REGIONAL SENIOR CLINICAL RESEARCH ASSOCIATE - SOUTHWEST
Location: Field, Kentucky
Description: AbbVie is currently interviewing REGIONAL SENIOR CLINICAL RESEARCH ASSOCIATE - SOUTHWEST right now, this job will be ordered in Kentucky. Further informations about this job opportunity kindly see the descriptions. -
13000001T9
Description
AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 foll! owing separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
PRIMARY JOB FUNCTION:
Manage activities of clinical investigative sites (Southwest - FL, GA, SC, AL, MS, LA, AK) as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an independent and regionally based capacity.
The Regional Senior Clinical Research Associate (RS-CRA) will be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational! issues). Additionally, the RS-CRA may train and provide guida! nce to junior staff.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes.
- Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
- Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues.
- Manage the overall activities of site personnel over whom ther! e is no direct authority and motivate/influence them to meet study objectives.
- Ensure quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensure safety and protection of study subjects according to the monitoring plan, AbbVie SOPs, ICH Guidelines, and federal regulations.
- Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Appropriately escalate serious or outstanding issues to Regional Manager (RM) or the appropriate project team member(s).
- Facilitate Quality Assurance Audit processes as indicated.
- Ensure regulatory inspection readiness at assigned clinical sites.
- Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, i! n a timely, concise and objective manner.
- Participate in field! training and mentoring of new/junior CRAs. May provide input relative to performance review and development opportunities.
- Identify, evaluate and recommend new/potential investigators/sites on an on-going basis. Partners with CO personnel in the identification of qualified investigators.
- Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator, pharmacist), peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with AbbVie personnel.
- Build relationships with current and potential investigators. Provide training and develop investigators/sites that are new to clinical research. Establish expectations for the conduct of AbbVie sponsored clinical trials.
- Proactively identify issues that may impact enrollment and recruitment timelines. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines! are met.
- Participate in departmental meetings.
- Employ good fiscal management to conserve costs of departmental operation and controls travel expenses, with guidance from the RM.
- Identify and partner with other AbbVie personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of CFO and conserve overall departmental operating costs.
- Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.
- Participate in and or present at departmental or investigator meetings.
- Participate in special projects/work groups.
- Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
POSITION ACCOUNTABILITY / SCOPE:
The ! RS-CRA is accountable to the RM. The RS-CRA conducts clinical site moni! toring visits across multiple protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. They manage sites of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
The RS-CRA ensures regulatory inspection readiness at assigned clinical sites.
Qualifications
Bachelor’s Degree required; medical/science/nursing background is preferred
MS, MA, MBA, MPH desired
Experience
- Minimum of 5 years of clinical related experience, of which at least 3 years must be in clinical research monitoring
- Strong site management and monitoring skills
- Experience in multi-therapeutic areas desired
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they! relate to the conduct of clinical trials
- Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations
- Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Excellent verbal and written communication skills
- Acute observational skills, analytical and conceptual capabilities
- Exhibit high level of flexibility when facing changes in the work environment
- Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications
- Working knowledge and experience with electronic data capture systems and clinical trials management systems
- Strong ability to work independently in a geographic region with minimal supervision The RS-CRA anticipates and proactively solves study-related clinical ! site issues as they occur and initiates, recommends and communicates corrective action as indicated. They use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action taken at the clinical site is properly documented.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Job Classification
:
Experienced
Job
:
CLINICAL RESEARCH
Primary Location
:
USA-Field
Organization
:
GPRD-Pharma R&D
Schedule
:
Full-time
Shift
:
Day
Travel
:
Yes, 75 % of the Time
- .
If you were eligible to this job, please email us your resume, with salary requirements and a resume to AbbVie.
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This job starts available on: Thu, 09 May 2013 10:58:58 GMT
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