clinical research assistant

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clinical coordination assistant Jobs in Washington

clinical coordination assistant

clinical research coordinator 1

Georgetown University

<div>Georgetown University comprises two unique campuses in the nation&rsquo;s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.
Requirements
Job Overview
This position serves as Clinical Research Coordinator 1 in the Clinical Trials Office for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center. Lombardi CTO Clinical Research Coordinators perform all duties in accordance with applicable laws and regulations. Adheres to Georgetown University Medical Center&rsquo;s philosophies, policies, and SOPs. Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.
Additional duties include, but are not limited to:<ul><li>
Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle</li><li>
Collaborate with investigators and more senior study team members by participating in recruitment and selection of study participants; document and collect data to support protocol screening and determine compliance with eligibility requirements</li><li>
Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines</li><li>
Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines</li><li>
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</li><li>
Coordinate collection of research specimens per protocol requirements</li><li>
Provide patient education about clinical trial participation, treatment, potential side effects, and required testing</li><li>
Schedule/conduct in-service training for appropriate staff on assigned clinical trials</li><li>
Regularly update the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials</li><li>
Collaborate with Data Coordinator(s) to assure documentation for the clinical trial is complete and accurate; assist with query resolution in a timely manner</li><li>
Document and report serious adverse events per protocol and institutional policy</li><li>
Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors</li><li>
Other duties as assigned</li></ul>
Work Interactions<ul><li>
Clinical Operations Team Manager</li><li>
Disease Group members: Principal Investigators, Physicians, Clinicians</li><li>
Lombardi CTO Team Members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians</li><li>
External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff</li><li>
Clinical trial sponsors, auditors, and study monitors</li></ul>
Requirements and Qualifications<ul><li>
Bachelor&rsquo;s Degree in a scientific or health related field required</li><li>
Two (2) years of related experience in clinical research preferred</li><li>
Ability to work independently and function within a team</li><li>
Strong attention to detail</li><li>
Reliable and able to prioritize competing responsibilities</li></ul>
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&rsquo;s mode of work designation. Complete details about Georgetown University&rsquo;s mode of work designations for staff positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.
Pay Range:
The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:
$20.16 - $31.30
Compensation is determined by a number of factors including, but not limited to, the candidate&rsquo;s individual qualifications, experience, education, skills, and certifications, as well as the University&rsquo;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 accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.
Need some assistance with the application process? Please call 202-687-2500. 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:
GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, 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.</div>

Clinical Research Coordinator 1

Advanced Dermatology and Cosmetic Surgery

SUMMARY
 The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the supervision of the clinical Principal Investigator (PI). The CRC reports directly to the Director of Clinical Research. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES: 
<ul>
<li>Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.</li>
<li>Assists the PI in study feasibility assessments as requested.</li>
<li>Reviews and comprehends the protocol.</li>
<li>Attends investigator meetings as required or requested by the PI.</li>
<li>Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.</li>
<li>Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs and temperature logs.</li>
<li>Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.</li>
<li>Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.</li>
<li>Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.</li>
<li>Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).</li>
<li>Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.</li>
<li>Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.</li>
<li>Develop advertising and other informational materials to be used in subject recruitment.</li>
<li>Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.</li>
<li>Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.</li>
<li>Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol. Prepares the specimens for shipping to laboratory.</li>
<li>Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos. Assures timely completion of Case Report Forms.</li>
<li>Maintains study timelines.</li>
<li>Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. Dispenses study drug to study patients.</li>
<li>Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, and note to file, case report forms, and investigational material accountability forms.</li>
<li>Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.</li>
<li>Retains all study records in accordance with sponsor requirements in Regulatory binder</li>
<li>Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.</li>
<li>Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and policies and procedures.</li>
<li>Arranges secure storage of study documents that will be maintained according to the contracted length of time, whichever is longer.</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES
 <ul>
<li>Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties</li>
<li>Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned</li>
<li>Ability to practice confidentiality and follow HIPAA regulations with patient information</li>
<li>Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization</li>
<li>Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary</li>
<li>Knowledge of medical terminology and ability to use appropriately</li>
<li>Ability to manage time efficiently, prioritize, multi-task, and adapt to change</li>
<li>Ability to maintain high level of accuracy in all documentation and in the performance of all job duties</li>
<li>Ability to perform the essential job duties within the scope of education and training</li>
<li>Skilled in typing/keyboarding; skilled in using computers</li>
</ul>
PROFESSIONALISM
 <ul>
<li>Project a professional manner and image, including proper workplace attire and grooming standards; exhibit professional conduct at all times.</li>
<li>Adhere to ethical principles and core ADCS values; follow all ADCS policies</li>
<li>Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity</li>
<li>Demonstrate initiative and responsibility for actions</li>
<li>Work as an effective team member</li>
<li>Maintain a strong record for attendance and punctuality in arriving at work</li>
<li>Enhance skills through continuing education</li>
</ul>
EDUCATION
 Bachelor's degree in a related field preferred but not required
 LICENSURE/CERTIFICATION REQUIREMENTS
 <ul>
<li>Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP</li>
<li>Good Clinical Practice (GCP) preferred</li>
<li>International Air Transport Association (IATA) Training preferred</li>
</ul>
LANGUAGE/COMMUNICATION REQUIREMENTS
 <ul>
<li>Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals</li>
<li>Ability to write routine reports and correspondence</li>
<li>Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding</li>
<li>Ability to practice professional telephone etiquette and techniques on all calls</li>
</ul>
MATHEMATICAL SKILLS
 The ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
 REASONING ABILITY
 Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
 WORK ENVIRONMENT AND CONDITIONS
 Work is performed in offices and occasionally research sites. Involves frequent telephone and in-person contact with staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work required. Occasional travel required.
 COMPENSATION
 <ul>
<li>401K/PTO/Vacation/Benefit Packages</li>
</ul>
NOTE: This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.

Clinical Research Coordinator - National Harbor, MD

Children's National Hospital

<div></div><div><div>Description<div>
</div>
The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.
<div>
</div></div><div>Qualifications<div></div> 
Minimum Education 
BA/BS degree in a science, technical, health-related field or another applicable 
discipline. (Required) 
 
Minimum Work Experience 
0 years Experience working in a medical or scientific research setting (Preferred) 
 
Functional Accountabilities 
Responsible Conduct of Research 
<ul><li>
Consistently demonstrates adherence to the standards for the responsible conduct of research.</li></ul><ul><li>
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.</li></ul><ul><li>
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.</li></ul><ul><li>
Uses research funds and resources appropriately.</li></ul><ul><li>
Maintains confidentiality of data as required.</li></ul><ul><li>
Meets all annual job-related training and compliance requirements.</li></ul>
Research Administration 
<ul><li>
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.</li></ul><ul><li>
Accurately creates, completes, maintains and organizes study documents.</li></ul><ul><li>
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.</li></ul><ul><li>
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.</li></ul><ul><li>
Attends study meetings, which could include overnight travel, as requested by principal investigator.</li></ul><ul><li>
Works well with other members of the research team and seeks and provides input when appropriate.</li></ul>
Participant Enrollment 
<ul><li>
Adheres to the IRB-approved recruitment plan.</li></ul><ul><li>
Identifies participants that meet eligibility requirements under the supervision of a senior research team member.</li></ul><ul><li>
Screens subjects for eligibility per the protocol and institutional policies.</li></ul><ul><li>
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.</li></ul><ul><li>
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.</li></ul><ul><li>
Engages participants/LARs in the informed consent process according to institutional policies.</li></ul><ul><li>
Follows procedures for documenting participant incentive distribution.</li></ul>
Study Management 
<ul><li>
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.</li></ul><ul><li>
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.</li></ul><ul><li>
Completes accurate IRB submissions within institutional timeframes.</li></ul><ul><li>
Records participant visits in the appropriate tracking system.</li></ul><ul><li>
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.</li></ul>
Data Collection 
<ul><li>
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).</li></ul><ul><li>
Ensures that queries are resolved within sponsor and institutional timelines.</li></ul><ul><li>
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.</li></ul><ul><li>
Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements.</li><li>
Anticipate and responds to customer needs; follows up until needs are met</li></ul> 
Teamwork/Communication<ul><li>
Demonstrate collaborative and respectful behavior</li></ul><ul><li>
Partner with all team members to achieve goals</li></ul><ul><li>
Receptive to others&rsquo; ideas and opinions</li></ul> 
Performance Improvement/Problem-solving<ul><li>
Contribute to a positive work environment</li></ul><ul><li>
Demonstrate flexibility and willingness to change</li></ul><ul><li>
Identify opportunities to improve clinical and administrative processes</li></ul><ul><li>
Make appropriate decisions, using sound judgment</li></ul> 
Cost Management/Financial Responsibility<ul><li>
Use resources efficiently</li></ul><ul><li>
Search for less costly ways of doing things</li></ul> 
Safety<ul><li>
Speak up when team members appear to exhibit unsafe behavior or performance</li></ul><ul><li>
Continuously validate and verify information needed for decision making or documentation</li></ul><ul><li>
Stop in the face of uncertainty and takes time to resolve the situation</li></ul><ul><li>
Demonstrate accurate, clear and timely verbal and written communication</li></ul><ul><li>
Actively promote safety for patients, families, visitors and co-workers</li></ul><ul><li>
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance</li></ul><div>
</div></div><div>
Primary Location: District of Columbia-Washington</div><div>
Work Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010</div><div>
Job: Research</div><div>
Organization: Ctr Clinical &amp; Community Rsrch</div><div>
Position Status: R (Regular) - FT - Full-Time</div><div>
Shift: Day</div><div>
Work Schedule: M-F, 40 hrs per week</div><div>
Job Posting: Apr 8, 2026, 7:23:11 AM</div><div>
Full-Time Salary Range: 42702.4 - 71156.8</div></div>

Clinical Research Assistant

<div>
 The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.
 
 
 
 Minimum Education
 
 
 
 BA/BS degree in a science, technical, health-related field or another applicable
 
 
 discipline. (Required)
 
 
 
 Minimum Work Experience
 
 
 
 0 years Experience working in a medical or scientific research setting (Preferred)
 
 
 
 Functional Accountabilities
 
 
 
 
 Responsible Conduct of Research
 
 
 
 <ul>
 <li>
 Consistently demonstrates adherence to the standards for the responsible conduct of research.
 </li>
 <li>
 Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
 </li>
 <li>
 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.
 </li>
 <li>
 Uses research funds and resources appropriately.
 </li>
 <li>
 Maintains confidentiality of data as required.
 </li>
 <li>
 Meets all annual job-related training and compliance requirements.
 
 
 </li>
 </ul>
 
 Research Administration
 
 
 
 <ul>
 <li>
 Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
 </li>
 <li>
 Accurately creates, completes, maintains and organizes study documents.
 </li>
 <li>
 Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
 </li>
 <li>
 Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
 </li>
 <li>
 Attends study meetings, which could include overnight travel, as requested by principal investigator.
 </li>
 <li>
 Works well with other members of the research team and seeks and provides input when appropriate.
 
 
 </li>
 </ul>
 
 Participant Enrollment
 
 
 
 <ul>
 <li>
 Adheres to the IRB-approved recruitment plan.
 </li>
 <li>
 Identifies participants that meet eligibility requirements under the supervision of a senior research team member.
 </li>
 <li>
 Screens subjects for eligibility per the protocol and institutional policies.
 </li>
 <li>
 Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
 </li>
 <li>
 Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
 </li>
 <li>
 Engages participants/LARs in the informed consent process according to institutional policies.
 </li>
 <li>
 Follows procedures for documenting participant incentive distribution.
 
 
 </li>
 </ul>
 
 Study Management
 
 
 
 <ul>
 <li>
 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.
 </li>
 <li>
 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.
 </li>
 <li>
 Completes accurate IRB submissions within institutional timeframes.
 </li>
 <li>
 Records participant visits in the appropriate tracking system.
 </li>
 <li>
 Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
 
 
 </li>
 </ul>
 
 Data Collection
 
 
 
 <ul>
 <li>
 Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
 </li>
 <li>
 Ensures that queries are resolved within sponsor and institutional timelines.
 </li>
 <li>
 Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
 </li>
 <li>
 Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements.
 </li>
 <li>
 Anticipate and responds to customer needs; follows up until needs are met
 
 
 </li>
 </ul>
 Teamwork/Communication
 
 
 <ul>
 <li>
 Demonstrate collaborative and respectful behavior
 </li>
 <li>
 Partner with all team members to achieve goals
 </li>
 <li>
 Receptive to others&rsquo; ideas and opinions
 
 
 </li>
 </ul>
 Performance Improvement/Problem-solving
 
 
 <ul>
 <li>
 Contribute to a positive work environment
 </li>
 <li>
 Demonstrate flexibility and willingness to change
 </li>
 <li>
 Identify opportunities to improve clinical and administrative processes
 </li>
 <li>
 Make appropriate decisions, using sound judgment
 
 
 </li>
 </ul>
 Cost Management/Financial Responsibility
 
 
 <ul>
 <li>
 Use resources efficiently
 </li>
 <li>
 Search for less costly ways of doing things
 
 
 </li>
 </ul>
 Safety
 
 
 <ul>
 <li>
 Speak up when team members appear to exhibit unsafe behavior or performance
 </li>
 <li>
 Continuously validate and verify information needed for decision making or documentation
 </li>
 <li>
 Stop in the face of uncertainty and takes time to resolve the situation
 </li>
 <li>
 Demonstrate accurate, clear and timely verbal and written communication
 </li>
 <li>
 Actively promote safety for patients, families, visitors and co-workers
 </li>
 <li>
 Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
 
 
 </li>
 </ul>
 
 Primary Location
 
 
 
 District of Columbia-Washington
 
 
 
 Work Locations
 
 
 
 CN Hospital (Main Campus)
 
 
 
 Job
 
 
 
 Research
 
 
 
 Organization
 
 
 
 Ctr Clinical &amp; Community Rsrch
 
 
 
 Position Status
 
 
 
 R (Regular)
 
 
 
 Shift
 
 
 
 Day
 
 
 
 Work Schedule
 
 
 
 M-F, 40 hrs per week
 
 
 
 Job Posting
 
 
 
 Apr 8, 2026, 5:53:11 PM
 
 
 
 Full-Time Salary Range
 
 
 
 42702.4
</div>

<div></div><div><div>Description<div>
</div>
The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.
<div>
</div></div><div>Qualifications<div></div> 
Minimum Education 
Bachelor's Degree BA/BS degree in a science, technical, health-related field or another applicable 
discipline. (Required) 
 
Minimum Work Experience 
0 years Experience working in a medical or scientific research setting (Preferred) 
 
Functional Accountabilities 
Responsible Conduct of Research 
<ul><li>
Consistently demonstrates adherence to the standards for the responsible conduct of research.</li></ul><ul><li>
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.</li></ul><ul><li>
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.</li></ul><ul><li>
Uses research funds and resources appropriately.</li></ul><ul><li>
Maintains confidentiality of data as required.</li></ul><ul><li>
Meets all annual job-related training and compliance requirements.</li></ul>
Research Administration 
<ul><li>
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.</li></ul><ul><li>
Accurately creates, completes, maintains and organizes study documents.</li></ul><ul><li>
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.</li></ul><ul><li>
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.</li></ul><ul><li>
Attends study meetings, which could include overnight travel, as requested by principal investigator.</li></ul><ul><li>
Works well with other members of the research team and seeks and provides input when appropriate.</li></ul>
Participant Enrollment 
<ul><li>
Adheres to the IRB-approved recruitment plan.</li></ul><ul><li>
Identifies participants that meet eligibility requirements under the supervision of a senior research team member.</li></ul><ul><li>
Screens subjects for eligibility per the protocol and institutional policies.</li></ul><ul><li>
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.</li></ul><ul><li>
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.</li></ul><ul><li>
Engages participants/LARs in the informed consent process according to institutional policies.</li></ul><ul><li>
Follows procedures for documenting participant incentive distribution.</li></ul>
Study Management 
<ul><li>
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.</li></ul><ul><li>
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.</li></ul><ul><li>
Completes accurate IRB submissions within institutional timeframes.</li></ul><ul><li>
Records participant visits in the appropriate tracking system.</li></ul><ul><li>
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.</li></ul>
Data Collection 
<ul><li>
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).</li></ul><ul><li>
Ensures that queries are resolved within sponsor and institutional timelines.</li></ul><ul><li>
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.</li></ul><ul><li>
Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements.</li><li>
Anticipate and responds to customer needs; follows up until needs are met</li></ul> 
Teamwork/Communication<ul><li>
Demonstrate collaborative and respectful behavior</li></ul><ul><li>
Partner with all team members to achieve goals</li></ul><ul><li>
Receptive to others&rsquo; ideas and opinions</li></ul> 
Performance Improvement/Problem-solving<ul><li>
Contribute to a positive work environment</li></ul><ul><li>
Demonstrate flexibility and willingness to change</li></ul><ul><li>
Identify opportunities to improve clinical and administrative processes</li></ul><ul><li>
Make appropriate decisions, using sound judgment</li></ul> 
Cost Management/Financial Responsibility<ul><li>
Use resources efficiently</li></ul><ul><li>
Search for less costly ways of doing things</li></ul> 
Safety<ul><li>
Speak up when team members appear to exhibit unsafe behavior or performance</li></ul><ul><li>
Continuously validate and verify information needed for decision making or documentation</li></ul><ul><li>
Stop in the face of uncertainty and takes time to resolve the situation</li></ul><ul><li>
Demonstrate accurate, clear and timely verbal and written communication</li></ul><ul><li>
Actively promote safety for patients, families, visitors and co-workers</li></ul><ul><li>
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance</li></ul><div>
</div></div><div>
Primary Location: District of Columbia-Washington</div><div>
Work Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010</div><div>
Job: Research</div><div>
Organization: Ctr Clinical &amp; Community Rsrch</div><div>
Position Status: R (Regular) - FT - Full-Time</div><div>
Shift: Day</div><div>
Work Schedule: M-F, 40hrs/week</div><div>
Job Posting: May 8, 2026, 10:57:41 AM</div><div>
Full-Time Salary Range: 42702.4 - 71156.8</div></div>

CCRM Fertility

<div>Come join CCRM Fertility, a global pioneer in fertility treatment, research, science, specializing in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction and egg donation. As a member of CCRM Fertility&rsquo;s diverse team of professionals, you will be a part of helping families grow and changing lives. We take pride in providing our employees with meaningful employment, a supportive culture, and a well-balanced personal &amp; work life alignment. For more information, visit www.ccrmivf.com
Location Address: 8010 Towers Crescent Dr., Suite 500, Vienna, VA / 2120 L. St NW, Suite 701, Washington DC 20037
Department: Clinical
Work Schedule: Monday &ndash; Friday (7:00am &ndash; 3:00pm)
What We Offer Our Team Members:
<ul><li>Generous Paid time-off (PTO) and paid holidays</li><li>
Medical, Dental, and Vision Insurance</li><li>
Health benefits eligible the first day of the month following your start date.</li><li>
401(k) Plan with Company Match (first of the month following 2 months of service)</li><li>
Basic &amp; Supplement Life Insurance</li><li>
Employee Assistance Program (EAP)</li><li>
Short-Term Disability</li><li>
Flexible spending including Dependent Care and Commuter benefits.</li><li>
Health Savings Account</li><li>
CCRM Paid Family Medical Leave (eligible after 1 year)</li><li>
Supplemental Options (Critical Illness, Hospital Indemnity, Accident)</li><li>
Professional Development, Job Training, and Cross Training Opportunities</li><li>
Bonus Potential</li><li>
401(k) Plan with Company Match (first of the month following 2 months of service)</li><li>
Professional Development, Job Training, and Cross Training Opportunities</li><li>
Potential for Over-time Pay (Time and a half)</li><li>
Holiday Differential Pay (Time and a half)</li><li>
Weekend Shift Differential Pay ($4.00 per hour)</li></ul>
What You Will Do: The Clinical Coordination Assistant demonstrates knowledge and skill in the care of all infertility patients and works with the IVF Nurse Coordinator to facilitate care for the CCRM patients. This position reports directly to the Clinical Manager and takes daily direction from the Nurse Coordinators/Physician/Clinical Manager and Practice Administrator.<ul><li>
Transcribe, enter, scan, and verify data from source documents into the electronic medical record in an accurate and timely manner.</li><li>
Place daily lab orders as directed by RN.</li><li>
Obtain prior authorizations for medications as directed by RN.</li><li>
Call patient pharmacy with patient prescriptions and prescription refills as directed by RN.</li><li>
Perform chart audits for weekly ART meeting.</li><li>
Track and audit all patient consent forms for completion. Alert RN if deficiencies noted.</li><li>
Verify that patient work up status is completed and ensure communicable labs are kept up to date.</li><li>
Track inventory and ensure timely documentation of all incoming and outgoing consignment medication for nurse team, as needed or as delegated.</li><li>
Attend hormone meeting with the nursing team.</li><li>
Assist with monitoring nurse team flags and facilitate flag completion as needed.</li><li>
Assist with answering calls to nurse line and checking nurse line voicemails as needed or when delegated.</li><li>
Within scope of practice, answer triaged phone calls for nursing team and document action taken in patient EMR.</li><li>
Other duties as assigned.</li></ul><div>
What You Bring:</div><ul><li>
High School Diploma required.</li><li>
Medical Assistant certificate required.</li><li>
Current BLS certification required.</li><li>
2+ years of medical assistant experience preferred.</li></ul>
Working Conditions: The physical demands described here are representative of those which should be met, with or without reasonable accommodation (IAW ADA Guidelines), by an employee to successfully perform the essential functions of this job. This job operates in a professional office, clinical and/or laboratory setting. This role routinely uses standard office equipment such as computers, including computer keyboards and mice; telephones; photocopiers; scanners; filing cabinets. While performing the duties of this job, the employee will interact with others and ensure compliance with medical regulations, ethical guidelines, and organizational policies to maintain the highest standards of care and patient and staff safety.<div>
CCRM&rsquo;s Compensation: The salary range represents the national average compensation for this position. The base salary offered will vary based on location, experience, skills, and knowledge. The pay range does not reflect the total compensation package. Our rewards may include an annual bonus, flexible work arrangements, and many other region-specific benefits.</div>
Pre-Employment Requirements: All offers of employment are conditional upon the successful completion of the CCRM Fertility onboarding process, including verification of eligibility and authorization to work in the United States. This employer participates in the E-Verify Program in order to verify the identity and work authorization of all newly hired employees.
Equal Employment/Anti-Discrimination: We are an equal-opportunity employer. In all aspects of employment, including the decision to hire, promote, discipline, or discharge, the choice will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.</div>

Clinical Coordination Assistant

EDJ Associates, Inc.

<div>
 
 Department:
 
 Research
 
 
 
 Location:
 
 National Institue of Health - Washington DC Area
 
 
 
 Description
 
 
 
 
 CONTINGENT HIRE NOTICE:
 
 This position is a contingent hire. Employment is contingent upon EDJ Associates, Inc. receiving a contract award. This position is performed primarily on-site at NIH headquarters in Bethesda, Maryland. Applicants must be able to obtain and maintain a security clearance from the federal government.
 
 
 The Documentation Specialist I develops and maintains standard operating procedures (SOPs), user guides, training materials, wiki content, presentations, and website content for the CTRO. This role ensures all documentation meets quality standards, supports Section 508 accessibility compliance, and provides proofreading and finalization of IT documentation.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Develop, update, and maintain Standard Operating Procedures (SOPs) in the NCI wiki repository.
 </li>
 <li>
 Prepare and maintain systems, programming, and operations documentation, including user reference manuals.
 </li>
 <li>
 Develop training materials, PowerPoint presentations, and website content for CTRO-related activities.
 </li>
 <li>
 Maintain, update, and manage content on the CTRO wiki hosted within the NCI environment.
 </li>
 <li>
 Proofread documentation for grammar, spelling, formatting, and compliance with NCI standards.
 </li>
 <li>
 Ensure all deliverable products comply with Section 508 accessibility requirements.
 </li>
 <li>
 Support the development and distribution of Clinical Trials Reporting Program (CTRP) correspondence and Listserv communications.
 </li>
 <li>
 Maintain the internal documentation library and provide document control/tracking services.
 </li>
 <li>
 Compose and finalize IT documentation, including specifications and user manuals, in the style and format required by the task.
 </li>
 <li>
 Coordinate with Government and contractor staff to develop related documentation.
 
 
 </li>
 </ul>
 
 Skills, Knowledge And Expertise
 
 
 
 <ul>
 <li>
 One to three (1&ndash;3) years of experience in documentation, technical writing, or a related discipline.
 </li>
 <li>
 Knowledge and understanding of all aspects of proofreading, including grammar and spelling.
 </li>
 <li>
 Experience preparing technical documentation, user guides, and training materials.
 </li>
 <li>
 Familiarity with Section 508 accessibility standards.
 </li>
 <li>
 Strong organizational skills and attention to detail.
 </li>
 <li>
 Ability to obtain and maintain a Level 1 (Non-Sensitive) NACI background investigation.
 
 
 </li>
 </ul>
 
 Tools and Technologies:
 
 
 
 <ul>
 <li>
 Microsoft Office Suite (Word, Excel, PowerPoint)
 </li>
 <li>
 Wiki/content management systems (e.g., Confluence, SharePoint)
 </li>
 <li>
 Adobe Acrobat or similar PDF tools
 </li>
 <li>
 Section 508 compliance checking tools
 </li>
 </ul>
</div>

Documentation Specialist I

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