Clinical Research Assistant

Location
WASHINGTON, District of Columbia-WASHINGTON
Posted
Sep 01, 2021
Closes
Oct 06, 2021
Ref
210002NA
Function
Analyst, Research
Industry
Healthcare
Hours
Full Time
Our team is seeking an enthusiastic and motivated individual for a research assistant position to support a community-engaged quality improvement project to address inequities in health care.

The successful candidate will bring passion for the work and will be responsible for the recruitment of stakeholders (patients, families, clinicians), coordination of focus groups, stakeholder engagement meetings, education/training events, and community advisory board meetings, dissemination of work, and draft meeting minutes. The assistant will work as part of a highly collaborative team dedicated to addressing health care disparities.

We are specifically looking for candidates with the following qualifications:

Strong verbal and written communication skills and organizational skills with attention to detail

Ability to work closely with a diverse team including community stakeholders, investigators, and research staff

Commitment to addressing disparities and improving healthcare delivery

Performs a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. Develops progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations, when applicable. Identifies participants that meet eligibility requirements, under the supervision of a senior research team member. Prepares necessary documents, equipment, supplies, etc. for research visits. Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies under direction. Maintains subject level documentation for minimal risk studies, or for other studies under direction. Follows procedures for documenting participant incentive distribution. Assists in maintaining regulatory documents per sponsor and institutional requirements. Plans and coordinates research specimen collections and shipping.

Qualifications

Minimum Education

B.A. Bachelor's or equivalent combination of experience and education. BA/BS degree in a science, technical, health-related field or another applicable discipline. (Required)

Functional Accountabilities

Responsible Conduct of Research
  • Demonstrates consistent adherence to the standards for responsible conduct of research.
  • Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects' research and use of protected health information.
  • Maintains knowledge and comprehension of assigned research protocols; including study procedures, timelines and eligibility.
  • Creates, accurately completes, maintains and organizes study documents. 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.
  • Cooperates with sponsor, institutional and federal monitoring/ auditing activities. May collaborate with study team in formulating responses to findings.
  • Uses and accounts for research funds and resources at his/her performance level. This includes reconciling research subject billing, if assigned.
  • Complies with and maintains current documentation of all job-related training and conflict of interest reporting.
  • Reports good faith suspicions of research noncompliance and/or research misconduct to the appropriate institutional compliance office(s).


Participant Enrollment
  • Adheres to the IRB approved recruitment and enrollment 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, participation details and to assess participation interest.
  • Engages participants/LARs in the informed consent process according to institutional policies.


Study Management
  • 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 .
  • Completes accurate IRB submissions within institutional timeframes.
  • Records participant visits in the appropriate tracking system.
  • Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.
  • Works well with other members of the research team. This includes appreciating multiple workplace diversities and seeking and providing input, when appropriate.
  • Attends study meetings (which could include overnight travel) as requested by the PI


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


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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