Children's National Health System


Lead Clinical Research Coordinator (44395863)
Location: Washington, District of Columbia - United States
Posted: 1/16/2018

Lead Clinical Research Coordinator

Leads and oversees day-to-day operations of clinical research studies conducted by a principal investigator.
Leads a variety of unit, department, or division-level research initiatives. May directly supervise a limited number of Clinical Research Coordinators or other research 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.
Provides direction to study teams regarding protocol development and study conduct. Directs and prepares for study monitoring visits or audits.
Responds to and formulates corrective action plans for audit/monitor findings. Requires previous significant, substantive experience at the Clinical Research Coordinator level.
Demonstrates day-to-day accountability and provides direct administration for larger or more complex projects.
Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Requires minimal supervision, often working independently


Qualifications

Minimum Education:
Bachelor's Degree
Specific Requirements and Preferences:
Bachelors degree with 5 years of relevant research experience, or
Masters degree with 4 years of relevant research experience, or
Doctoral degree with2 years of relevant research experience

Required Skills/Knowledge:
IMPACT DC (“Improving Pediatric Asthma Care in the District of Columbia”) is a pediatric asthma program, dedicated to improving asthma care and outcomes for children through clinical care, education, research, and advocacy.
The IMPACT DC Asthma Clinic Coordinator will be primarily responsible for facilitating the day-to-day activities of the IMPACT DC Asthma Clinic.
This includes coordinating staffing, training, scheduling, quality assurance, planning and reporting, and facilitating study recruitment. The Clinic Coordinator will collaborate with a diverse team of research assistants, clinicians, coordinators, and administrators to assure continued success and growth.
The coordinator will also provide asthma education for participating families, and will connect families with individualized resources. He/she will perform other duties such as data entry, in addition to being responsible for selected administrative duties such as filing and record keeping, photocopying, creating flyers and posters and maintaining clinic and study records.
This position requires significant prior project management experience. The individual will be responsible for the overall coordination of large and complex projects and perform a variety of activities including team supervision, project management, data management and reporting, and administrative/clerical duties in support of clinical operations. The coordinator will have responsibility for directing the work of multiple staff members. The coordinator will be able to work independently with minimal supervision within the context of a highly collaborative team.
This position requires the ability to manage multiple responsibilities and activities with close attention to detail, effective interpersonal skills, ability to communicate with a diverse group of individuals, strong knowledge of clinical research, and familiarity with databases, data collection and analysis.
We are specifically seeking candidates with the following qualifications:
Strong project management skills, and ability to track project deliverables and communicate progress under tight timelines

Ability to work closely with a diverse team including community stakeholders, investigators, clinical research staff, and national experts

Ability to work both independently with minimal supervision and in a highly collaborative team setting that values a broad range of perspectives

Commitment to patient empowerment and improving healthcare delivery and outcomes

Supervisory experience preferred

Spanish language fluency preferred

Required Licenses and Certifications:
- Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA), Certified Clinical Research Associate through the Association of Clinical Research Professionals (ACRP) or equivalent research certification is required for internal candidates.

- External candidates are required to obtain research certification within one year of hire.
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 materials. 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 preparing accurate and complete clinical trial budgets, and 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:
Conducts/participates in feasibility assessments to ensure that adequate sight resources and infrastructure are available for protocol participation.
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 submissions and related documents, including research protocols, informed consents, protocol specific source documents, IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications (if needed) and scholarly presentations and publications.
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 PI
Data Collection:
Assures that data is collected as required by the 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 (if assigned) research specimen collection, labeling, and storage/shipping. Maintains accurate sample accountability/chain of custody documentation.
Arranges secure storage of study documents.
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 and Clinical Research Coordinator, as assigned
Performs and/or provides input for employee performance evaluations and disciplinary actions.
Serves as time-keeper for supervised employees.
Identifies and resolves issues and challenges with appropriate input and oversight.
Serves on institutional committees as assigned.

Primary Location: District of Columbia-Washington

Work Locations: Sheikh Zayed Campus 111 Michigan Avenue Washington 20010
Job: Non-Clinical Professional
Organization: Ctr Clinical & Community Rsrch
Regular / Temporary: R (Regular)
Position Status: FT - Full-Time
Shift: Day
Work Schedule: M-F

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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