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Sr Clinical Research Coordinator

4 months ago

Washington, United States Children's National Hospital Full time
The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator 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. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned.

Qualifications:
Minimum Education
Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) Or
Master's Degree Master's degree with at least 2 years of relevant experience (Required)

Minimum Work Experience
3 years At least 3 years of experience with a bachelor's degree. (Required) Or
2 years At least 2 years of experience with a master's degree. (Required)

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 sight of the organizational mission.
Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.

Required Licenses and Certifications
Internal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required)
External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (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 guidances (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, organizes and 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.
  • Attends study meetings, which could include overnight travel, as requested by principal investigator.
  • Works well with other members of the research team, appreciates a diverse workplace 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.
  • Identifies and resolves issues and challenges with appropriate input and oversight.
  • Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs.
  • Creates standard operating procedures (SOPs), and implements operational plans.
  • Provides oversight and training to study team members for a variety of studies.
  • Develops study documents, including consent forms and protocols.
Participant Enrollment
  • Adheres 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.
  • 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.
Study Management
  • Conducts/participates in feasibility assessments to ensure adequate site 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 based on functional role; this may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications 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.
  • Coordinates, prepares for and responds to routine oversight body visits and audits.
  • Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks.
Data Collection
  • 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.
Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
  • 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