Durham, NC, US
3 days ago
CLINICAL RESEARCH COORDINATOR

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.

 

 

 

This position is for a Clinical Research Coordinator within the Duke Neonatal-Perinatal Research team and will support projects involving families and neonates. The position will work with multiple investigators and other members of the team on clinical research studies. Biological samples will be collected and processed from neonates/parents per protocol. The responsibilities and duties will require this position to primarily work in person with some opportunities for hybrid local remote work.


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.

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. Follows SOPs and strategies to manage and retain research subjects. 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 and information for IRB review. Communicates with the IRB staff 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.

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. 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. 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. Prepares 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 collaborators.

Science:
Assists with or contributes to the development of funding proposals. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations.  Serves as an author on poster presentations or publications.

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. May train others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. 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. 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). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

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. Navigates processes 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 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.


Research Activities: (Effort 60%)

Provide clinical research coordination and implementation for assigned pediatric neonatal-perinatal clinical research projects Provide support on federally funded multi-site clinical research projects including the Neonatal Research Network Consent patients to assigned studies including but not limited to interventional, observational, and retrospective research Collect and process collected samples and prepare for cold storage or shipping per protocol. Complete School of Medicine and Sponsor electronic study management systems, including but not limited to iRIS, OnCore, MaestroCare Collect and review clinical data as needed per protocol and enter into appropriate clinical report form (CRF/eCRF) Conduct initial study eligibility screening and review with PI Collect and process research samples, including biologics Laboratory processing and shipping of research samples Participate in team meetings, providing updates to PI and team Provide routine updates to PI’s and study team

 

Regulatory Support: (Effort 10%)

Prepare regulatory submissions through approval for multiple studies and maintain regulatory files through the life cycle of the study Participate in monitoring visits, resolving all issues identified by the sponsor or its representative Communicate with sponsor on behalf of PIs regarding all regulatory and study startup processes Maintain regulatory binders for assigned projects Develop and submit documentation and information for IRB review Communicate with the IRB staff and reviewers and handle issues appropriately Prepare required progress reports for federally funded research projects Prepare draft budgets in support of study start-up and clinical research unit (CRU) feasibility assessments Coordinate submission of CRU scientific and financial feasibility review documents
 

Data: (Effort 30%)

Ensure the accurate and timely collection of protocol identified data Collect clinical data as needed per protocol and enter into appropriate CRF/eCRF Ensure data security and integrity in alignment with School of Medicine requirements Ensure timely entry of data into study established databases

 

Type of Research:

This position will work on industry and federally funded neonatal/perinatal clinical research protocols including those that are complex in nature. The candidate should be able to work independently on individual studies and within a team.

Special skills:
Prior experience with federally funded clinical research or neonatal experience preferred but not required.

 

Education

 

 

Completion of an Associate' s degree

 

Experience

 

Work requires a minimum of two ye ars of relevant research experience. ABachelor's degree may substitute for 2 years required experience.

 

 

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $ 58,656.00 to USD $98,000.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as w ell as market and organizational considerations when extending an offer.

 

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https: //hr.duke.edu/benefits/

 

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.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

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.

 

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