Lead Clinical Research Coordinator

Silver Spring, Maryland-Silver Spring
Mar 24, 2021
Apr 28, 2021
Analyst, Research
Full Time
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


Minimum Education
Bachelor's Degree

Specific Requirements and Preferences
Experience as a study coordinator or a data manager for an investigator-initiated clinical trial is strongly desired. (Required)

Specific Requirements and Preferences
Bachelor's degree with >5 years of relevant research experience, or
Master's degree with >4 years of relevant research experience, or
Doctoral degree with >2 years of relevant research experience (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 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 preparing accurate and complete 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, 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.
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. Arranges 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. Performs and/or provides input for employee performance evaluations and disciplinary actions.
4. Serves as time-keeper for supervised employees.
5. Identifies and resolves issues and challenges with appropriate input and oversight.
6. Serves on institutional committees as assigned.

Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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