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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Clinical Research Coordinator - Conradt

This position will help coordinate the day-to-day operations of assign ed studies within the Duke Child Adaptation and Neurodevelopment Lab. Ca ndidate will be primarily recruiting and running study visits for a stud y recruiting pregnant Latina and African American women to assess the ef fects of racism and discrimination on birth outcomes. The candidate may also be developing study materials for new and/or pilot studies, for ins tance on studies examining the neurodevelopment of infants with congenit al heart disease.

While pri marily remote, study needs require the ability to come in-person to our Durham office location for occasional onsite meetings as well as to cond uct participant sessions at relevant time points; a flexible schedule al lowing for evening and weekend availability for participant sessions is required.

Operations:. Ideal candidate recognizes when typic al agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts ap propriate parties and is knowledgeable in regulatory and institutional p olicies and processes; applies appropriately in study documentation, pro tocol submissions, and SOPs. May train others in these policies and proc esses. 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 a nd interventional studies) and/or require access to the Duke EHR. May tr ain or oversee others. Employ strategies to maintain retention rates. Ev aluate processes to identify problems with retention. May train or overs ee others. Employs and may develop strategies to maintain recruitment ra tes 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. Dev elops or helps develop SOPs. May train or oversee others. Maintains stud y level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or ov ersee others. Conducts activities for study visits incompliance with th e protocol. May train staff. Contributes to the effective facilitation o fteam meetings to achieve predetermined objectives. May lead multidisci plinary meetings with various stakeholders.

Ethics: Identifies all AEs, and det ermines whether or not they are reportable.Collaborates w ith the PI to determine AE attributes, including relatedness to study on prenatal exposure to racism. May train or oversee others. Conducts and documents consent for participants for all types of studies, including t hose that are complex in nature and/or require any orders in Maestro Car e. May train or oversee others. Assists with the development of consent plans and documents for participants. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and rev iewers and handles issues appropriately. May train or oversee others.

Data: Und er direct supervision from Biostatistician and PI may perform basic anal yses on structured data. Enters and collects data.Develop s data entry or collection SOPs or tools. May provide oversight or train ing to study team members collecting or entering data. Assists with qual ity control and data cleaning as directed. Independently responds to que ries created by a CRO or the data manager. Independently corrects and do cuments incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existi ng data. Learns and uses new technology when required. Under supervision , assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating reports on study progress for the PI and other study team members and collaborat ors.

Science: Assists with simple literature searches. Under guidance, develops elements of research protocols for simple studies (e.g., registries, su rvey studies). Demonstrates a basic understanding of the elements of res earch study designs. Contributes to the development of scientific public ations or presentations.Serves as an author on poster pre sentations or publications.

Study and Site Management: As directed, attends or schedules site visits. Records participant accrual information and conse nt documentation for non-complex studies in clinical research management system. Uses clinical research management system and its reports to man age all protocol activities, including minimum footprint, SIP counsel, a nd all aspects of maintaining current protocol information. May train ot hers. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Ensure t hat studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sp onsor).

Leadership: Works with the manager to understand areas of opportunity a nd develop a training plan. Takes training courses and applies the knowl edge and skills. May also train others in the skills learned. Keeps curr ent with research updates by attending key external departmental meeting s (i.e. Research Wednesday, RPN, additional training, etc.). Navigates p rocesses and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to c hange. Communicates effectively with others, regardless of reporting rel ationship, to accomplish shared work objectives.

Description of Portfolio Responsibilities: (Effort .75%): Assist lead coordinator on the Generational Learning to Optimize Wellness (GLOW) study on recruitment, data collecti on (study interviews, collection of prenatal heart rate data, management of dyadic interaction tasks), data management, and management of underg raduate research assistants.

(Effort .25%): Assist PI with study investigating the neurodevelopment of infants with congenital heart disease. Maintain regulatory documenta tion and assist with scheduling of sessions with participants and PI; as sist with data entry and data processing.

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Special skills: Bilingual preferred. Experience with or willingness to learn REDCap sof tware is required.

Minimum Qualifications

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 required experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity 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.

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Essential Physical Job Functions: Certain jobsat Duke University and Duke University Health System may include essential job 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.