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For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. 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. 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 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. 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 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). Provides oversight and training and lends expertise to multiple study teams. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews.May manage participant payment. Participates in study team meetings.
Identifies all AEs and determines whether or not they are reportable.Collaborates with the PI to determine 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 MaestroCare. 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 and information for IRB review. Communicates with the IRBstaff 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.
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. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance. In addition, it recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required.
Assists with simple literature searches. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship).
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. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, 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.
Works with the manager to understand areas of opportunity and develop a training plan. Take training courses and apply the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN,additional training, etc.). 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 sha red work objectives.
Description of Portfolio Responsibilities: (Effort. %):
Description of Clinical Responsibilities:
Type of Research:
This position will manage pediatric nephrology clinical research studies which may be complex in nature. Serve as the primary CRC to operationalize, oversee and manage Phase I to IV clinical research trials and registries involving all ages within the pediatric population and adults
Requires person with strong organizational skills, good time management and ability to work with patients & their families. Experience with a pediatric population is an asset but not a requirement. Good communication and leadership skills. Able to manage multiple studies.
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.