||Clinical Trial Associate
||March 7, 2020
||Full time Employee
|MANAGERIALLY RESPONSIBLE FOR:
ESSENTIAL JOB FUNCTIONS:
- This role is a support function to the Clinical Project Managers. It is primarily administrative in nature with key tasks contributing to operational excellence in trial execution.
- Responsible for assisting the CPMs with the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.
- Collaborate with internal and external team members
- Assist with oversight of operational activities from start-up to close-out to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
- Assist study team to ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan.
- Assist with the development and review of study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, laboratory and pharmacy manuals, data management plans, etc.
- Collaborate with legal (and others, as needed) on the management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.)
- Assist with organizing and managing project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly; support management of POs and invoices
- Assist study team in the conduct of studies and ensure they are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
- Responsible for collecting, tracking and reviewing investigator site regulatory documents for completion and accuracy, including FDFs, 1572’s, CVs, medical licenses and other study specific documents as needed.
- Responsible for reconciling site regulatory documents with the Trial Master File (TMF).
- Responsible for tracking regulatory and other essential study documents, CTA/budget status, site and vendor payments, SUSARs (safety letter) and monitoring visits/reports.
- Assist with the review and approval of study site and vendor payments.
- Responsible for recording minutes for vendor, study team and site teleconferences, distributing for team review and consolidating comments into one document prior to submitting for finalization and distribution to the study team.
- Assist study team in managing study start-up, conduct and close-out activities and other project related activities.
- Assist with oversight of CRO management of the TMF to ensure study related documents at the site and trial level are inspection ready at all times.
- Assist with ordering and tracking delivery and receipt of required study supplies and investigational product to study sites and provide regular status updates.
- Assist with tracking enrollment status and providing updates to study team and vendors.
- Assist with oversight and tracking receipt of laboratory samples to the laboratory vendor(s)
- Complete other duties as assigned by the manager.
- Candidates should have B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education. Associate degrees considered, depending on experience.
- At least 3 years of clinical research/trial experience or relevant work in the pharmaceutical/biopharma industry. Some experience in oncology preferred.
- Experience in CRO oversight is preferred.
- Highly proficient in software applications such as Word, Excel and PowerPoint.
- Strong organization, documentation and communication skills with an ability to multitask.
- Excellent interpersonal skills; ability to collaborate across disciplines.
While performing the duties the employee is:
- constantly required to sit, and to reach to use computers and other office equipment
- occasionally stand for extended periods of time, up to four (4) hours/time.
- occasionally required to lift up to 10 pounds
- constantly required to view objects at close and distant ranges
- frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in a professional office environment and lab with lots of computer equipment, tools, and moderate amounts of noise and activity. Employee may occasionally be required to travel. The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.
Kura Oncology is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package. To apply, please submit your resume to firstname.lastname@example.org