CLINICAL RESEARCH COORDINATOR

Duke University’s Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Coordinator in their Urogynecology division. Urogynecology is a medical discipline focused on pelvic floor issues including vaginal prolapse, bladder control issues, bowel control issues, and recurrent urinary tract infections. 

Occupational Summary 

Given the breadth of our research program, we are looking to add an additional research coordinator to our experienced team. We are specifically looking for a highly motivated, team-oriented individual to integrate into several NIH-funded and industry-funded trials. 

This is an in-person position which will require rotating days between our two clinical offices (one in Durham and one in Raleigh). Research experience preferred and an actively engaged research team participant. 

Operations: 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 in all processes and procedures. 

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. 

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 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. May train or oversee others. 

Employ 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). May train or oversee others. 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. Ethics: 

Identifies all Adverse Events, and determines whether or not they are reportable. Collaborates with the PI to determine Adverse Event 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. Data: 

Enters and collects basic data for research studies. May score scripted or validated tests and measures. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. 

Follows required processes, policies, and systems to ensure data security and provenance. Knowledgeable about requirements for depositing data and following 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. Science: 

May assist with simple literature searches under supervision from PI or CRC. Study and Site Management: 

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. May train others. 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. May forecast effort needs. 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. 

Leadership: 

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. 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. 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.