CLINICAL RESEARCH COORDINATOR

Operations:

• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

• Knowledgeable in regulatory and institutional policies and processes; applies them appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes.

• 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. May train others.

• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer and addressing findings. May train others.

• Maintains participant-level documentation for all studies, including complex ones (e.g., procedural and interventional studies) that require access to the Duke EHR. May train or oversee others.

• Employs strategies to maintain retention rates and evaluates processes to identify problems with retention. May train or oversee others.

• Develops strategies to maintain recruitment rates and evaluates processes to identify problems, escalating issues as necessary. May train or oversee others.

• Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others.

• Develops or helps develop SOPs. May train or oversee others.

• Collects, prepares, processes, ships, and maintains the inventory of human research specimens, especially those requiring complex procedures. May train or oversee others.

• Maintains study-level documentation for all studies, including complex ones. May train or oversee others.

• Conducts study visits in compliance with the protocol and may train staff.

• Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Ethics:

• Identifies all AEs and determines whether they are reportable, collaborating with the PI to determine AE attributes, including relatedness to the study. May train or oversee others.

• Conducts and documents consent for participants for all study types, including those that are complex in nature and/or require orders in Maestro Care. May train or oversee others.

• Develops consent plans and documents for various studies. May train or oversee others.

• Develops and submits documentation for IRB review in iRIS, communicates with IRB staff and reviewers, and handles issues appropriately. May train or oversee others.

• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

• Enters and collects data, developing data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data.

• Ensures accuracy and completeness of data for all studies, including complex ones. Recognizes data quality trends and escalates as appropriate.

• May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security vulnerabilities of physical and electronic data.

• May develop or review data lifecycle and management plans for multiple study protocols.

• Maps a protocol's data flow plan, including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others.

• Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/programs, as relevant.

• Independently performs data cleaning and management tasks for complex protocols, such as merging multiple datasets, recoding and scoring scales, imputing data, and creating datasets for analysis.

• Provides oversight and training and lends expertise to multiple study teams.

• Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators.

• Creates clear visualizations to help communicate key information to stakeholders.

Science:

• Uses expertise in research design to provide significant contributions to protocols or research proposals.

Study and Site Management:

• Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.

• Uses clinical research management systems and their reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.

• Uses required EMR functionalities to manage participants and study visits. May train others.

• Uses OnCore and eREG systems and system reports to manage research protocols. May train or oversee others.

• Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations.

• Ensures ample supplies and that equipment is in good working order for studies with supplies or equipment. May forecast effort needs and train or oversee others.

• Ensures studies are conducted in compliance with institutional requirements and other policies, following and potentially developing or implementing operational plans (e.g., protocol-specific systems and documents including process flows). May train or oversee others.

• Prepares studies for closeout and document storage. May train or oversee others.

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 offerings (e.g., Research Wednesday, RPN, events outside of Duke) and applies learned material to the job. May disseminate information to others.

• Serves on committees and workgroups internal to Duke or externally in the therapeutic area of research.

• Demonstrates interpersonal skills to get work done efficiently, recognizing and escalating organizational issues that could be optimized to improve the research process.

• Demonstrates resilience and adaptability to change.

• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.

• Communicates effectively with others, regardless of reporting relationships, to accomplish shared work objectives.

Description of Portfolio Responsibilities: (Effort .%):

Description of Clinical Responsibilities:

Clinical responsibilities:

Type of Research:

This position will support complex interventional trials within the Division of Cardiothoracic Surgery, mostly device trials, with the possibility of drug trials down the line.

Special Skills:

This position requires someone with strong research knowledge (not necessarily in the CT space, but would be a bonus) as they will be involved in more complex coordination.

Minimum Qualifications:

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our success depends on the robust exchange of ideas—an exchange that is best when the diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all community members feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All community members have a responsibility to uphold these values.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $58,656.00 to USD $98,000.00. Duke University considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, and market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provisions for requests for reasonable accommodation will be provided by each hiring department.

Education:

• Completion of an Associate's degree.

Experience:

• Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years of required experience.