Lead Clinical Research Coordinator
Company: Children's National Hospital
Location: Rockville
Posted on: May 26, 2023
Job Description:
The Lead Clinical Research Coordinator independently leads and
oversees day-to-day operations of clinical research studies
conducted by a principal investigator with minimal supervision.
This individual 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. The Lead Clinical Research Coordinator may directly
supervise a limited number of Clinical Research Coordinators or
other research staff.
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 5
years of relevant research experience. (Required) Or
Master's Degree Master's degree with at least 4 years of relevant
research experience. (Required) Or
Doctor of Philosophy (Ph.D.) Doctoral degree with at least 2 years
of relevant research experience. (Required)
Minimum Work Experience
5 years At least five years of experience with a bachelor's degree.
(Required) Or
4 years At least four years of experience with a master's degree.
(Required) Or
2 years At least 2 years of relevant research experience with a
doctoral 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), Certified Clinical Research Associate through
the Association of Clinical Research Professionals (ACRP) 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 and organizes study
documents.
- 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.
- Works well with other members of the research team and seeks
and provides input when appropriate.
- Serves as an effective liaison between the investigators,
sponsors, hospital departments involved in research studies and the
Clinical Research Center. 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.
- Attends study meetings, which could include overnight travel,
as requested by principal investigator. 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. Leadership
- Performs and/or provides input for employee performance
evaluations and disciplinary actions.
- Identifies and resolves issues and challenges with appropriate
input and oversight.
- Serves on institutional committee as assigned. Other
Responsibilities
- Leads a variety of unit, department, or division-level research
initiatives.
- 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.
- 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.
Keywords: Children's National Hospital, Rockville , Lead Clinical Research Coordinator, Healthcare , Rockville, Maryland
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