CLINICAL RESEARCH COORDINATOR

Duke Careers • Durham, NC

1d

About The Position

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.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. Knowledgeable in regulatory and institutional policies and processes;  applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. 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, primarily those requiring complex procedures. May train or oversee others. 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 AEs, and determines whether or not they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. 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. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. 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. May train or oversee others. Data:Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Science:Assists with or contributes to the development of funding proposals. Assists with simple literature searches. Develops elements of research protocols using scientific proposals from the PI. Uses expertise in research design to provide significant contribution 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 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 OnCore and eREG systems and system reports to manage research protocols. May train or oversee others. Makes feasibility recommendations for multiple study teams/research program.  Develops and oversees processes to determine participation in trials. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across multiple study teams or sites. 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 (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. Actively facilitates and leads multiple study teams' adoption of change in their working environment. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Description of Portfolio Responsibilities: (Effort .%): Description of Clinical Responsibilities:Clinical responsibilities: •  Type of Research:This position will lead several complex protocols for the EM CRU and will require being on call. We approach participants daily based on ED demands and have a variety of protocols from simple questionnaires to investigational drugs Special skills:Spanish-speaking will be a plus, but 

Nice To Haves

• Spanish-speaking will be a plus

Responsibilities

• 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).
• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and 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 participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR.
• 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 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 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 data.
• Develops data entry or collection SOPs or tools.
• Assists with or contributes to the development of funding proposals.
• Assists with simple literature searches.
• Develops elements of research protocols using scientific proposals from the PI.
• Uses expertise in research design to provide significant contribution to protocols or research proposals.
• 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 OnCore and eREG systems and system reports to manage research protocols.
• Makes feasibility recommendations for multiple study teams/research program.
• Develops and oversees processes to determine participation in trials.
• For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
• May forecast effort needs.
• For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.
• Oversees implementation of operational plans across multiple study teams or sites.
• 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.
• Actively facilitates and leads multiple study teams' adoption of change in their working environment.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed