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Clinical Trial Assistant

New Jersey All, NJ

Posted: 10/17/2019 Job Type: Clinical Job Number: JN -102019-25832

Job Description

The Clinical Trial Assistant will support Clinical Science Operations (CSO) team in the planning, execution and reporting of US Oncology/Hematology Medical Affairs Trials.

Responsible for supporting the CSO team in the implementation of designated clinical trials/IITs/MAPs including but not limited to investigator selection, patient recruitment, preparation of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements), and organizing Ethics committee submissions

Support CSO team in tracking and managing key trial indicators including: monthly project status, key deliverables to management

Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems

Supports U.S. Trial lead(s) for non-registration U.S. Medical Affairs Trials (including phase I-IV, MAPs, Investigator Initiated trials)

Supports interface with the oncology and U.S. clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas

Updating appropriate databases(contact information), CTMS system, tracking, sending out info to sites, e-mailing sites, payments, right hand person to Trial Lead, takes minutes, sets up meetings, reg doc collections (familiar with 1572s, IRB documents, trial master files content)

Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions

Support Trial Leads in liaising with study investigators, site research staff, and field based colleagues to support clinical studies

Organize investigator s start-up meeting and study site initiation meetings

Support study enrollment efforts, planning for investigator meetings

Assist CSO in the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency as appropriate

Support the trial leads in the development, management and tracking of trial budgets working closely with the appropriate external partners

Requirements:

Bachelor s Degree with 1 to 2 years of CTA experience from a pharmaceutical, biotech or CRO company

Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

Strong customer focus, excellent interpersonal skills and strong attention to detail

Effective organizational and time management skills

Proven flexibility and adaptability

Excellent team player with team building skills

Ability to work independently as required

Ability to utilize problem-solving techniques applicable to constantly changing environment

Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software

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