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Senior In-House Clinical Research Associate

Job Attributes

Job Id:

30783

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Clinical Solutions is currently seeking a motivated Senior In-House Clinical Research Associate to support an established biopharmaceutical company in Rockville, MD. The Senior In-House Clinical Research Associate will play a key role in all aspects of a multi-national oncology based clinical research trial.

 

Responsibilities for the Senior In-House Clinical Research Associate:


·       Responsible for all clinical trial monitoring activities including vendor & Clinical Research Organization (CRO) management, documentation collection, site training & communication, protocol & regulatory adherence, site clinical supplies coordination, and systems database management on a global scale

·       Oversight and management of CRO’s, Central Laboratory operations, and vendors including site queries, education, and site documentation and data collection

·       Collaborate with CRO, Principal Investigator, and Project Managers to plan, implement and oversee clinical trial activities

·       Develop detailed understanding of study specific protocols and SOP’s to ensure all study sites adhere to Good Clinical Practices (GCP)/ ICH guidelines and IRB/FDA regulations

·       Train and educate trial site personnel on study protocols, SOP’s and government regulations to ensure adherence to GCP, IRB, FDA and other regulations

·       Review and process incoming study documents including Case Report Forms (CRF), Informed Consent Forms (ICF) and SRP packages to ensure adherence to applicable trial regulations and protocols

·       Develop, Manage & Update study systems and databases including Electronic Document Capture (EDC), Central Labs System, Clinical Trial Management System (CTMS), and Electronic Trial Master File (eTMF)

·       Participate in study phase transitions including data locks, close outs and start-up operations and procedures

·       Collaborate with internal personnel & leaders to identify, develop, and implement operational improvement, Strategic Research Plans (SRP), Risk Areas and Corrective and Preventative Action Plans (CAPA)

·       Minimal travel requirements – the In-House CRA will be expected to be on-site 3 days a week and 2 days remotely

Requirements for the Senior In-House Clinical Research Associate:

·       3+ years of commercial pharmaceutical CRA experience (at least 1 year as In-House CRA)

·       2+ years of multi-phase (Phase II-IV) oncology specific clinical trials experience

·       Experience with direct Vendor, CRO, & Central Lab Management, Trial Systems and Database Operations (eTMF, EDC, CTMS, EMR/EHR)

Compensation for the Senior In-House Clinical Research Associate:

·       Salary between $80,000 – $110,000 based on meeting of minimum requirements

·       Benefits: Health, Dental & Vision Insurance, 401k Contributions ETC


 

Keywords:

Clinical research associate, CRA, in-house CRA, pharmaceutical, pharma, biotechnology, clinical research, regulatory affairs, regulatory affairs specialist, regulatory associate, FDA, GCP, clinical trials, phase I, phase II, oncology trials, oncology clinical research, site management, vendor management, clinical research organization, CRO, standard operating procedure, SOP, trial master file, TMF, compliance, guidelines, clinical trial site, IRB, bioclinica, rave, CAPA, corrective and preventive action, ETMF, Electronic Trial Master File, Case Report Forms, CRF, Informed Consent Forms, ICF, srp, strategic research plan, Electronic Document Capture, EDC, Central Labs System, Clinical Trial Management System, CTMS, senior Clinical research associate

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New Search

Job Id:

30783

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions