Position Information

  • Company: Abbott
  • Division:  Biotechnology/Pharmaceuticals
  • Job Category:  Biotech/R&D/Science
  • Location:  Cleveland, OH
  • Job Status/Type:  Full Time
  • Reference Code:70017BR

SR. REGIONAL CLINICAL RESEARCH ASSOCIATE - Ohio / Kentucky

At Abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. Today, 72,000 Abbott employees are doing work that matters.

The territory is based in the Midwest Region and will cover Ohio and Kentucky. Abbott Laboratories is seeking a Regional Clinical Research Associate (RS-CRA) for a their US Clinical Field Operations Team. The RS-CRA will be directly responsible for conducting site qualification, initiation, interim monitoring and study closeout visits in accordance with all applicable regulations, guidelines, and business processes and will monitor the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas. Report monitoring activities and study site conduct via written reports. Interact and build professional and collaborative relationships with all study personnel, peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with Abbott and site personnel. The RS-CRA will partner with other Abbott personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Abbott US Clinical Field Operations and create a positive work environment by encouraging mutual respect, innovation and accountability at all levels. The RS-CRA will be responsible for assignments of greater complexity (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. Additionally, the RS-CRA may train and provide guidance to junior staff. Position functions in an independent and regionally based capacity.

QUALIFICATIONS:

Skills/Experience Requirements:

- Demonstrate strong site management and monitoring skills
- Exhibits strong planning and organizational skills and the ability to work effectively and
efficiently in a dynamic environment with competing projects and deadlines
- Excellent written and verbal communication skills
- Acute observational skills, analytical and conceptual capabilities
- Exhibit high degree of flexibility when facing changes in the work environment
- Proficiency in the use of personal computers, including experience with EDC, CTMS, word
processing, spread sheets, email, and web-browser applications
- Strong ability to work independently with minimal supervision
- Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines
and/or federal regulations, and applicable local regulations
- Ability to 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 and or present at departmental or investigator meetings. Participate in special
projects/work groups
- Build relationships with current investigators and identify, evaluate and recommend
new/potential investigators/sites on an on-going basis

Qualifications:
Minimum of 5 years of clinically related experience, of which 3 years must be in clinical research monitoring. Candidates with lesser experience will be considered.

Preferred Qualifications

- Experience in multi-therapeutic areas preferred - MS, MA, MBA, MPH desired

Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence. Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference. Through our diverse healthcare businesses, we connect people and potential in ways that no other company can.

Discover a world of opportunities at Abbott.

 EEO Statement:

At Abbott, we believe that diversity drives innovation. Innovative thinkers who are passionate about the work they do, Abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.