CLINICAL RESEARCH COORDINATOR

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

Duke’s Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Coordinator who will be part of the Duke Perinatal Research Center located at 2608 Erwin Road, Suite 210, Durham, NC 27705.

More information about the center is located at the following link: https://obgyn.duke.edu/research/active-research-programs/duke-perinatal-research-center

100% Grant funded

This position will include study activities for a wide array of obstetrics studies including, but not limited to drug trials, vaccine trials, observational studies, and on occasion some gynecology studies involving contraception or other drugs. These studies range from observational to blinded randomized controlled trials. There is a strong emphasis on working as a team and the importance of being flexible in day to day tasks. This position also requires that the employee be part of the team's on-call pool to cover sample management during after-hours situations (rotating weekend on call).

Spanish fluency preferred, phlebotomy experience preferred. This individual may train or oversee others in the tasks below. The preferred candidate will possess the ability to work independently, on multiple tasks and as part of a team.

Work Performed

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). . Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.

- Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering).

- 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.

- Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for complex studies (e.g., procedural and interventional studies).

- Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).

- Schedules participants for research visits (excluding those requiring HER access). 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.

Ethics

- Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. 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.

- 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 reviewers and handles issues appropriately. .

- Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. .

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 RDSPs for multiple study protocols.

- Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). .

- Learns and uses new technology when required.

Science/Study and Site Management

- Demonstrates a basic understanding of the elements of research study designs.

- 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, including minimum footprint, calendars, tracking/marking financial milestones, and all aspects of study visits.

- 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.

- Ensures that 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, shippingextrasupplies back to sponsor).

Leadership

- Maintains Duke and project specific training requirements.

- 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.

Required Qualifications at this LevelEducation/Training

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.

Skills

Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

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: 10/16/2020
Application Due: 1/14/2021
Work Type:
Salary: