Clinical Research Specialist, Sr

Be You.

This full-time onsite Clinical Research Professional (CRP) will participate in research conducted by the Division of Nephrology and Endocrinology in the Department of Medicine under the supervision of the Principal Investigator(s) of the Nephrology and Endocrinology Research Programs. This CRP will perform a variety of research, data, and clerical duties to support conduct of clinical research under direct daily supervision of Clinical Research Coordinator Sr. (CRC) or Clinical Research Unit (CRU) designee. CRP duties may include screening, EMR review, consenting to minimal risk studies, conducting subject visits, study and site documentation, data collection, sample collection/processing/shipping, query resolution, participant payment processing, filing, data extraction and reporting, scheduling and order/manage supplies. The CRP will be integrated into a larger clinical research team and is expected to collaborate on studies that will further the research mission of the research program. This position will report to the CRC Sr..The Principal Investigators will provide supervision, regulatory oversight, mentorship, and guidance in the conduct of research.

Minimum Requirements: 

Education/Training

Work requires an Associate's degree.

Experience

One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of required experience.

Skills

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

This position is:

• Onsite

Be Bold.                                       

As a Clinical Research Specialist, Sr., you will perform a variety of research, data, and clerical duties to support the conduct of clinical research under the supervision of a Clinical Research Coordinator Sr. (CRC), Principal Investigators or Clinical Research Unit (CRU) designee. You will participate in day to day non-complex clinical research operations, collect, compile, and document clinical research data while ensuring regulatory compliance, participant safety and data integrity.

What You'll Do:

Operations: Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Assists with study level documentation and approvals for international studies. Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for minimal risk (e.g., questionnaire, data registry, scripted) studies. Follows SOPs and strategies to manage and retain research participants. Recruits research participants according to study protocol. 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. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. 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. Participates in study team meetings.

Ethics: Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in minimal risk studies, as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Assists with the development of consent plans and documents for participants. Under supervision, develops and submits documentation and information for IRB review. Assist with the compilation of documents needed for regulatory and safety reporting to sponsors and other agencies

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. Follows SOPs for quality assurance. Runs summaries and reports on existing data. 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 and meta-data specifications for data sharing. 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 reports on study progress for the 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.

Science: Assists with or contributes to the development of funding proposals. Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations.

Study and Site Management: Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Records participant accrual information and consent documentation for minimal risk studies in clinical research management system. Records 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. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership: 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.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary  to get work done efficiently. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives

Choose Duke.