Children's National Health System


Clinical Research Coordinator (44338687)
Location: Washington, District of Columbia - United States
Posted: 1/16/2018

Clinical Research Coordinator

Participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator.
Performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data.
May direct the work of junior staff.
Attains progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations, when applicable.
Follows procedures for documentation of study payments and participation incentives.
Employs strategies to recruit and retain research participants .
Assists participants with individual needs.
Maintains regulatory documents as per sponsor and institutional policies.
Independently coordinates conducts and documents study assessments according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for all types of studies.
May provide training to personnel.
Ensures compliance with protocol guidelines and requirements of regulatory agencies.
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.
Prepares for study monitoring or study audit visits.
Performs query resolution and assists with addressing and correcting audit findings.
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Works with sponsor representatives.
Reviews current literature to obtain information relevant to clinical research program, as directed.


Qualifications

Minimum Education:
Bachelor's Degree
Specific Requirements and Preferences:
BA/BS degree in a science, technical, health-related field or another applicable discipline
Minimum Work Experience:
1 Year(s)
Specific Requirements and Preferences:
1 Year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population)

Other Responsibilities:
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center.
Directs the work of a Clinical Research Assistant, as assigned.
Responsible Conduct of Research:
Demonstrates consistent adherence to the standards for responsible conduct of research.
Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects; research and use of protected health information.
Maintains knowledge and comprehension of assigned research protocols; including study procedures, timelines and eligibility.
Creates, accurately completes, maintains and organizes study documents. Accounts for study materials.
This may include, but is not limited to participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s), and participation incentives.
Cooperates with sponsor, institutional and federal monitoring/ auditing activities. Then, collaborates with study team in formulating responses to findings.
Uses and accounts for research funds and resources at his/her performance level. This includes reconciling research subject billing.
Reviews and develops a familiarity with the clinical trial agreement, contract or grant award terms to ensure compliance with all terms and conditions.
Complies with and maintains current documentation of all job-related training and conflict of interest reporting.
Reports good faith suspicions of research noncompliance and/or research misconduct to the appropriate institutional compliance office(s).
Participant Enrollment:
Adheres to the IRB approved recruitment and enrollment 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.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose, participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies
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.
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 to meet organizational objectives and deadlines in a timely manner.
Works well with other members of the research team. This includes appreciating multiple workplace diversities and seeking and providing input, when appropriate.
Coordinates, prepares for and responds to oversight body routine visits and audits.
Attends study meetings (which could include overnight travel) as requested by the P
Data Collection:
Assures that data is collected as required by the protocol and in accordance with research data principles (Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs (if assigned) research specimen collection, labeling, and storage/shipping. Maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.

Primary Location: District of Columbia-Washington
Work Locations: Sheikh Zayed Campus 111 Michigan Avenue Washington 20010
Job: Non-Clinical Professional
Organization: Cntr for Cancer_ Blood Dsordrs
Regular / Temporary: R (Regular)
Position Status: FT - Full-Time
Shift: Day
Work Schedule: M-F; Day Shift

Additional Requirments / Information

Job Capacity:Employee (full-time)
Minimum Education Level:See Job Description
Visa Sponsorship: No
Related Industries:Other

At Children's, we know what it takes to really connect with kids, we're looking for nurses who love a challenge.


Pediatric nurses have to be patient. They have to be understanding, yet able to communicate effectively and honestly with a child and their family about their illness and treatment. And every Children's nurse must have the confidence to take a patient's care into his or her own hands.


At Children's you'll work closely with each patient and their family across a continuum of care - beginning with admission, when you perform physical assessments and take a patient/family history that covers all the vitals.


You'll prepare and carry out a plan of patient care. You'll work with professionals from all Children's health care disciplines. Together you will ensure your patients' progress every step of the way. You will even make rounds with physicians, discussing your patients' conditions and needs.


Professionally, you'll grow like never before.


The nursing practice environment at Children's is ideal for developing your skills to the maximum, increasing your level of responsibility and entering new specialty areas.


Our versatile career ladder, the Program for Professional Advancement (PPA), enables you to move both vertically and laterally across a wide range of clinical, educational and management opportunities. Recently we restructured our nurses compensation package to include:

  • Flexible Scheduling

  • Tuition Assistance

  • Professional Development

  • Clinical Ladder

  • Continuing Education Conferences (local, regional, national)

  • Weekend Incentive Program

  • Exceptional Differentials

  • Preceptorship and Charge Nurse Recognition

  • Certification and Degree Recognition Bonus

  • Collaborate with Internationally-Acclaimed

  • Medical Leaders

  • Pediatric Nursing Fellowships (PICU, NICU, Hematology/Oncology)

  • AND MORE!



Our recent achievement of Magnet status reflects what we’ve known all along: That our nurses are something very special - that their vision, talents, dedication and leadership define a truly exceptional practice environment. We invite you to learn more about our Magnet environment, accomplished by approximately 6% of the nation’s hospitals, and even fewer pediatric centers.



We are also a Beacon Award winner, recognized for our outstanding CICU and PICU environments. In fact, our Pediatric Cardiac Intensive Care Unit is the first in the country to be designated a Beacon Award winner AND our Pediatric Intensive Care Unit is the first in the Northeast region to receive the Beacon designation!

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* If you would like to find out more about this position or this particular hospital, please click on the 'Information' button. We realize that you may need further information even if you are not ready to apply for a job at this time.

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