CLINICAL RESEARCH ASSOCIATE II - DCRI Clinical Operations

Location
Durham, NC
Posted
Sep 21, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH ASSOCIATE II - DCRI Clinical Operations
DCRI - Site Support & Management

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

*** Experienced CRA with at least one year of travel monitoring experience. Must be able to independently perform monitoring duties at multiple sites and projects.

Occupational Summary:

Perform routine and moderately complex on-site and in-house site assessments independently for clinical trials research. Perform complex on-site and in-house site assessments with direction. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Collect, document, update, and report study information according to procedures and timelines. Create new and customize existing templates and processes to meet project needs with some direction. Follow up, resolve, and report on issues identified during study monitoring and assessment activities with minimal to no direction.

Job Responsbilities & Tasks:

Oversee and review routine and moderately complex site activities for clinical trials research, with minimum or no guidance, through monitoring activities, including on-site visits and/or in-house assessments, including telephone contact and other technologies, according to the trial-specific monitoring plan to assess protocol, regulatory, and SOP compliance with guidance from experienced CRA or clinical trial lead.
a. May travel up to 80% to perform on-site monitoring visits, including site selection, initiation, periodic, and close out visits.
b. Independently perform monitoring activities for multiple sites
and possibly multiple projects, identifying and reporting deviations from regulations and SOPs. Assess protocol and
regulatory compliance, including but not limited to source document verification, informed consent process and human subject protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files.
c. Assess adequacy of site personnel and facilities for study conduct.
d. Provide study training and guidance to designated site
personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Identify Subject safety and data integrity issues and retrain site personnel accordingly.
e. Identify action items and discuss with appropriate site personnel. Communicate routine and unusual
findings to trial supervisor. Document ongoing follow-up and resolution of issues.
f. Assist sites with preparation for planned and unannounced audits with some guidance.
g. Perform trial supervisory activities as directed by trial project leader with approval of line manager.

Independently document routine site management and clinical monitoring activities, site communication, and trial related activities.
a. Apply knowledge of protocol and study documents and processes, during monitoring activities.
b. Regularly review and update study and site status information and enter updates into required systems.
c. Independently prepare monitoring reports for multiple sites.
d. Maintain essential trial and site communication records, electronic and hard copy, removing non-essential communication as directed.
e.Develop and implement action plans for resolution of routine and complex site and study issues

Manage and review routing and moderately complex site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established practices, with minimal to no guidance.
a. Review specified patient data and source documents. Appropriately report safety concerns, protocol deviations and unexpected data trends.
b. Review data status reports and follow-up with sites regarding missing and/or late data.
c. Provide training for site personnel on appropriate source documentation, CRFcompletion, data procedures and timelines, and query resolution. Review data queries, assist sites with query resolution and follow up on outstanding queries.

Build and maintain effective working relationships with site personnel, and internal and external study contacts.
a. Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance.
b. Provide timely notification to appropriate study contacts of site status and trial related needs.
c. Provide clear direction to site and trial personnel as directed while following project guidelines and professionally representing the DCRI and the DCRI's clients.
d. Contribute to positive team dynamics through effective listening and verbal communication including active participation in team meetings, interaction with team members, sharing information, and proactive problem identification and resolution.

Provide routine updates and moderately complex reports to trial supervisor(s) and other assigned contacts to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities with minimal to no guidance.
a. Communicate with teammates to consolidate accurate and complete assessments of sites' activities. Routinely report updates to trial supervisor without prompting.
b. Routinely communicate with internal partners as needed for trial activities.
c. Independently assess findings and recommend resolution of complex issues.



Requisition Number
401030863

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1449 CLINICAL RESEARCH ASSOCIATE II

Job Family Level
80

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications

Education
Work requires graduation from. an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience; or one of the following equivalents:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or

2.Completion of a master's degree in Public Health,., Health Administration or a related area with. one year directly related clinical trials research experience; or

3. Completion of a bachelor's degree plus a Minimum of two years directly related experience in clinical trials research; or

4. Completion of a bachelor's degree plus a minimum of three years closely related research experience.

**State of North Carolina license may be required.**
Experience
None :required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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.


Auto req ID

73616BR

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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