CLINICAL TRIALS ASSISTANT I, DCRI

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

CLINICAL TRIALS ASSISTANT I, DCRI
DCRI - Site Support & Management


Occupational Summary:

Provide site management, monitoring, and regulatory administrative and technical support to the clinical operations team for assigned clinical trials with guidance as directed by trial supervisor in accordance with departmental and project-specific guidelines, SOPs, applicable regulations and ICH
guidelines.

Primary Responsibilities and Tasks:

1.
Assist with information management for site, project, and team activities in established systems and spreadsheets with guidance according to applicable SOPs, guidelines, and study specific-requirements.

a.
Track dissemination, receipt and approval status of study-related documents as directed. Maintain investigator database with all required information for assigned clinical trial sites with supervision.
b. Collect and track required site information and documents prior to shipment of regulatory packet and study materials with supervision.
c. Maintain required paper and electronic documents for investigator and regulatory files according to SOPs and study-specific requirements with supervision.
d. Prepare and disseminate status reports on regulatory documents, patient enrollment, and data activities for assigned sites as directed.
e. Notify designated contacts for site activation and shipment of study supplies and provide follow up as directed.

2. Support development, compilation, dissemination, collection, tracking and report generation of regulatory and other essential trial documents with guidance.

a.
Develop and edit spreadsheets and tools as directed.
b. Receive and collect required documents prior to shipment of
regulatory packets with supervision. Prepare, send, and track out-going regulatory packets as directed. Promptly collect and accurately track all versions of in-coming documents and communications as directed.
c. Perform initial review of in-coming documents for completeness according to established guidelines.
d. Maintain accurate and complete regulatory and investigator files according to SOPs and established trial-specific guidelines with supervision.
e. Distribute safety reports to sites and track with supervision.
f. Generate and distribute standard study reports as directed.
g. Assist with preparation of study files for audits with supervision.
h. Maintain security of electronic and paper study documents throughout all work activities as directed.

3. Support clinical operations team members through communication with sites, collection and entry of current site status into SM systems prior to site visits and meetings, regular updates to teammates and trial supervisors, and other project activities with 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 as directed.
b. Process study supply request forms from sites, order study supplies, enter study supply requests and shipment data into tracking system and generate reports as directed.
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 with supervision.
e. Assist with completion, submission and tracking of expense report forms using appropriate financial forms, coding systems, and organizational and trial-specific guidelines as directed.
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 as directed.
h. Achieve objectives for independent projects as directed by supervisor.
i. Assist with integration of new team members as directed.
j. Assist with development and implementation of project-specific forms and work instructions as directed.

4. Support 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.

5. 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 as directed.
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 with direction.

6. Assist with routine site communication. Communicate and coordinate with other study personnel to support flow of information and trial activities with guidance.

a.
Communicate with sites as directed 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 with supervision.
c. Assist with developing, disseminating, and filing enrollment posters and newsletters as directed.
d. Communicate with sites to determine adequacy of study materials and supplies as directed.
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, timecards, 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.
Perform other related duties incidental to the work described herein.

Preferred Education: Bachelor's Degree


Requisition Number
401202030

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
56 CLINICAL TRIALS ASSISTANT I

Job Family Level
06

Exempt/Non-Exempt
Non-exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications


Education

Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.

Experience

Work requires one year experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Strong technical spelling and grammar skills Ability to communicate and work productively in a team environment Basic computer skills including MS Word and Excel Good organizational skills Ability to follow detailed instructions Basic knowledge of clinical research is preferred

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 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.

Auto req ID

85526BR

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.

PI97509933