DESCRIPTION.SHARE.HTML * Fort Belvoir, Virginia * Clinical Research * 5130 ** Job Description** **Join the HJF Team!** HJF is seeking a **Clinical Research Associate II** who monitors the execution of clinical trials associated with specific projects. Ensures that all necessary steps are taken towards safety provisions and all regulations are adhered. This position is a part-time role up to 10 hours per week. This position will be in support of the Warfighter Refractive Eye Surgery Program and Research Center (WRESP-RC). The primary mission of the WRESP-RC is to provide refractive surgery to our nation's warfighters so that they might perform their duties on the battlefield without the need for spectacle correction. One of the unique features of the WRESP is that it is not necessarily a "medical “program but a "medical readiness" program. The secondary mission is to critically investigate military aspects of refractive surgery to improve the visual function of America's warfighters on the modern battlefield. 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 * Assists in the submission of protocol application and consent forms to the local Institutional Review Board (IRB). Ensures that all amendments, continuing reviews and adverse events have been submitted to the IRB. * Facilitates initiation, monitoring, and closeout of study. Assist in completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and suggest actions to obtain compliance. * Performs data collection, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring GCP are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements. * Prepares scientific and technical reports, presentations and publications in collaboration with other study team members. * May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for the role; assist in study recruitment, consent process and perform study-related testing on-site, as needed. Qualifications **Education and Experience** * Master's Degree in a related scientific discipline required. * Minimum of 3 to 5 years experience required. **Required Knowledge, Skills and Abilities** * Working knowledge of medical specialties including Ophthalmology. * Working knowledge of all applicable federal and military regulations regarding the use of human subjects in research. * Must be familiar with Institutional Review Board activities and actions. * Must be able to set and meet deadlines. * US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. **Physical Capabilities** * Lifting: Requires lifting materials up to 10 lbs. **Work Environment** * This position will take place primarily in an office setting. **Compensation** * The hourly pay range for this position is $27.72-$40.49. Actual hourly pay 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. 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.*

Zachary Piper Solutions is seeking a Clinical Research Associate to join a large CRO located in Washington to travel regionally for site support and monitoring. The Clinical Research Associate will conduct On-Site monitoring for multiple research locations supporting Oncology trials. This job opens for applications on 01/07/2025. Applications for this job will be accepted for at least 30 days from the posting date. Responsibilities of the Clinical Research Associate include: * Travel to multiple sites within the California and Washington Market. * Collaborate with sites to develop and track recruitment plans ensuring project needs are met. * Provide protocol and study training to sites. * Oversee regulatory submissions, enrollment, CRF completion and data query resolution. * Ensure all site documents are filed in the TMF and ISF per GCP/ICH guidelines. * Mentor clinical staff through co-monitoring and training visits. Qualifications for the Clinical Research Associate include: * 1-3+ years of experience in on-site monitoring for oncology clinical trials. * 1.5 years of Phase 1 oncology. * Proficient in GCP and ICH guidelines * Excellent computer skills including Microsoft Office Suite. * Effective communication, organizational, and problem-solving skills * Experience working within a large CRO preferred over Academia experience. Compensation for the Clinical Research Associate: * Salary Range $100,000 - 120,000 Depending on experience * Full Comprehensive Benefits, Medical, Dental and Vision coverage * Parental Leave KEYWORDS Clinical Research Associate, Site Monitor, Clinical, Clinical Research, Oncology, Clinical Trial Associate, CRO, Industry, Patient Recruitment, Site Support, TMF, Trial Master File ETMF, GCP, FDA,CRA, Clinical Research Training, Informed Consent, Healthcare, Health and Medical, Life Science, Cancer Research, Oncology Research, L-TH1, L-DNP, #Pando, Travel

We are actively recruiting for an experienced Clinical Research Coordinator III to join our cardiology research team with MedStar Health Research Institute onsite at MedStar Washington Hospital Center in Washington, DC. Under the guidance of the Clinical Trial Manager, the Clinical Research Coordinator (CRC) 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

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

Overview Join the HJF Team! HJF is seeking a Clinical Research Associate II who monitors the execution of clinical research studies as well as performs data collection for multiple research projects related to creative arts therapies. The Clinical Research Associate will provide regulatory support for associated clinical research projects and will assist in recruitment and data collection efforts. Ensures that all necessary steps are taken towards safety provisions and all regulations are adhered. This position will be in support of National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center (WRNMMC). NICoE is a DoD institute dedicated to providing cutting-edge evaluation, treatment, and research for service members dealing with complex interactions of mild traumatic brain injury (mTBI) and psychological health (PH) conditions. The position will provide support for a portfolio of creative arts therapies research projects including two main projects. The first project evaluates the impact of art therapy on posttraumatic stress symptoms and the second projects assesses the ability of wearable sensors to quantify movement during dance movement therapy. 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 Submits protocol application and consent forms on behalf of PI to local Institutional Review Board (IRB). Ensures that all amendments, continuing reviews and adverse events have been submitted to the IRB. Assists with study recruitment and data collection efforts. Ensures that regulatory documents are maintained and are up to date. Maintains accurate regulatory compliant program/study binders for each study. Assures sufficient investigator qualifications, training, facility resources, laboratories, equipment, and staff to properly support studies. Monitors and assesses the clinical research site's patient recruitment and retention success. Assists with the preparation of project-related deliverables and broader dissemination efforts (e. g. , written manuscripts for submission to scientific journals and annual reports to study sponsor). May train other Clinical Research Associates or Assistants. 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 Master's Degree required Minimum of 3 to 5 years experience required Required Knowledge, Skills and Abilities Knowledge of federal and local regulations and policies pertinent to research involving human subjects. Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions. Familiarity with clinical research methods. Excellent communication and demonstrated interpersonal skills required to work successfully and professionally within multi-disciplinary teams and with participants. Skill in using computers and relevant software, including electronic clinical data capture system, SPSS, Excel, Endnote, Adobe, and PowerPoint. Background in neuroscience or creative arts therapies research is strongly preferred. The ability to obtain and/or maintain a T1 Public Trust with CAC. Physical Capabilities Lifting: Requires lifting materials up to 10 lbs. Ability to stand or sit at a computer for prolonged periods Work Environment This position will take place primarily in a office or clinic setting. Compensation The annual salary range for this position is $57,650-$75,000. 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. 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.

Sr. Clinical Research Program Coordinator We are seeking a Sr. Clinical Research Program Coordinator who will be responsible for implementing and completing Cardiology/Electrophysiology clinical trials with a high degree of independence in performance of functions. The Sr. Clinical Research Program Coordinator will maintain knowledge of study protocols and assist in the daily operations of the recruitment under the direction of the Principal Investigator and Co-Investigators and will manage and coordinate patient related tasks of Cardiology/Electrophysiology patients participating in clinical trials. Will work on clinical studies which require a high level of understanding. Must be able to multi-task an 50% of the Coordinator's time will be devoted to Patient Centered mobile Health TECHnology Enabled Atrial Fibrillation Management (mTECH Afib), pilot randomized clinical trial which evaluates feasibility and preliminary efficacy of the health equity centered virtual atrial fibrillation management program. Recruiting patients, onboarding them with digital health tools (Mobile App, wearable devices, etc..), and data management are among the primary responsibilities for this trial. The other 50% will be devoted to study activities for other clinical trials in the Electrophysiology department. Specific Duties & Responsibilities * Recruits, instructs, and coordinates research subjects to specific study objectives and work scope. * Schedules study follow-up visits and research related tests to ensure that subjects are seen in the study window timeframe to minimize protocol deviations. * Implements and maintains data collection and analysis systems in support of research protocol, including management of data, paper files, subject binders and electronic databases. * Ensures the smooth and efficient day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes. * Acts as the primary administrative point of contact for internal research staff. * Process all sponsor requests for study revisions and required reporting. * Coordinates the day-to-day activities in the carrying out of research protocol, may perform aspects of research protocol in accordance with specified program objectives. * Develops and maintains records of research activities and prepares periodic and ad hoc reports as required by investigators and/or regulatory bodies. * Assists with reporting protocol deviations and adverse events in a timely manner. * Assists with maintaining study inventory according to regulatory standards. * Works with Compliance Committees and Institutional Review Boards. * Assists with IRB submissions/applications. Prepares and maintains IRB and other regulatory documentation for multiple projects. * Maintains compliance with Good Clinical Practice Guidelines, ICH Guidelines, IRB requirements and Federal Regulations pertaining to research. * Performs miscellaneous job-related duties as assigned. Special Knowledge, Skills, & Abilities * Ability to prioritize and coordinate multiple tasks. * Ability to work well and communicate effectively with others. * Strong organizational skills, attention to detail, able to work independently and as part of a team, initiative, strong leadership skills * Ability to work with a team of researchers and with diverse subject populations. * Excellent oral and written communication skills. * Ability to learn new database and software applications * Ability to follow multiple, detailed directions of various protocols. * Excellent time management skills. Minimum Qualifications * Bachelor's Degree in related discipline. * Three years related experience. * Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula. Preferred Qualifications * Knowledge of medical terminology highly desired. Classified Title: Sr. Research Program Coordinator Job Posting Title (Working Title): Sr. Clinical Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($56,250 targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30-5:00 Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM DOM Cardiology Personnel area: School of Medicine Total Rewards The referenced base salary range represents the low and high end of Johns Hopkins University's salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: ************************************** Education and Experience Equivalency Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job. Applicants Completing Studies Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date. Background Checks The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function. Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion. Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. EEO is the Law ******************************************************************************************** Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at **********************. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit ******************************* Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit ************************************************************* and all other JHU applicants should visit *********************************************************************** The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office. Hybrid: On-site 3-4 days a week

About Us DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools - including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, simulation, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovation to improve the lives of millions. Overview DLH Corp is currently seeking a Clinical Research Associate position in support of an on-site National Institutes of Health, National Institute of Environmental Health Sciences (NIH/NIEHS) client at the NIH Bethesda, MD campus and remote support to our client at the NIH/NIEHS Durham, NC campus. Broadly, as the Clinical Research Associate, this position will support all aspects of the clinical trial process, including patient recruitment, data collection, and study compliance monitoring, and will be responsible for ensuring the safety and integrity of research participants, serving as the primary on-site contact for the study, and ensuring the trial adheres to regulatory guidelines and ethical standards. General Responsibilities: Implement study activities in compliance with ICH GCP, NIH, and FDA regulations Conduct data entry of protocol study forms Other general data entry Assist the study team in creating, preparing, and reviewing study forms and completing quality control checks in accordance with FDA and NIEHS Environmental Autoimmunity Group (EAG) guidelines Collaborate with study coordinators and other team members to assist with patient enrollment activities including recruitment, screening, scheduling, follow-up, and payment Assist study coordinators with regulatory submissions to the NIH Institutional Review Board (IRB). Request Medical records Collaborate with the study team to maintain the regulatory binder Collaborate with the study team to prepare for monitoring visits Assist the laboratory staff in the assembly of sample mailing kits Maintain iPads used for data collection Review completed study forms with patients and provide assistance in form completion and other patient interactions Support the study team in developing and maintaining study manuals and tracking sheets Participate in study meetings and take detailed minute notes Edit study forms to be integrated into REDCap Coordinate and assist with sample delivery and pick-up as needed Serve as the backup for the EAG lab technician tasks as required Assistance with responding to participant inquiries Support with drafting study-related newsletters and/or other participant outreach communications Provide additional support for various study needs as required Hybrid working schedule - 80% onsite in Bethesda, MD, and 20% telework Qualifications Required: Ability to plan, prioritize, and organize workflow and procedures Excellent communication skills and ability to work collaboratively with a team Ability to write clearly and concisely for regulatory reporting and submissions Work independently with minimal supervision Detail-oriented and able to take accurate meeting minutes Flexibility to assist with various study tasks as needed Experience supporting clinical studies and working with human subjects Experience with REDCap data entry Proficiency with MS Word, Outlook, and Excel Experience with working with Personally Identifiable Information (PII) and keeping participant information confidential Desired Skills, Experience, Certifications: Familiarity with ICH GCP, NIH, and/or FDA regulations for conducting human subjects research Experience with patient enrollment and interactions, phone screening, and scheduling Proficiency with REDCap for creating and editing study forms Knowledge of medical terminology Human Subjects Research and Good Clinical Practice Certification Minimum Education/Certifications: Bachelor's degree in public health, clinical research, nursing, epidemiology, or other related field Two (2) or more years supporting clinical trials or clinical research in an applied setting that fosters the development of the skills described above Hybrid working schedule - 80% onsite in Bethesda, MD, and 20% telework Basic Compensation: $55,500 - $66,500 yearly salary The salary offered within this range will be based on the selected candidates' skills, experience, education, market data, and internal parity. DLH may offer other rewards, including performance incentives and program-specific awards. An applicant's salary history will not be used to determine compensation. Benefits DLH Corp offers our employees an excellent benefits package including - Personal Time Off (PTO), medical, dental, vision, supplemental life with AD&D, short and long-term disability, flexible spending accounts, parental leave, legal services, and more. We want our employees to save for their future, therefore we offer a 401(k) Retirement Plan, which includes a matching component. DLH is dedicated to your career development, providing training to help drive success, with access to our best-in-class e-learning suite for formal and informal learning, professional and technical certification preparation, and education assistance at accredited institutions. EEO Women, minorities, individuals with disabilities and Veterans are encouraged to apply. DLH Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. DLH will provide a reasonable accommodation to individuals with disabilities and disabled Veterans who need assistance to apply.

**Job no:** 0063358 **Location:** Parkville **Role type:** Full-time; Fixed-term for 24 months **Faculty:** Medicine, Dentistry and Health Sciences **Department/School:** Department of General Practice and Primary Care **Salary:** UOM 6 - $96,459 - $104,413 p.a. plus 17% super * Support the primary care clinical trial and recruit participants * This role allows you to work with a large variety of stakeholders and gives you the ability to travel across different sites. * Salary packaging, subsidised health and wellbeing services, fitness and cultural clubs, Myki discounts, and a 25% discount on graduate courses to our staff and their immediate families! **About the Role**The Department of General Practice and Primary Care seeks a research trial coordinator in our primary care trial unit, led by Prof Jon Emery. The main aspects of the role will be to perform overall study co-ordination and management of The CASSOWARY Trial team. They will supervise and be involved in participant recruitment, implementing trial interventions, and engaging with general practice staff. The research trial coordinator will work individually and lead a team of research officers and research assistants. A key area of the research program is genomic testing for cancer risk and cancer screening. Comprehensive training in trial recruitment processes will be provided. Your responsibilities will include: * Maintain the governance framework, HREC submissions, amendments and the trial protocol. * Manage the day-to-day operations of the CASSOWARY trial including GP clinic recruitment, participant recruitment, data management, safety monitoring, adhering to Good Clinical Practice, liaising with stakeholders and reporting. * Screen, recruit, consent, interview and randomise participants into the trials, and administer the intervention appropriately and consistently * Work with the trial leads to facilitate the delivery of the trial protocols and processes. * Provide and explain trial specific knowledge to general practitioners and other medical practice staff. **Who We Are Looking For** You will the ability to work autonomously and effectively with diverse stakeholders and as part of a team. They possess highly developed organisational skills, attention to detail, and demonstrated ability to meet deadlines and manage competing demands. You will also have: * A tertiary qualification in medical science, health science, or related discipline, with subsequent relevant experience or an equivalent combination of relevant experience and/or education/training. * Proficiency in accurate recording and analysis of data generated from research undertaken. * Demonstrated high level of computing skills including competency with word processing (Microsoft Suite), spreadsheets, data management systems (REDCap), internet and email. * Considerable relevant knowledge and experience in primary care, genomics, or clinical research including demonstrated knowledge of research trial methodology and Good Clinical Practice. For further information regarding responsibilities and requirements, please refer to the attached PD. *This role requires that the successful candidate must undergo and maintain an up-to-date Working with Children Check. This is essential to guarantee a secure environment for all individuals at the University. In the case the selected candidate doesn't have a valid Working with Children Check, they will be able to apply for the WWCC as part of the initial onboarding procedures.* **Please note: Visa sponsorship is not available for this position**. This role requires current valid work rights for Australia. **Your New Team - Department of General Practice and Primary Care** The Department of General Practice and Primary Care at the University of Melbourne is a leading centre for primary care research, training, and innovation. With a network of over 600 community-based practices, we provide quality medical education, postgraduate training, and collaborate on research. Through initiatives like the Data for Decisions program, we ensure privacy while leveraging electronic medical record data. Our research focuses on biostatistics, implementation science, informatics, and co-design, addressing key healthcare challenges. Join us to shape the future of primary care and make a difference in patient outcomes. **What We Offer You!**In addition, we offer the opportunity to be part of a vibrant community and enjoy a range of benefits, including generous leave provisions, salary packaging, health and well-being services and discounts on graduate courses. For more information, check out page! **About the University of Melbourne** We're tightly connected with the community, both at home and abroad. We take pride in our people, who all contribute to our mission to benefit society through the transformative impact of education and research. Discover more via and stay connected with our stories and people on . **Be Yourself**The University of Melbourne values the unique backgrounds, experiences and contributions that each person brings to our community and welcomes and celebrates diversity. First Nations people, those identifying as LGBTQIA+, parents, carers, people of all ages, abilities and genders, and people of diverse ethnicity, nationality and faith are encouraged to apply. Our aim is to create a workforce that reflects the diversity of the community in which we live. For more information please visit page. We are dedicated to ensuring barrier free and inclusive practices to recruit the most talented candidates. If you require reasonable adjustments, please contact the employee listed on the first page of the Position Description found below, with an email containing your name and contact details for a confidential discussion. Please ensure your email is titled "Reasonable Adjustments Request". **Aboriginal and Torres Strait Islander Applicants**We aspire to be the University of choice for Indigenous Australians, with unprecedented investment to attract, nurture and retain Aboriginal and Torres Strait Islander students and staff. Tangible support through a range of programs and initiatives will ensure that you personally succeed and flourish while at the University of Melbourne. For further information, including our 2023-2027 Indigenous strategy please visit - **Join Us! If you feel this role is right for you, please apply with the following documents:** * **Resume** * **Cover Letter outlining your interest and experience** * **The responses against the Selection Criteria^ (found in the Position Description - These will be asked during your application, there is no need to upload a separate document)** ^For information to help you with compiling short statements to answer the selection criteria and competencies, please go to If you have any questions regarding the recruitment process, please feel free to contact Lachlan Bryce via email at *************************, ensuring that you include the Position Number and the Job Title as the subject. Please do not share your application to this email address. If you have any particular questions regarding the job please follow the details listed on the Position Description. for further information.

Saratoga Medical is hiring a Clinical Research Coordinator in Baltimore, MD. Package includes competitive rate, paid time off and benefit options. Saratoga Medical has an exciting opportunity for a Clinical Research Coordinator at Baltimore, MD. This is a great full-time opportunity, 40 hours work week schedule, Monday to Friday, excluding Federal holidays. Please see qualifications below and submit your resume if you are interested in being considered: Minimum Qualifications: • Extensive experience managing community-based epidemiological studies, particularly within historically marginalized communities • Indepth 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 passion for and commitment to health equity research, demonstrated by previous experience working with underserved populations. • Preference for candidates who have shown a history of longterm engagement (3+ years) in previous roles, particularly in communitybased research settings or relevant transferrable fields. Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.

Conducts such activities as account investigation, follow-up and collections on clinical trial/research accounts. Works closely with Center for Clinical Trials regarding upcoming research studies and closely with physicians and study coordinators for patient visit statuses. Requires independent judgment and decision-making ability. EDUCATION and/or EXPERIENCE High school diploma or general education degree (GED) preferred Three or more years of experience in a medical billing office General understanding and application of basic accounting principles PC proficiency Knowledge of GE/IDX, EPIC or similar computerized billing system Knowledge of payers in specialty Knowledge of ICD-10 and CPT coding Understanding of: FSC's and paycodes used in GE/IDX, EPIC or billing system, contractual requirements for the job; importance of compliance with all government regulations regarding billing

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 As a top academic health and science center in the United States, Georgetown University Medical Center (***************************** seeks to provide, in a synergistic fashion, excellence in education - training physicians, nurses and other health care professionals, as well as biomedical scientists - and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health. Emphasizing service, we are dedicated to the Catholic, Jesuit principle of cura personalis - "care of the whole person." Our partnerships with organizations in the region strengthen our work and expand its reach. The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating the ALL ALS studies, primarily in the disease states of Neuromuscular Disorders (ALS). Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. The CRC2 is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning. Additional responsibilities include, but are not limited to: + Conduct the entire study visit for each patient, ensuring that the protocol is followed, which requires an in-depth understanding of the intricacies of each individual protocol and patient needs. + Maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU), communicating and coordinating with such departments effectively. + Perform his/her job maintaining patient confidentiality at all times, adhering to the university requirements for the conduct of clinical research. + Oversee regulatory maintenance, adherence with ongoing training requirements, accurate reporting of clinical trial visits via the OnCore/CTMS system, accurate and timely data entry, accurate and timely reporting of adverse events, and timely communication with team members/ clinical trial sponsors. + Coordinate the ALL ALS studies, which will be conducted at the Georgetown University Hospital Dept. of Neurology main site and with remote patients. + Spend 5 days per week on site for these trials, which is a new national natural history/biobanking study with 35 sites around the country. + Interact with other coordinators around the country on regular meetings and follow a central IRB protocol for all sites. Work Interactions As an employee of Georgetown University, the CRC2 directly supports the University's mission of cura personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical trial protocol, the CRC2 is required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. The CRC2 is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary. In the overall scheme of the Georgetown University Medical Center, this position indirectly and directly coordinates with multiple divisions/departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), Research Pharmacology, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, Pathology, and Gastroenterology. On a daily basis, the CRC2 will report to one of the following: Study PI, Study NP, and/or Associate Director of Clinical Trials. The CRC2 is part of a robust team comprised of approximately 7 CTM/CRC2s (including the CRC2), the Associate Directors, the Director of Clinical Trials, and up to 4 student hires. The CRC2 is responsible for managing the ALL ALS studies within our specific department. The CRC2 may also be asked to provide project-specific deliverables to other studies in the group, but additional studies will kept to a minimum and not the coordinator's priority. The Study PIs, Associate Directors and the Director of Clinical Trials rely on timely responses from the CTM/CRC2s and Director of Clinical Trials to effectively execute their responsibilities. Requirements and Qualifications + Bachelor's degree; Rare exceptions may be made for a candidate with an Associate's Degree and 5 years minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant + A B.A./B.S. or A.A + 5 year CTC experience, the CRC2 must have at least 3 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience + The ideal candidate's 2 year min. experience will be as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position - However, as this is a niche area of expertise, candidates with at least 2-3 years' work experience in the following areas will be considered: human subjects research (e.g., working in a lab or on studies for PhD candidates at an academic institution), social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that directly support Clinical Trials (e.g., the GUMC Clinical Research Operations Office or Clinical Research Unit) + The ideal candidate for this specific position must have experience working with Neurology patients, specifically in MS and neuromuscular clinics. If applicable, the candidate must be able to demonstrate knowledge of their experience working with such patients and possess an understanding of the unique characteristics of these disease states + The candidate should also have previous experience with regulatory maintenance, preparation, and IRB submission activities + Current CITI Group 1 Biomedical, HIPAA, and IATA Training and previous exposure to/experience handling human biological specimens; + Must be able to operate a centrifuge and be capable of processing and shipping laboratory samples independently with phlebotomy experience + The candidate must have previous experience accessing and reading patient medical records and must have a general working knowledge of medical care/medical operations and regulations. + Highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed to providing exceptional service + Must be able to demonstrate moral and ethical responsibility and maintain professionalism at all times with excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department) Work Mode Designation This position has been designated as Hybrid . 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: *************************************************** Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $21.16 - $35.29 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 (************************************************* .

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.

**Job Details** **Clinical Research Coordinator , - (7420)** Share this job as a link in your status update to LinkedIn. **** Job Title Clinical Research Coordinator , Job Description Concentric Methods is seeking a Clinical Research Coordinator to join our team in Bethesda, MD, in support of the NIH. Responsibilities: * Supports clinical staff develop, implement, and maintain clinical research data files and materials. * Perform data analysis of sensory, autonomic, and neuroimaging data. * Collects research data and prepares information for inputs and analysis. * Verify study participant information and collect data and results of testing. * 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. * Conduct somatosensory and pain-related quantitative sensory testing. * Supports the development of forms and questionnaires. * Assist researchers develop, maintain, and complete study data collection forms and source documents. * Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates. * Review draft protocols, case report forms, and manuals of operations for clarity, and completeness. * Work with staff on the design, development, and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries. * Assist researchers design patient Case Report Forms (CRFs). * Work with investigators from multiple NIH institutes and center to design sensory, autonomic, and imaging testing procedures to best characterize pain conditions associated with individual conditions, treatments, and diseases. * 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. * Conduct pain-related neuroimaging studies of patients and healthy volunteers. * Monitors subject's progress and reports adverse events. * Assist staff writing progress reports and contributions to peer-reviewed scientific manuscripts. * Conduct autonomic testing of patients and healthy volunteers. * Supports assembly, development, and review of new research projects. * Assist researchers develop and maintain current and new research protocols. * Participate in the writing of clinical protocols to study pain mechanisms. * Supports the creation and management of clinical websites and web-based tools. * Participate in the writing of scientific papers. *Cape Fox Corporation, its subsidiaries, and affiliates provide equal employment opportunities to all persons and prohibit employment decisions on the basis of race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation. Cape Fox Corporation, its subsidiaries, and affiliates offer preference to Cape Fox Corporation shareholders, descendants, and other Native Americans pursuant to Public Law 100-241.* Travel Requirements 0 - 10% Salary Grade Job Requirements Bachelor's degree - (Neuroscience, Psychology, Biology) Required experience in analytical and statistical software program(s), e.g., SPSS, R, FSL, SPM, AFNI, MATLAB. Category Healthcare Location NIH - Bethesda, MD - Rockville, MD 20892 US (Primary) Education Bachelor's Degree

The Medical Faculty Associates is looking for a clinical research coordinator to join the Division of Infectious Diseases (ID) with responsibilities in clinical research operations. The Division of Infectious Diseases oversees research activities focusing on improving the lives of patients living with HIV, prevention of HIV, latent tuberculosis, and vaccine studies for prevention of HIV, COVID-19, shingles, Lassa fever and Ebola. Research responsibilities would include working as part of the ID clinical research team to screen, consent, enroll and follow patients on multiple studies. **This position is contingent upon grant funding and is slated to end 12/31/2030** Essential Duties and Responsibilities • Serve as the primary contact for research participants, study sponsors and regulatory agencies • Coordinate study activities from start-up through close-out • Perform phlebotomy when needed • Follow clinical and administrative procedures as outlined in study protocols • Interact with research participants in a friendly, prompt, and caring manner, maintaining confidentiality and respect at all times • Be cognizant and respectful of cultural difference in communication approach • Provide daily support for all assigned research projects and related activities including IRB submissions • Willingness to work as a part of a research team in data collection and quality control activities Minimum Qualifications Ideal candidate should have the following qualifications; Education • Bachelor's degree or higher, or an equivalent combination of training and experience Experience • Experience in clinical research related to the field of infectious diseases Physical Requirements Walk, bend, twist, and reach above the shoulder frequently in a clinical setting. Must be able to occasionally lift or carry and frequently push or pull up to 20 lbs. as part of the role Regularly exposed to healthcare settings that may require personal protective equipment Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment. 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. Equal Opportunity Employer The GW Medical Faculty Associates is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.

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