Quality Controls Assistants / Trainees (Male)
Jafferjee Brothers Exports (Pvt) Ltd
Salary $100,443 - $250,685 a year job type full-time
Us work authorization (preferred)
Full job description
Prelude is an early-stage biotechnology company founded by proven scientists in cancer drug developmentOur research is focused on developing highly selective and differentiated small molecule therapeutic agents targeting novel pathways for the treatment of cancer and rare diseases.
Prelude offers a vibrant and collegial work environment and excellent career growth opportunitiesPrelude is ideally located within 25 minutes from the philadelphia international airport at the delaware innovation space, an emerging research campus in the dupont experimental station.
The clinical trial associate (cta) will be responsible for assisting with clinical trial operational activities for various assets within prelude therapeutics’ pipeline while having the ability to multi-task on other company initiatives and activitiesThe individual will assist the clinical trial manager (ctm) with assignedtasks to help ensure operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, sops and business guidelines.
Responsibilities and duties:
· assist the ctm in the day-to-day activities of assigned clinical trials to ensure goals and timelines are met with quality, in compliance of sops and regulatory guidelines.
O for projects outsourced to a clinical research organization (cro), the cta will work with ctm to oversee and monitor cro performance for all contracted services.
O for projects insourced, the cta will work with the ctm to help support the internal team in daily operational activities in line with all applicable regulations and internal processes.
· maintain clinical trial files, tracking systems and other utilized study systems.
· support project oversight.
· generate and distribute status reports to management and other clinical team members.
· assist ctm in collection of relevant study information on timelines, progress and resources.
· assist in the development of clinical trial documents.
· assist the ctm or designee in the clinical trial tracking and management of clinical supplies.
· assist the ctm with trial master file (tmf) oversight.
· provide support in clinical trial team meetings such as working with the ctm to develop meeting agendas and powerpoint slides, taking and distributing meeting minutes, and following up on action items.
· complete assigned tasks in accordance with sops and guidelines, good clinical practice (gcp), international council on harmonisation (ich) guidelines and regulatory requirements for clinical trial management.
· provide progress updates and summaries.
· communicate study-related information to vendors as appropriate.
· assist in the management of cro/vendors to ensure deliverables are met with quality per contracted scope of work and in compliance with ich/gcp and regulatory guidelines.
· assist with vendor confidentiality agreements, contracting and financial reconciliation.
· other tasks may be assigned based on skill sets and business needs.
· some travel will be required (10-20% depending on project needs).
· associates degree or other health related background
· 1-2 years of clinical trial familiarity or 3-5 years health care experience
· ability to manage several ongoing projects, escalate and prioritize.
· excellent communication skills.
· ability to work within a remote team is required.
· excellent computer skills (microsoft office suite (word, excel, powerpoint, outlook) and (be internet adept)) including the ability to adapt to new systems.
· familiarity of ich/gcp.
· as key member of the clinical operations team, this position builds relationships with cross-functional team members.
· exhibits a high level of professionalism, self-motivated, comfortable with shifting priorities and willingness to take direction.
Physical activities: reaching, talking and hearing.
Physical requirements: sedentary work.
Visual acuity requirements: close visual acuity required for activities such as: preparing and analyzing data and figures; viewing a computer terminal; and extensive reading.
Working conditions: noneThe worker is not substantially exposed to adverse environmental conditions (such as in typical office or home office or administrative work).
Prelude therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local lawsThis policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Prelude therapeutics, incDoes not accept unsolicited resumes from recruiters, employment agencies, or staffing firmsTo conduct business with prelude, a master services agreement (msa) must be executed and confirmed prior to submitting any information relating to a potential candidateWithout a signed msa, prelude shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.
And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed msa, prelude has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/o
Job type: full-time
Pay: $100,443.00 - $250,685.00 per year
Employee assistance program
Flexible spending account
Paid time off
Professional development assistance
Monday to friday
Do you have experience simultaneously assisting with the management of multiple outsourced (cro) and internal clinical operations projects from start-up to completion?
Pharmaceutical industry: 7 years (required)
Only full-time employees eligible
Remote interview process
Personal protective equipment provided or required
Plastic shield at work stations
Social distancing guidelines in place
Sanitizing, disinfecting, or cleaning procedures in place