CLINICAL TRIALS ASSISTANT II
CLINICAL TRIALS ASSISTANT II
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.
Provide site management, monitoring, and regulatory administrative and technical support to the clinical operations trial team for assigned clinical trials as directed by trial supervisor in accordance with departmental and project-specific guidelines, SOPs, applicable regulations and ICH guidelines.
Manage information with some guidance for site,project, and team activities in established systems and spreadsheets 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 directed.
Assist with development, compilation, dissemination, collection, tracking and report generation of regulatory and other essential trial documents with some guidance.
a. Develop and edit 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.
c. Perform initial review of in-coming documents for completeness, accuracy and consistency with established guidelines.
d. Maintain accurate and complete regulatory and investigator files according to SOPs and established trial-specific guidelines.
e. Distribute safety reports to sites and track as directed.
f. Generate and distribute standard study reports.
g. Assist with preparation of study files for audits.
h. Maintain security of electronic and paper study documents throughout all work activities.
Support clinical operations 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 with some guidance.
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.
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 as directed.
d. Assist with routine review and upkeep of site and project files to maintain complete and current versions of all essential documents.
e. Assist with completion, submission and tracking of 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 integration of new team members.
k. Assist with development and implementation of project-specific forms and work instructions as directed.
Assist with the collection and tracking of completed data forms, data queries and source documents as directed.
a. Send queries to sites as directed, assist with routine 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. Follow up with site personnel to collect outstanding data and provide site education and reinforcement as directed.
c. Assist with requests, collection, and tracking of source documents for assigned sites.
Provide administrative assistance for designated project meetings as directed by trial supervisor.
a. Assist with meeting preparations, generation and distribution of minutes, and filing specified information for designated project meetings.
b. Assist in compiling and assembling packets for investigator meetings, study-related meetings and national conventions.
c. Attend and support regular trial team meetings and other internal meetings as directed.
d. Assist with 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.
Assist with routine site communication. 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 routine 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. Assist with developing, disseminating, and filing 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.
Other Duties: Assist with other clinical trial activities as directed. Work with other departments and external partners. Assist with investigator meeting preparation including mailing invitations, tracking responses and travel arrangements and assembly of meeting materials. May rarely travel to attend meeting to assist with clerical and administrative support as directed. Assist with final review and archival of trial files. Maintain job knowledge and skills through independent self study. Actively support the DCRI and the clinical operations department. Review education and training experience with line manager and complete identified training needs within designated time period. Complete administrative activities accurately and in a timely manner, e.g., time tracking, time cards, training file. Attend department meetings. Assist with training of new personnel as directed. Practice cost-saving methods. Participate in 360 feedback activities for self and others for annual performance evaluations.
52 CLINICAL TRIALS ASSISTANT II
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an AA/AS degree.
Work requires two years directly related experience in clinical trials research; or three years general research experience. Perform a variety of research, data base and clerical duties in support of multi-center clinical trials. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
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.