CLINICAL RESEARCH COORDINATOR, SR

Location
Durham, NC
Posted
Dec 21, 2018
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH COORDINATOR, SR
Population Health Sciences



NOTE: This position is 100% sponsored research and is a term position (once funding ends the position ends unless there is continued funding).

Operations
Screen participants independently and provide oversight and training to study team members who screen participants. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion. Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc. Oversee maintenance of subject level documentation. Implement innovative solutions to maximize recruitment and retention Conduct and document consent for participants in a variety of studies independently and provide training to others in these tasks. Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings. Oversee the collection of adverse event information Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.

Ethics
Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Assist others with application of these principles. Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs). Coordinate efforts of external monitoring boards. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

Data
Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Independently design ECRFs and EDCs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each. Recognize and report vulnerabilities related to security of physical and electronic data. Suggest and implement solutions to vulnerabilities related to security of data and data provenance Independently investigate issues related to accuracy and completeness of data. Develop and run queries and reports. Recognize trends related to data quality and escalate as appropriate. Develop and follow SOPs for data QA. Monitor QA of study data. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)

Science
Conduct literature reviews independently Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims Develop research proposals or protocols with little assistance; Identify operational shortcomings of proposals and protocols. Summarize and interpret study results, and determine application to future study procedures.

Leadership
Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group. Encourage career development by actively seeking out continuing education opportunities for self and study team members. Participate in scientific presentations and publications. Serve as expert mentor to junior staff. Establish and assign the activities of multiple teams to accomplish study goals. Lead study teams with regard to clinical research professional guidelines and code of ethics. Identify potential problems and risks to the participant, study, investigator, team, sponsor, and institution. Maintain training requirements and 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.

Study and Site Management
Determine and implement alternative solutions to accomplishing recruitment and retention milestones. Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expenses route in a timely manner; troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets. Use system reports to ensure unit, division, or department compliance with institutional requirement/policies; assist team members with understanding these requirements and policies. Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Lead site initiation activities Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.Coordinate operational plans for multiple research studies. Develop and implement closeout procedures for multiple studies, unit, department, or division.

Communication
Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members. Take an active role in including others in decision-making.

Type of Research
Our research is housed in the Department of Population Health Sciences and involves behavioral interventions to improve medication adherence and clinical outcomes. This job includes the management of multiple protocols, regulatory/IRB submissions, as well as patient recruitment and data collection. This job also includes management of other research staff members.



Requisition Number
401534885

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1202 CLINICAL RESEARCH COORDINATOR, SR

Job Family Level
53

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.

Special Skills
Some management experience is preferred; experience with designing surveys and databases within RedCap


Auto req ID

108236BR

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.

PI106402912

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