CLINICAL RESEARCH COORDINATOR, SR

Location
Durham, NC
Posted
Oct 12, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH COORDINATOR, SR
Medicine-Nephrology

Work Performed

1. Clinical research operations.
  • Provide oversight and training to team members who screen, schedule, consent, and collect adverse event information for participants in a variety of studies.
  • Provide oversight and training to team members who maintain subject level documentation, including documentation in the electronic medical record.
  • Serve as a resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans.
  • Evaluate processes to identify issues related to recruitment and retention, and implement innovative solutions to maximize recruitment and retention.
  • Create, optimize, and oversee systems related to research specimens and train others in these tasks. Provide direction for preparation of study monitoring/audit visits and correct findings.
  • Develop IRB documents and train other staff in these tasks.
  • Train staff to maintain exemplary documentation.
  • Design best methods for management of IP for drug, device, and biologic studies.
  • Oversee implementation of, and compliance with, the required systems for IP for sponsored protocols.
  • Serve as an expert resource for study teams, DUHS procurement, billing, and compliance for the proper handling of IP. Coordinate necessary agreements.
  • Direct study teams' compliance with appropriate collection of AE information per protocol, and provide input for adverse event reports.
  • Serve as a resource to junior staff and the department or division with regard to institution and sponsor-specific reporting requirements.
2. Ethical and participant safety considerations.
  • Provide division or department-wide training in ethical conduct of research.
  • Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
  • Articulate the reasoning for an individual protocol's inclusion and exclusion criteria. Independently develop documents related to safety and security.
  • Serve as an expert resource for development and implementation of RDSPs, DSMPs, and Conflict of Interest plans across multiple studies or study teams.
3. Data management and informatics.
  • Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Independently design CRFs to collect data according to protocol.
  • Select methods of data capture and implement at the unit level.
  • Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data.
  • Oversee the creation and use of queries, summaries, and reports.
  • Develop system/framework for QA processes for multiple studies or for entire unit.
  • Develop quality assurance systems for research data; ensure that QA SOPs are updated and followed by study teams. Implement quality assurance systems across multiple studies, or across entire unit, department or division.
  • Recognize and report vulnerabilities related to security of physical and electronic data; recommend and lead implementation of processes, policies, and systems to ensure data security and data provenance.
  • Map protocol data flow and predict areas of vulnerability.
  • Determine solutions for vulnerabilities in data flow plans for multiple studies.
  • May implement at unit level.
4. Scientific concepts and research design.
  • Train others in the basic concepts of study design.
  • Conduct and synthesize literature reviews, and independently develop proposals or protocols.
  • Assess and determine solutions for operational shortcomings of proposals and protocols.
  • Identify and collaborate with various stakeholders to ensure adequate design, implementation, and testing of study aims. 5.Leadership and professionalism.
  • Assist research colleagues in identifying efficiencies and improving process.
  • May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups.
  • Network and encourage leadership opportunities for staff within a small work group.
  • Lead a committee or task force.
  • Actively seek out continuing education opportunities for self and study team members. Independently lead scientific or programmatic presentations and publications.
  • Assign, review, and train individual staff and multiple study teams.
  • Employ escalation and performance plans as needed. Serve as expert mentor to junior staff.
  • Establish and assign the activities of multiple teams to accomplish study goals.
  • Provide constructive feedback to team members. Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics.
  • Identify potential problems and risks to the participant, study, and institution.
  • Maintain Duke and project specific training requirements.
  • Develop solutions to proactively ensure unit, department, or division compliance with training requirements.
  • Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research. 6.Study and site management.
  • Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expensed route in a timely manner; troubleshoot, escalate, and resolve issues.
  • Collaborate with the financial analyst to establish financial monitoring systems.
  • Coordinate with financial teams, PRMO, etc.
  • Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets.
  • Coordinate operational plans for multiple research studies.
  • Develop systems and documents including process flows, training manuals,and SOPs to be used unit, department, or division-wide.
  • Work with sponsors/study teams to arrange required training.
  • Lead site initiation, monitoring, and closeout visits and activities; provide feedback to the study team members.
  • Develop and implement closeout procedures for multiple studies, unit, department, or division.
  • Inform investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies.
  • Determine and implement alternative solutions to accomplish recruitment and retention milestones.
  • Use system reports to ensure unit, division, or department compliance with institutional requirements and other policies; assist team members with understanding these requirements and policies.
  • Oversee study teams' maintenance of Delegation of Authority Logs and training of KP on study specific duties.
7. Communication and team science.
  • Lead team meetings.
  • Include others in decision-making, and escalate issues appropriately.
  • Communicate with sponsors, subcontractors, or vendors and take action when communication has stalled.
  • Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Maintain training requirements.
  • Develop solutions to proactively ensure study team members' compliance with training requirements.
  • Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
  • Make recommendations to investigative team.

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

Requisition Number
401338737

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1202 CLINICAL RESEARCH COORDINATOR, SR

Job Family Level
53

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University 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 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.

Education

Work requires one of the following:
1. Completion of a Bachelor's degree and a minimum of four years of research experience
2. Completion of an Associates degree plus a minimum of six years of research experience
3. Completion of a Master's degree and a minimum of 2 years of of research experience

Auto req ID

94292BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at 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.

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