Clinical Research Coordinator

Duke Careers•Durham, NC

13d•$61,026 - $101,959•Onsite

About The Position

This position will serve as the primary coordinator for clinical studies in the Division of Hematology. As the Clinical Research Coordinator, you will conduct clinical research studies, with a focus on Sickle Cell Disease, as well as serve as back up for studies as needed. You will be responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.), and will work with the lead coordinator to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.). You will have an essential role in the recruitment and support of research participants with serious medical illness.

Requirements

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

Nice To Haves

Organizational skills
Communication skills
Ability to handle multiple assignments simultaneously
Technology skills
Medical terminology
Understanding of clinical medicine
Must be able to flex with the demand of work schedules and timelines.
Must demonstrate excellent attention to detail.
Must be able to manage, work with, and support multiple stakeholders with different practice styles in a productive manner, and willing to learn new and complex skills as needed.
Must be resourceful, able to work independently, and to problem-solve on a daily basis.
Duke clinical trial experience and a desire to expand their knowledge and to share knowledge in an academic setting.

Responsibilities

Conduct clinical research studies, with a focus on Sickle Cell Disease, as well as serve as back up for studies as needed.
Responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.).
Work with the lead coordinator to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.).
Recruitment and support of research participants with serious medical illness.
Recognizes when typical agreements (MTA, CDA, DUA, DTA, etc.) are necessary and alerts appropriate parties.
Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation.
Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).
Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
Serves as the primary liaison with sponsors, IDS, and other parties as necessary.
Follows protocol schema for randomization and blinding/unblinding.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects findings.
Maintains all participant level documentation for studies that are greater than minimal risk or complex in nature (e.g., procedural and interventional studies).
Employs strategies to maintain retention rates.
Evaluates processes to identify problems with retention.
Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.
Escalates issues.
Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies).
Develops or helps develop SOPs.
Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Conducts activities for study visits in compliance with the protocol.
Contributes to the effective facilitation of team meetings to achieve predetermined objectives.
May lead multidisciplinary meetings with various stakeholders.
Identifies all AEs, and determines whether or not they are reportable.
Collaborates with the PI to determine AE attributes, including relatedness to study.
Conducts and documents consent for participants for all types of studies, including those that are greater than minimal risk or complex in nature and/or require any orders in Maestro Care.
Develops consent plans and documents for participants in a variety of studies.
Develops and submits documentation for IRB review in iRIS.
Communicates with the IRB staff and reviewers and handles issues appropriately.
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Enters and collects research data.
Develops research data entry or collection tools.
Ensures accuracy and completeness of data for all studies, including those that are greater than minimal risk or complex in nature.
Recognizes data quality trends and escalates as appropriate.
Recognizes and reports security of physical and electronic data vulnerabilities.
May develop or review data lifecycle and management plans for multiple study protocols.
Demonstrates and applies open science practices and the FAIR data principles.
Prepares data for deposit in repositories following publication or study closeout.
Locates and follows repository-specific requirements to submit study data for sharing.
May draft data sharing plans for clinical studies that ensure data and documentation will support re-use.
Maps a protocol's data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
Innovatively uses technology to enhance a research process.
Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.
Assists with or contributes to the development of funding proposals.
Independently conducts literature searches and reviews.
Develops elements of research protocols using scientific proposals from the PI.
Contributes to the development of scientific publications or presentations.
Serves as an author on poster presentations or publications.
Prepares for, coordinates, and actively participates in site visits.
Communicates effectively with sponsors and/or CROs.
Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking of financial milestones, and all aspects of study visits.
Uses required EHR functionalities to manage participants and study visits.
Uses OnCore and eREG systems and system reports to manage research protocols.
Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
May make feasibility recommendations.
For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
May forecast effort needs.
Ensure that studies are conducted in compliance with institutional requirements and other policies.
Follows, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).
Prepares studies for closeout and document storage.
Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.
Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.
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.
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.