Experience:
3-5 years of experience
Concerned about your lack of experience? Learn More...
Employment Type:
Full time
Posted:
3/13/2018
Job Category:
Research
Industry:
Health Care & Medicine
Senior Clinical Research Coordinator
(This job is no longer available)
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Job Description

Qualifications

 Minimum Education
Bachelor's Degree


Minimum Work Experience
3 Year(s)

Specific Requirements and Preferences
  • Bachelor's degree with 3 years of relevant experience
  • Master's degree with 2 years of relevant experience



Required Skills/Knowledge
Knowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple, complex activities while maintaining close attention to detail and not losing site of the organizational mission. Interpersonal skills which demonstrate formal and informal leadership in a diverse professional environment. 


Functional Accountabilities

Conduct of Research

 

  1. Demonstrates consistent adherence to the standards for responsible conduct of research.
  2. 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.
  3. Maintains knowledge and comprehension of assigned research protocols; including study procedures, timelines and eligibility.
  4. 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.
  5. Cooperates with sponsor, institutional and federal monitoring/auditing activities. Then, collaborates with study team in formulating responses to findings.
  6. Uses and accounts for research funds and resources at his/her performance level. This includes assisting with clinical trial budgets, and reconciling research subject billing.
  7. Reviews and develops a familiarity with the clinical trial agreement, contract or grant award terms to ensure compliance with all terms and conditions.
  8. Complies with and maintains current documentation of all job-related training and conflict of interest reporting.
  9. Reports good faith suspicions of research noncompliance and/or research misconduct to the appropriate institutional compliance office(s).

Participant Enrollment

  1. Adheres to the IRB approved recruitment and enrollment plan.
  2. Screens subjects for eligibility per the protocol and institutional policies.
  3. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
  4. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose, participation details and to assess participation interest.
  5. Engages participants/LARs in the informed consent process according to institutional policies.

Study Management

  1. Conducts/participates in feasibility assessments to ensure that adequate sight resources and infrastructure are available for protocol participation.
  2. 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.
  3. 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.
  4. Authors study submissions and related documents, based on functional role. This may include 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.
  5. Registers and records participant visits in the appropriate tracking system.
  6. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.
  7. Works well with other members of the research team. This includes appreciating multiple workplace diversities and seeking and providing input, when appropriate.
  8. Coordinates, prepares for and responds to oversight body routine visits and audits.
  9. Attends study meetings (which could include overnight travel) as requested by the PI

Data Collection 

  1. 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).
  2. Ensures that queries are resolved within sponsor and institutional timelines.
  3. Plans and performs (if assigned) research specimen collection, labeling, and storage/shipping. Maintains accurate sample accountability/chain of custody documentation.
  4. Ensures secure storage of study documents.

 

Other Responsibilities

  1. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center.
  2. Directs the work of a Clinical Research Assistant and Clinical Research Coordinator, as assigned.
  3. Identifies and resolves issues and challenges with appropriate input and oversight.

 

 

About Children's National Health System

Childrens National Medical Center is the only exclusive provider of pediatric care in the metropolitan Washington area and is the only freestanding childrens hospital between Philadelphia, Pittsburgh, Norfolk, and Atlanta. Serving the nations children for more than 130 years, Childrens National is a proven leader in the development and application of innovative new treatments for childhood illness and injury.

Childrens National is proudly ranked consistently among the best pediatric hospitals in America by US News & World Report.

Our Culture

Children's mission is to be preeminent in providing pediatric health care services that enhance the health and well-being of children regionally, nationally and internationally. Through leadership and innovation, Children's creates solutions to pediatric healthcare problems. Children's excels in Care, Advocacy, Research, and Education to meet the unique needs of children, adolescents and their families. Children's leadership realizes that our employees are the heart of our medical center and the soul of our mission. One of our greatest assets is the diversity of our workforce, which adds to the richness of our culture. Teamwork, dedication, and professionalism are essential values and characteristics that make our employees unique.

Childrens internationally recognized team of pediatric healthcare professionals care for more than 360,000 patients each year who come from throughout the region, nation and world. Our employees share a sense of pride and commitment to the patients and families we serve. We aspire to provide patients and their families with the highest quality of care and service in a family-centered environment. In essence, we are a team of "Great People Providing Great Care."

Nursing Students

As a nursing student, you might already be craving hands-on experience at a highly respected hospital. You may be thinking about where or with which population you want to work after graduation.

At Childrens, a world-class teaching hospital and internationally-recognized leader in pediatric health, we invite nursing students at all stages of learning to explore the real world of working in a hospital setting and experience first-hand the challenges and rewards of this career.

Internship Program

The internship program provides the novice nurse with the knowledge base and skill set needed to transition to competence in clinical nursing practice. While providing the needed skills to meet the organization goals and mission, the program provides nurses with the leadership skills to work collaboratively within a multidisciplinary team. The program bridges the gap between undergraduate education and real-life professional nursing practice, delivering state-of-the art pediatric care.

The program is offered to new graduate nurses from an accredited nursing program with a passion for children. All new graduates, with less than one-year acute care experience, are eligible to participate in the program after obtaining licensure.