CLINICAL TRIALS COORDINATOR II, DCRI

School of Medicine

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Clinical Trials Coordinator II - Government Operations

Position Summary:

The Government Trials & Network Trial Coordinator (CTC) is responsible for performing and implementing a variety of independent duties involved in the organization, training, oversight, documentation, conduct and clinical data review for clinical trials that are being managed by Duke Clinical Research Institute (DCRI). This work is done for phase I, II, III, IV, trials and other clinical research endeavors conducted by DCRI.

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut

Primary Responsibilities and Tasks

Project/Trial Organization

* Draft/Create Project-Specific Plans/Documents for trial activities:

• Feasibility Form
• CTMS Setup Form
• Data Entry Guidelines (DEGs)
• Manual of Operations (MOO/MOP)
• In-service Manual
• Regulatory document collection process
• Custom Reports

* Compile site feasibility information and provide site feedback to trial supervisor

* Provide content to Clinical Monitoring Plan (CMP).

Project/Trial Training

* Participate in delivering trainings for Project-Specific Plans/Documents by utilizing a variety of applications (Word, Excel, PowerPoint)

* Participate in trial training and guidance to research staff (internal and external) for conducting the study in accordance with the following:

• Protocol
• SOPs
• Trial specific procedures
• Applicable regulations

Site Management Oversight

• Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams.
• Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues
• Routinely review available metrics reports, data entry and inspect study files to ensure completeness and accuracy. Take action as appropriate by providing feedback/training if required
• Oversee distribution of appropriate forms, supplies, equipment, laboratory samples, and investigational product are received by the site according to the established trial timeline
• Communicate with laboratories or investigators regarding laboratory findings
• Direct the process for collection, labeling, storage, or shipment of specimens
• Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies

Project/Trial Documentation

* Serve as Clinical Trial Management System (CTMS) user by being able to perform, explain and train on the following activities:

* DEG

* Clinical Trial Management System Request Form (CTMSR)

* Site Creation

* Global Data Requests

* Site Status

* Activity Plans

* Milestone Tracking

* Document attachment (Training/Safety Letters/other)

* Account Affiliations

* Conversation Log

* Available reports

* Confirmation/Follow-Up Letters

• Complete CTMS data entry and Trial Master File (TMF) filing in compliance with DEG and Standard Operating Procedures (SOPs)
• Independently review of the following regulatory documents for assigned Trials:

* Protocol Signature Page

* Form FDA 1572

* Principal Investigator Curriculum Vitae (CV) and Medical License

* Principal Investigator Financial Disclosure

* Sub-investigator Curriculum Vitae (CV) and Medical License

* Sub-investigator(s) Financial Disclosure(s)

* IRB Approval of Protocol and any Amendment(s)

* IRB Approval of Informed Consent Form

* IRB Approval of Assent Form

* IRB Approval of Translation of ICF & Assent Form

• IRB Approval of Health Insurance Portability and Accountability Act (HIPAA) Investigator's Brochure (IB) IRB Membership Roster or FWA number

Clinical Trial Conduct

* Interpret protocols and advise internal staff on appropriate conduct of the study in accordance with the protocol, SOPs, trial supervisor, trial specific procedures and applicable regulations

* Identify protocol problems, inform trial supervisor of problems, or assist in problem resolution efforts such as protocol revisions

* Independently monitor all assigned trial activities/communications to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

* Identify action items and discuss with appropriate research staff. Communicate routine and unusual findings to trial supervisor

Regularly review trial and site status information and enter updates into required systems to maintain accurate, current reports.

• Follow established guidelines in the collection of clinical data and/or administration of clinical trials

* Confer with site coordinators to explain protocol and elicit compliance with regulations; ensure compliance with Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.

• Perform activities of monitoring staff on a temporary basis as needed to move project deliverables and timelines forward.
• Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
• Confer and work with trial supervisor to provide recommendations, and offer guidance to others regarding issues/questions that were unable to be resolved at lower level. Provide system expertise to support project teams and functional groups regarding proper use of systems/project processes in compliance with regulations/policies.

Clinical Data Review

• Perform in-house monitoring activities by independently reviewing and evaluating the following:

• Informed Consent Forms (ICFs)
• Source documentation
• Case Report Forms (CRFs)
• Adverse Events (AEs)
• Serious Adverse Events (SAEs)
• Laboratory results

• Uses knowledge of protocol to interpret data and work with trial supervisor and other functional groups to resolve clinical data issues

• Routinely use data management reports/system to identify/resolve discrepancies in the clinical data

• Participate in the design/review of new processes/guidelines related to data processing and integrity.

Accountability

• Identifies and follows through on opportunities for self-improvement.

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN). Physician's Assistant (PA) or Pharmacists plus a minimum of two years 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 a minimum of one year directly related clinical trials research experience; or

3. Completion of a Bachelor's degree plus a minimum of two years directly related 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 licensure may be required**

None required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Work requires graduation from an accredited degree program providing 1. Completion of an allied health degree (e.g., Respiratory Therapy, clinical training as a Registered Nurse (RN). Physician's Assistant (PA) or Pharmacists plus a minimum of two years healthcare experience, or one of the followingequivalents: 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 a minimum of one year directly related clinical trials research experience; or 3. Completion of a Bachelor's degree plus a minimum of two years directly related clinical trials research; or 4. Completion of a Bachelor's degreeplus a minimum of three years closely related research experience. **State of North Carolina licensure may be required**

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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.

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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.