Snabbfakta
-
- Maidenhead
Ansök senast: 2024-11-27
Senior Clinical Research Associate
Job Description
- Reporting to Clinical Operations Manager.
- Homebased position with 25% - 50% travel.
- Comprehensive salary, bonus and benefits package.
Role overview:
The Senior Clinical Research Associate (CRA) will enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of Clinical Site Management deliverables involving startup, execution, and closeout of studies.
Key Responsibilities:
- For assigned sites/study(s), ensure successful protocol level execution of Clinical Site Management deliverables involving startup, execution, and closeout. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
- Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Ensure audit and inspection readiness of assigned sites. Advise on preaudit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
- May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
Qualifications
- Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Extensive Site Monitoring Experience.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
- Demonstrated business ethics and integrity.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Fler jobb från Talent
