CLINICAL RESEARCH COORDINATOR - Obstetrics/Gynecology

Job description

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

100% Grant funded

Duke University has an open position as a Clinical Research Coordinator in its Obstetrics and Gynecology department in the Gynecology/Oncology Division.

This position will work with Gynecology Oncology research populations on studies that are typically minimal risk. This position interacts with other Gynecology Oncology coordinators, MDs, fellows, residents and medical students. The position may be required to travel to other clinic locations in Durham and Raleigh area.

Operations:

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

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.

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.

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 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 and plans for complex study visits. Participates in study team meetings.

May train and oversee others in all processes and procedures.

Ethics:

Identifies all adverse events (AE), and determines whether or not they are reportable. Collaborates with the Principal Investigator (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 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.

May train and oversee others in all processes and procedures.

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. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies.

Follows SOPs for quality assurance. Runs summaries and reports on existing data. Recognizes and reports security of physical and electronic data vulnerabilities.

May develop or review RDSPs for multiple study protocols. Independently uses and implements technology to enhance productivity or process. May train and oversee others in all processes and procedures. Science: 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 Clinical Research Organizations.

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 Electronic Medical Record functionalities to manage participants and study visits.

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 complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast staffing needs.

Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. Prepares studies for closeout and document storage.

May train and oversee others in all processes and procedures.

Leadership:

Proactively seeks opportunities to add relevant skills and certifications to own portfolio.

Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).

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. Other duties as assigned.


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.

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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Job No:
Posted: 1/13/2021
Application Due: 4/13/2021
Work Type: Full Time
Salary: