Clinical Research Specialist, Sr.

Duke Careers•Durham, NC

1d•$21 - $31•Onsite

About The Position

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.

Requirements

Associate's degree.
One year of relevant experience.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience.

Responsibilities

Assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering) and prepares for study monitoring and audit visits.
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.
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.
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.
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.
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.
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.
Under supervision, 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.
Assists with simple literature searches.
Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).
Provides some contribution to scientific publications or presentations. (no authorship)
As directed, attends or schedules site visits and assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Records participant accrual information and consent documentation for minimal risk studies, and basic protocol information in clinical research management system.
For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
Follows protocol specific systems and process flows.
Works with the manager to understand areas of opportunity and develop a training plan.
Takes training courses and applies the knowledge and skills.
May also train others in the skills learned.
Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).
Communicates with other study personnel as required for study implementation and routine problem resolution.