Clinical Research Coordinator

Duke University is an academic medical center conducting interdisciplinary biomedical and clinical research through Duke Health and its School of Medicine. The Clinical Research Coordinator will support or lead day-to-day operations of clinical research studies in Gastroenterology, including participant recruitment and consent, study visits, regulatory documentation, specimen management, data collection, and collaboration with investigators, sponsors, and clinical staff.

Responsibilities

Participate in research conducted by the Division of Gastroenterology in the Department of Medicine under the supervision of the Principal Investigators (PIs) of the Gastroenterology Research Program

Perform a variety of research and duties including consenting, enrollment, conducting subject visits, study and site documentation, data entry etc in compliance with sponsor, regulatory, and institutional guidelines, collaborating with physicians and nurses/clinic staff to obtain the specimen, processing/management/shipment of samples to support the conduct of clinical research

Other tasks may include EMR review, participant screening, IP management, query resolution and participant payment processing

Collaborate on studies that will further the research mission of the Gastroenterology program

Participate in or lead day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) at Duke Health; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data

May oversee the work of junior staff and train or mentor others in clinical research tasks

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, 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)

May train or oversee others

Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs)

Assists with study level documentation and approvals for international studies

Is 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

May train staff

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

May provide oversight or training to study team members collecting or entering research data

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

May develop tools for, and train others in, data quality assurance procedures

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

Demonstrates a basic understanding of the elements of research study designs

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

May disseminate information to others

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

Benefits

Comprehensive medical and dental care programs for eligible team members.

Generous retirement benefits for eligible team members.

A wide array of family-friendly and cultural programs for eligible team members.

Company

AI and health data science for medicine and healthcare delivery

Durham, North Carolina, USA

http://www.duke.edu/

Founded in 1924

10001+ employees

Qualifications

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)

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.

Required skills

Represents the skills you have, click on the tags

Experience

2+ years