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- Supports in the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded, and reported in accordance with the protocol, 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.
- Participates in the study startup activities and site opening activities as well as study conduct and site closure tasks.
- Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision.Ensures 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. Ensures safety and protection of study subjects.
- Supports and/or conducts (accompanied) site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes, if applicable. Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. Appropriately escalates serious or outstanding issues.
- Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites. Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, with appropriate supervision. Keep management informed of study progress through periodic updates.
- Supports with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required. Supports remote monitoring, if and as applicable.
- Assists in study budget preparation and clinical study agreement execution, including ensuring necessary payments are made according to executed agreements. Negotiates investigator/ hospital agreements with stakeholders. Maintains and completes own expense reports as per local and applicable guidelines. Supports new and innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs.
- Appropriate life-science or healthcare-related qualification or experience or equivalent work experience.
- One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials is preferred
- Knowledge of conducting industry-sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelines and applicable local regulations is preferred.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study-related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
