Clinical Trial Associate / Inhouse CRA – BioPharma- (Phase II) – RTP, NC – Local Candidates Only
Our client, an RTP area biopharmaceutical company, is actively recruiting for a detail-oriented Clinical Trial Associate / Inhouse CRA to provide project support to the Clinical Management team and clinical staff.
This is an emerging company in which everyone pitches in and responsibilities are broad. Seek candidate who thrives in a hub role. This CTA / Inhouse CRA will support clinical programs ensuring that clinical trial activities are conducted in accordance with company SOPs, Good Clinical Practice, ICH Guidelines and regulatory requirements.
Responsibilities will include trial document and systems management support from trial startup, maintenance and closeout. The CTA / Inhouse CRA will assist clinical teams with vendor oversight activities, data review, biosample reconciliation, tracking/ordering of investigational drug product and tracking of investigator payments. The CTA / Inhouse CRA will also be involved in remote monitoring activities.
The near-term focus will be Phase II studies.
Specific duties will include:
- Assist clinical management in clinical study operational planning, to include IRB/EC application preparation and submission, vendor oversight, study timelines and recruitment plans
- Assist in the collection, review and approval of country specific, site-specific, and essential regulatory documents, to include study document upload, QC and maintenance of all in-house trial files, site files and trial master files
- Develop and maintain documents, tracking tools, forms and related items, to include reformatting and troubleshooting issues with existing documents and macros
- Assist with regular data review and data cleaning
- Assist with remote monitoring activities
- Perform biosample tracking, reconciliation and query resolution, as well as managing shipments to affiliate labs
- Maintain inventory of investigational drug product at drug depots and sites, to include ordering based on site need
- Assist Clinical Management and clinical staff with site budgets and payment schedule, to include providing budgetary information, enrollment and other clinical updates
- Tracking and updating clinical leadership of sites and study status.
Targeted candidate will offer a related degree (BS expected) and 2+ years of clinical support experience in pharma or biotech with heavy emphasis on document tracking and control. Experience with remote monitoring would be valuable, as well as experience with respiratory infectious disease or immunology.
In addition, we seek an independent, knowledgeable and flexible professional who will work exceedingly well in a dynamic and collaborative setting; One who can adapt to changing priorities and one who has the ability to take initiative to complete tasks under tight deadlines.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.