Contract - Clinical Research Associate

International Full Service CRO Seeking Experienced

Home Based CRA for Immediate Contract 

 

Job Title:    Contract, Home Based Clinical Research Associate 

Location:  Southern Texas

Therapeutic Area:  Oncology, Vaccines, Cardiology

Travel: All sites within Texas, with one week per month at dedicated location.

 

Job Summary:

 

Designs, plans and implements the overall direction of clinical research projects.  Evaluates and analyzes clinical data.  Must have knowledge in reference to GCP regulations and SOPs.  Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.  Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.  May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms.  Conducts clinical monitoring of field sites to supervise and coordinate clinical studies.  May write protocols.  Preferred candidate will be contentious, flexible, motivated, and eager to work within a fast paced, intense environment.

 

 

Essential Job Responsibilities:

 Coordinates the process of writing, revising and tracking protocols and amendments. Coordinates the development, revision and tracking of all study documents including informed consent and privacy authorization templates, case report forms and completion guidelines, study specific instructions, clinical trial database contents and tracking reports. Delegates tasks as applicable. Ensures clinical trial database contents are complete, accurate and current. Evaluates and recommends the selection of investigators and study sites. Coordinates and participates in investigator meetings. Track and report progress of clinical studies. Monitor, track and manage all study related tasks ensuring compliance with GCP, ICH, applicable regulations and company SOPs. Provide leadership, guidance and training to study team members, co-monitor for consistency and as needed to meet project timelines. Conduct site pre-study, initiation, routine monitoring and study closeout visits. Manage compliance to applicable standards by review of documents, tracking reports and study files and provide feedback and training as necessary. Track and manage the study calendar and provide progress updates to clinical trial management to ensure that timelines are met. Primary contact for all study team members. Conduct team meetings and document meeting minutes. Review the contracts and budgets for study sites and vendors, also approve vendor invoices. Assist with the creation of data edit specifications. Review and provide edits to clinical guidelines, templates and SOPs, as applicable. Assist in the review of study reports. Assist in authoring company/department SOPs, guidelines and templates. May provide work directions to lower level personnel.

 

 

 

 

 

Qualifications/Experience:

 

Bachelor’s degree (BA, BS or BSN) from a four-year college or university in a scientific discipline.  Minimum of 2 years monitoring experience and/or training or equivalent combination of education and experience. Minimum 1 year home based experience. Nursing or health care related experience preferred. Knowledge of GCP/FDA/ICH regulations required.