ASSIST RESEARCH PRACTICE MANAGER


diversity employer



ASSIST RESEARCH PRACTICE MANAGER
DCRI Duke Clinical Research Unit

Occupational Summary

Responsible to the CRU Research Practice Manager for the day-to-day operations of the CRU or delegated CRU responsibilities associated with the Clinical Research Unit's participation in clinical research studies as an investigative site. Ensure that CRCs and designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke Policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring. Work Performed Serves as assistant to RPM and includes divisional or cluster lead within a CRU with oversight of peers and delegation of project related tasks to others in leadership roles in cluster. Is knowledgeable of various funding sources including industry or federal grants. Ensure that staff is appropriately trained.

Participate in assessing the feasibility of new studies within DEPRU and cluster. Ensure that new studies are initiated appropriately and monitor the performance and progress of ongoing studies. Review new IRB submissions forappropriate staffing, completeness of submission, and return to research team for correction if needed. Assign new protocols to scientific, financial and CRU reviewers. Review Research Data Security Plans for new IRB submissions (paper section only) and assign to appropriate IT reviewer. Ensure appropriate coordination of IRB submissions, participant recruitment, (timely entry of consented subjects into Maestro Care), screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention. Supervise the day-to-day operations of the CRU related to study conduct including IRB submissions and renewals (monitor timely submission of renewals and progress to approval) review and ensure accurate key personnel list on IRB submissions and renewals) ; protocol initiation; patient recruitment, screening, consent, enrollmentand follow-up; data collection; safety reporting; drug accountability; study close-out and record retention.

Review and supervise activities performed by study coordinators and other research staff involved in study conduct and ensure that activities are performed in accordance with Good Clinical Practice standards, Duke Policies and procedures, and applicable regulatory requirements. Assist the RPM with scheduling of regular meetings with study coordinators and other research staff and attend regular meetings. Ensure that staff is kept abreast of CRU, departmental and institutional activities, goals, and policies and procedures through assisting RPM with daily oversight of CRU research staff, clinical research coordinators and clinical trial assistants.

Plan and coordinate orientation and ongoing training for study coordinators and other research staff for DEPRU. Ensure that current training records and required certifications are maintained for DEPRU CRU, cluster and others as needed. APRM may assist in supervision of the staff on an ongoing status. APRM will also provide back up to RPM as needed. Ensure appropriate planning and coordination prior to the approval and initiation of new protocols; including the accurate and timely submission of appropriate paperwork to all required departments for grillander/Maestro Care build.

Also ensuring that appropriate paperwork is forwarded to other Duke departments where procedures are required and doing so in a timely manner. Keeping up with very tight timelines from sponsors and reaching out to departments where information is still pending to ensure timelines are met. Monitor the status of start-up timelines for new studies including IRB approval and contract execution. Monitor the progress of ongoing studies including enrollment, data collection, renewal, and close-out. Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.

Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions. Participate in audits conducted by internal groups, sponsors, and regulatory authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems in research practice are identified. Conduct CRU QA audits for division or cluster. Ensure that the CRU has up-to-date standard operating procedures, that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs. REPORTING RELATIONSHIP The Assistant Research Practice Manager will report to the Research Practice Manager. Preference to those with experience in healthy volunteer phase 1 clinical trials.

Requisition Number
401309174

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1045 ASSIST RESEARCH PRACTICE MANAGER

Job Family Level
68

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
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.

Education

Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.

Experience

No experience is required beyond what is specified above.

Auto req ID

92796BR

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.

PI99112487