In-House Clinical Research Associate - CNS (Virtual role may be located anywhere in the Western United States)
Location: Morrisville, North Carolina, United States
Requisition Number: 1641
Position Title: In-house Clinical Research Associate II
We are seeking an experienced In-house CRA responsible for site identification/feasibility, remote EDC monitoring, site management and some study close-out tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Assist with mentoring and training of in-house team members. Provide support to LCRA as applicable and appropriate.
Tasks may include but are not limited to:
- Perform feasibility studies/site identification activities for potential sites, as requested
- Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
- Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification etc.)
- Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
- Assure maintenance of the Investigator Site File in the TMF
- Conduct pre-study, study initiation, interim monitoring visits under the guidance of the local CRA or LCRA/PM, as applicable and appropriate
- Document site visit findings at site visits via written reports, under the guidance of the local CRA or LCRA/PM, as applicable and appropriate
- Maintain regular communication with sites
- Complete remote CRF review, using electronic data capture systems
- Assist sites in query resolution
- Assist with ensuring site compliance with IP receipt, accountability and return or destruction, as applicable and appropriate
- Provide mentoring and training for In-house CRA1 and CRA1
- Assist LCRA with reports and trackers
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
- Requires a bachelor degree or a two-year nursing degree
- Minimum of two years of clinical in-house or regional CRA experience
- Experience in CNS highly desired
- High level of proficiency in both spoken and written English
Employment Type: Regular
Community / Marketing Title: In-House Clinical Research Associate - CNS (Virtual role may be located anywhere in the Western United States)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Bevery Hills, California US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.