CLINICAL RESEARCH COORDINATOR, SR

Location
Durham, NC
Posted
Jun 15, 2018
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH COORDINATOR, SR
Reproductive Endocrinology & Fertility

This position will coordinate and manage clinical research studies investigating problems in female and male infertility, gynecologic and male reproductive system diseases and disorders that impact fertility, problems in andrology and endocrinology affecting reproduction.

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. May conduct study visits independently.

Serve as a the division's resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Improve systems related to specimen handling.

May collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.

Describe the various steps involved in handling Investigational Product (IP) and sssist with management of IP including arrival, storage, handling including requesting requisitions, inventory, and reordering.

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.

Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.

Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc.

Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).

Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.

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.

Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority.

Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs).

Coordinate efforts of external monitoring boards.

Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.

Data:

Use EDC systems and enter data accurately and train others in these tasks.

Detect issues related to data capture, collection or management and suggest solutions.

Use required processes, policies, and systems to ensure data security and provenance.

Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.

Recognize when data agreements are necessary.

Leadership:

Encourage and support colleagues in completing project work.

Assist research colleagues in identifying efficiencies and improving process.

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.

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:

Make recommendations to investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies.

Provide 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.

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.

Take part in site initiation/closeout visits as directed.

Assist with the development of protocol- specific systems and documents including process flows, standard operating procedures, and case report forms.

Prepare for closeout and document storage

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.

Description of Portfolio and Clinical Responsibilities:

Manage the research portfolio by employing strategies to reach established short- and long-term goals.

Monitor milestones using relevant reports.

Investigate trends and implement modifications to improve the research program effectiveness.

Ensure that institutional communications are shared with staff within the division.

Maintain communication with own division and other departments/offices to accomplish portfolio objectives.

Monitor adherence to and update manuals of operations.

Act as liaison with business and grant personnel, medical team and research staff.



Requisition Number
401435315

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.

Special Skills: Phlebotomy

Preferred Experience: Women's Reproductive Health Research Experience

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

Auto req ID

101750BR

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.

PI102948786

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