Clinical Research Coordinator

Duke Careers•Durham, NC

8d•$61,026 - $101,959•Onsite

About The Position

The Duke Vaccine and Trials Unit (DVTU) conducts, primarily, vaccine research across all age groups. The DVTU mission is to evaluate strategies aimed at the prevention, treatment, and control of human infectious diseases, assess the safety and effectiveness of new and existing vaccines, and further our understanding of measures of protection from infection.

Requirements

Completion of an Associate’s degree.
Work requires a minimum of two years of relevant research experience.
Completion of DOCR North Caroline state approved Clinical Research Apprenticeship program may substitute for one year of required experience.
A Bachelor’s degree may substitute for 2 years required experience.

Nice To Haves

Responsibilities

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
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 participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
Employs strategies to maintain retention rates.
Evaluate 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 complex studies (e.g., procedural and interventional studies).
Develops or helps develop SOPs.
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
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 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 and information for IRB review.
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 data.
Develops data entry or collection SOPs or tools.
Assists with quality control and data cleaning as directed.
Independently responds to queries created by a CRO or the data manager.
Ensures accuracy and completeness of data for all studies, including those that are 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.
Learns and uses new technology when required.
Provides some contribution to scientific publications or presentations (no authorship).
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 financial milestones, and all aspects of study visits.
Uses required EMR functionalities to manage participants and study visits.
Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information.
For studies with 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.
Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).
Prepares studies for closeout and document storage.
Works with the manager to understand areas of opportunity and develop a training plan.
Takes training courses and applies the knowledge and skills.
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.
Demonstrates interpersonal skills to get work done efficiently.
Recognizes and escalates organizational issues that could be optimized to improve research process.
Demonstrates resilience and is adaptive to change.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.