Clinical Research Specialist, Sr

Clinical Research Specialist, Sr.

Performs a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator (CRC) or similar Clinical Research Unit (CRU), Oversight Organization (OO) designee. Participates in day to day operations related to the collection, compilation, and documentation of clinical research data and may train Clinical Research Specialists (CRSs) in these tasks.

Research Operations Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering) and prepares for study monitoring and audit visits. Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Maintains participant level documentation for minimal risk studies, as defined by Institutional Review Board (IRB).

Recruits research participants according to study protocol and follows SOPs and strategies to manage and retain research participants. Screens participants in person or over the phone for minimal risk studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

Assists with establishing and maintaining study level documentation; may perform for international studies. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents minimal risk study visits and scripted testing or interviews. May manage participant payment. Follows standard operating procedures SOPs and participates in study team meetings.

Safety and Ethics Recognizes known potential adverse events (AEs), identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in minimal risk studies. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. This position does not have access in the EHR to tee up orders for second signature in Maestro Care.

Assists with the development of consent plans and documents for participants and compiling documents needed for regulatory and safety reporting to sponsors and other agencies. Under supervision develops and submits documentation and information for IRB review.

Data Enters and collects basic data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate, or missing data for minimal risk studies and follows SOPs for quality assurance (QA). Runs summaries and reports on existing data. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision. Follows required processes, policies, and systems to ensure data security and provenance.

In addition, recognizes and reports security of physical and electronic data vulnerabilities. Follows requirements for depositing data into an appropriate repository, meta data specifications for data sharing, and the use of data standards for developing research databases. (E.g. ICD 10, CDISC, MedDRA, and WHODrug). With guidance, locates and follows repository specific requirements to submit study data for sharing. Learns and uses new technology when required.

Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop reports on study progress for the Principal Investigator (PI) and other study team members and collaborators. Executes testing process after the completion of a build, or following any project changes or system upgrades. May conduct some testing and documentation for Part 11 projects.

Scientific Concepts Assists with…