- 02-Apr-2014 to 30-Jun-2014 (PST)
- Clinical Research
- Sunnyvale, CA, USA
- Full Time
Regional Clinical Research Consultant
The Clinical Research Consultant is responsible for tasks that relate to the monitoring and management of clinical trials. Regionally based consultants work out of their home office providing monitoring of Phase 1-4 clinical trials, assuring adherence to Good Clinical Practice. This position may consistently involve up to 65% travel. Regionally based Clinical Research Consultants may be involved in some or all of the tasks listed below:
• Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out.
• Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
• Monitoring and documenting investigational product dispensing, inventory, and reconciliation.
• Monitoring and documenting laboratory sample storage and shipment.
• Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities.
• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
• Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
• Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues.
• Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present.
• Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
• Staff residing in the San Francisco Bay Area may be required to commute to the ProTrials Headquarters office or a client's office, as required by assigned projects
• Other tasks or responsibilities as assigned.
The Employee shall work well under pressure, and meet multiple and sometimes competing deadlines. The Employee shall at all times demonstrate cooperative behavior with colleagues and supervisors.
• Attention to detail
• Flexibility with changing priorities
• Functional familiarity with medical and pharmaceutical industry terminology and practices.
• Excellent organizational skills
• Ability to efficiently perform and prioritize multiple tasks
• Ability to identify and take initiative to solve logistical problems
• Ability to maintain travel schedules efficiently and effectively
• Effective verbal and written communication skills
• Ability to work effectively both independently and on a diverse team
• General computer skills (PC based) with proficiency in Microsoft Word and Excel
• Ability to work efficiently on the computer, including document retrieval, review, and tracking, that may include but not be limited to:
• Typing for 6 or more hours per day
• Turning pages repetitively during document review
• Opening file drawers and inserting or removing multiple files up to 4" thick
• Ability to move heavy documents and binders
• May require lifting of items greater than 15 lbs.
• May require placing items of 10 lbs. or more in overhead shelves
• Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
• The Clinical Research Consultant reports to a designated Line Manager regarding general skills and career development.
• The Clinical Research Consultant may also report to one of the following depending on the needs of the current assignment: lead CRA, client contact, Clinical Project Manager, ProTrials Management.
• The Clinical Research Consultant (Regionally Based) works from their home office, and travels to study site and meeting locations.
Hours and time recording
• The Clinical Research Consultant is expected to manage her/his time in a professional manner and to generally work a 40-hour week unless another schedule has been agreed on with ProTrials Management and the client in writing.
• Time worked is expected to be flexible, based on travel and site-appointment requirements. Although the assignment is expected to be completed within the agreed-upon work week, weekly or daily time required for the position will vary, depending on business needs and expectations.
• This is an exempt position. As an exempt employee, the Clinical Research Consultant will not be paid overtime even if required to work more than eight hours in a day or forty hours in a week.
• Time worked and tasks performed will be recorded by the employee.
Qualifications – Minimum Required
• Nursing registration or licensure and/or 4-year degree, preferably in a scientific or health care discipline, or equivalent combination of education, clinical research certification, and/or experience.
• At least 3 years of prior experience as a Clinical Research Associate, including monitoring experience. More experience may be required for specific assignments.
• Must have availability of a car in good condition, a valid driver's license, a good driving record, and car insurance.
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