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Lead Clinical Research Coordinator

1 month ago

Silver Spring, United States Children's National Medical Center Full time

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.

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.

Teamwork/Communication

Performance Improvement/Problem-solving

Cost Management/Financial Responsibility

Safety

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