JOB DESCRIPTION:Summary The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.
Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site's recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.
Main Responsibilities With limited direction from leadership:
1. Develop and maintain a productive clinical territory: Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.
Understand and assess investigators' interests and qualifications.
Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel.
Provide ongoing technical support to customers and field staff.
Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.
2. Manage all aspects of study lifecycle to include site regulatory and quality: Start Up
Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
Facilitate all aspects of the start-up process and site initiation visits
Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.
Train facility staff regarding protocol requirements and technology.
Enrollment
Develop site-specific strategies to promote appropriate patient enrollment.
Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
Continuously evaluate site study performance and provide timely feedback to site.
Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
Regulatory and Quality
Core level Abbott certification and/or equivalent level proficiency
Develop site-specific strategies to avoid deviations.
Educate site on tools to facilitate compliance.
Provide timely feedback to the sites on key compliance indicators.
Escalate non-compliant sites according to corporate policy.
Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
Review data and source documentation from investigational sites for accuracy and completeness
Facilitate resolution of data queries and action items at clinical sites
Promptly reports the findings of monitoring visits according to Abbott processes.
Maintain accurate, detailed and complete records of monitoring visits.
3. Provide training and procedure coverage: Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
As needed, provide clinical and technical expertise for clinical trial procedure support
Attend study procedures and follow-ups (or ensure trained personnel attend).
4. Collaborate with commercial partners: When appropriate, collaborate in the education of local sales groups on new product launches.
When appropriate, contribute to the education of customers on new and existing Abbott products.
Meet with key customers where Abbott GCO presence can elevate the customer experience.
Act as an additional resource for technical questions and troubleshooting.
5. Identify and adapt to shifting priorities and competing demands. 6. Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence. Maintain at least one area of expertise and function as a local clinical and technical resource.
7. Possess independent problem-solving skills and ability to make decisions. 8. Exhibit excellent oral and written communication skills. REQUIRED QUALIFICATIONS Education - Associates Degree (± 13 years)
Experience/Background PREFERRED QUALIFICATIONS - Bachelor's Degree Or Master's Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.
- 2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
- Competency in catheterizaion lab and operating room protocol and procedures.
- Ability to travel approximately 75%, including internationally.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Clinical Affairs / Statistics
DIVISION:MD Medical Devices
LOCATION:United States > California : Remote
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 75 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment
