CLINICAL TRIALS SPECIALIST, DCRI Mega Trials - Military Veterans

at Duke University and Duke University Health System

Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Position Summary:

Provide site management, monitoring, and regulatory support to the clinical lead and clinical operations team for assigned clinical trials, with minimal to no guidance, in accordance with departmental and project-specific guidelines, SOPs, applicable regulations and ICH guidelines. Function as regulatory document and investigator database specialist in support of clinical trial activities with minimal to no guidance.

 


Position Responsibilities & Key Tasks:
Manage information for site, project, and team activities in systems and spreadsheets independently according to applicable SOPs, guidelines, and study specific-requirements.
a. Track dissemination, receipt and approval status of study-related documents. Maintain investigator database with all required information for assigned clinical trial sites.
b. Collect and track required site information and documents prior to shipment of regulatory packet and study materials.
c. Maintain required paper and electronic documents for investigator and regulatory files according to SOPs and study-specific requirements.
d. Prepare and disseminate status reports on regulatory documents, patient enrollment, and data activities for assigned sites.
e. Notify designated contacts for site activation and shipment of study supplies as directed.  Provide follow up as necessary.
f. Recommend and implement improvements for processes and documents as related to site management and clinical monitoring activities.
g. Assist project lead, clinical lead or senior CRA with development of project-specific systems and spreadsheets.

 

Assist the clinical lead, project lead, or senior CRA with development of the regulatory processes, and compilation, dissemination, collection, tracking and report generation of regulatory and other essential trial documents with minimal guidance.
a. Develop and revise spreadsheets and tools as directed.
b. Receive and collect required documents prior to shipment of regulatory packets. Prepare, send, and track out-going regulatory packets. Promptly collect and accurately track all versions of in-coming documents and communications. Proactively contact sites about outstanding, incorrect, or incomplete documents.
c. Review and record findings for in-coming regulatory documents for completeness, accuracy and consistency with established guidelines. Promptly submit reviewed documents for final approval.
d. Independently maintain accurate and complete regulatory and investigator files according to SOPs and established trial-specific guidelines.
e. Distribute and track safety reports to sites.
f. Generate and distribute standard and complex study reports.
g. Assist with development of a process to review study files for audits. Prepare study files for audits as directed.
h. Maintain security of electronic and paper study documents throughout all work activities.
i. Serve as the primary contact for assigned sites for regulatory status, including IRB submission, approval, and renewals.
j. Draft internal work flow processes for regulatory document review and approval.

 

Support clinical operations trial team members through communication with sites, collection and entry of current site status into systems prior to site visits and meetings, regular updates to teammates and trial supervisors, and other project activities as directed. 
a. Assist monitors with preparation and follow-up activities associated with all types of monitoring visits by providing current subject status reports, site status reports, and other related pre- and post-visit support. Call sites for updates as requested.
b. Process study supply request forms from sites, order study supplies, enter study supply requests and shipment data into tracking system and generate reports.
c. Assist with in-house site evaluation, source document collection and close-out activities.
d. Review site and project files for completeness and current versions of all essential documents. Independently collect missing and incomplete documents for assigned sites.
e. Complete, submit and track expense report forms using appropriate financial forms, coding systems, and organizational and trial-specific guidelines.
f. Provide regular updates to trial supervisor and project team without prompting.
g. Provide data entry guidance and training on trial-specific information management systems to other team members.
h. Achieve objectives for independent projects as directed by supervisor.
i. Assist with training of assistants assigned to the trail and the integration of new team members.
j. Assist the clinical lead, project leader, or senior CRA with developing processes and instructions for investigator recruitment, site activation, subject enrollment, data collection and review processes, and site close-out.

 

Assist with development of data collection processes. Collect and track completed data forms, data queries and source documents.
a. Send queries to sites, assist with query resolution, track query receipt and resolution, and file communications and resolutions in trial files.
b. Review data submission status reports to identify late or missing data for assigned sites. Identify trends for sites with consistently late reports or missing data and follow up with site personnel to collect outstanding data, and provide site education and reinforcement to minimize recurrences.
c. Request, collect, and track source documents for assigned sites.

 

Provide administrative assistance for designated project meetings as directed by trial supervisor.
a. Independently prepare for routine meetings. Generate, distribute, and file minutes for designated project meetings.
b. Compile and assemble packets for investigator meetings, study-related meetings and national conventions.
c. Attend and actively participate in regular trial team meetings and other internal meetings as directed.
d. Make travel arrangements and other trip preparations related to various professional activities.
e. Share best practices with peers and make recommendations to trial supervisor for process improvements; implement as directed.

 

Routinely communicate with sites. Communicate and coordinate with other study personnel to support flow of information and trial activities with some guidance.
a. Communicate with sites to assist with study questions in an assertive, business-like manner which fosters cooperation.
b. Assist sites with essential document completion and revision; follow up on missing and incomplete documents.
c. Develop, disseminate, and file enrollment posters and newsletters.
d. Communicate with sites to determine adequacy of study materials and supplies.
e. Communicate with other departments as directed to facilitate trial activities.

 

 

 

 

 

Knowledge, Skills and Abilities

 

 

Strong technical spelling and grammar skills
Strong verbal and written communication skills
Ability to communicate and work productively in a team environment
Strong computer skills in MS including Word, Excel, and investigator data base
Strong organizational skills and attention to detail
Ability to perform multiple activities at once to accomplish individual and team goals
Ability to perform routine clinical trial activities independently
Strong knowledge of regulatory requirements for clinical trial startup, and ongoing processes and systems
Working Knowledge of GCPs

 

 

 

Minimum Qualifications

 

 

 

 

 

 

Education

 

 

1. Completion of a bachelor's degree plus a minimum of one year of experience. directly related experience in clinical trials research; or

2. Completion of a bachelor's degree plus a minimum of two years closely related research experience; or

3. Completion of an associate's degree plus four years experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store

 

 

Experience

 

 

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATIONAND/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.

 

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 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.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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