Overview
Responsible for assisting with clinical trial management and site management. Serves as support staff in activities such as protocol and informed consent preparation/finalization, reviewing of CRF and CRF guidelines, participating in ongoing clinical data review, study plans/presentations development, investigative site selection/credentialing, site contract/budget negotiations, regulatory/review board submissions/approvals and site training/initiation.
Essential Functions and Responsibilities
- Supports the set-up and on-time execution of clinical tasks, while ensuring the trial is conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements
- Supports Clinical Trial Manager/Clinical Director in scheduling of internal and external team meetings, investigator meetings, and other trial specific meetings as required
- Attends and serves as scribe for internal and external team meetings, supporting agendas, minutes and action item tracking
- Effectively tracks, files and archives study communications, contracts, essential documents, to provide a complete TMF and Sponsor records
- Collates and maintains study metrics for reporting purposes through established clinical study dashboards and trackers; with archiving of reports
- Supports risk management and mitigation through competing tasks and highlighting issues to ensure study objectives are successfully accomplished
- Responsible for the distribution and archiving of study newsletters, tracking and reporting of recruitment updates
- Assists with supporting oversight of vendors/CROs, including invoice processing
- Reviews monitoring trip reports and follow-up of action items to resolution
- May participate in site visits as needed or accompany Sponsor/CRO members for training and support purposes
- Maintains completion of required corporate training on standards, policies, work instructions by due date
- Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
- Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Associate’s Degree or equivalent with minimum 3 to 5 years of clinical research experience
- Demonstrated experience in core and technical aspects of supporting phase 1-3 clinical trials
- Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
- Excellent interpersonal and communication skills
- Success working in a fast-pace matrix environment
- In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT,
- Proactive, self-directed, able to thrive and adapt in a rapidly changing environment
- Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/when needed
- Successful management of clinical studies within timeline and budget
- Able to set a high level of accountability and quality in deliverables
- Able to build strong relationships with peers and partners both within and across functional teams to engage high performance
- Strives to create a dynamic environment, opens to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages goals to reality
Preferred Education, Skills, and Knowledge
- Bachelor’s Degree preferred
- Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm and Safety/ Pharmacovigilance databases (ARGUS) a plus
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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