Sr Associate Clinical Research

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

SENIOR ASSOCIATE CLINICAL RESEARCH (Senior Clinical Research Associate) 12/24/2019

Primary Function

Manages all aspects of the daily operations of clinical studies, including multi-center domestic, international, and/or multiple small studies at one time with minimal oversight.

Manages the activities of clinical study teams and investigative sites as they relate to Abbott Nutrition clinical studies including pilot, proof of principle, therapeutic nutritional, pediatric nutritional and efficacy studies to ensure successful execution of the protocol on time, within budget and in accordance with country-specific regulations, ICH Guidelines of Good Clinical Practices (GCPs), and Abbott's Standard Operating Procedures (SOPs).

Primary Responsibilities

Study Management

• Provides effective project leadership in the planning and execution of studies by taking responsibility for the completion of Clinical Operations (Clin Ops) review and feedback on protocol development, source documents development, case report form design review, informed consent design and review, investigator selection, investigator training, contract review, vendor/CRO management, supply management, data collection, and query resolution with oversight from Clin Ops management.
• Chairs team and 1:1 meetings with the CRAs/Monitors to review site status, issues, study timelines and ongoing data quality. Leads Clinical Study Team meetings, as appropriate. Ensures meeting agendas and minutes are produced in accordance with the meeting schedules.
• Ensures site and team adherence to intended timelines, including development of clinical study documents, enrollment, delivery of clinical supplies, and data delivery.
• Ensures timely essential document collection and review; supervises activities of the document specialist as needed.
• Assists in review and management of study and/or site budgets
• Provides effective oversight of study vendors including labs and CROs to assure quality work product and that timelines are being met.
• Anticipates/recognizes problems in advance of potential study milestone delays and contributes to problem solving, risk mitigation and contingency planning at site and study team level (in collaboration with Clin Ops management) to ensure successful completion of study according to timelines and budget in support of program objectives. Anticipates and proactively solves study-related issues as they occur and initiates, recommends and communicates corrective action as indicated. Ensures that follow-up to corrective action is taken at the site and is properly documented.
• Actively contributes to and chairs one or more R&D process improvement committees to increase the quality, productivity, and efficiency of Abbott procedures.
• Mentors, coaches and provides guidance to and trains less experienced clinical team members. Provides timely corrective performance feedback to monitors and CRAs as needed. Escalates ongoing performance issues to appropriate manager.

Study Monitoring

• Expert in the following Monitoring Responsibilities: Conducts and/or supervises monitors in conducting site qualification, initiation, interim monitoring and study closeout visits for studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott SOPs and business processes.
• Conducts, and/or manages the monitors in conducting, assigned 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:
  • Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.
  • Manages the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.
  • 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 according to the monitoring plan, Abbott SOPs, ICH Guidelines, and federal regulations.
  • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
  • Appropriately escalates serious or outstanding issues to the study team and management.
  • Facilitates Quality Assurance Audit processes as indicated.
• Reports, and/or manages the monitors in reporting, monitoring activities and study site conduct accurately and completely. Prepares and submits written reports and approves monitors' written reports in a timely, concise, objective, and consistent manner across all study sites.
• Identifies, evaluates and recommends new investigators/sites on an on-going basis. Potential sites may be identified through networking or internal Abbott requests to assist in the
• placement of planned clinical studies with qualified investigators.

Travel

30 - 70% of time.

Experience

Bachelor's Degree required; medical/science/nursing background is preferred, masters or other advanced degree desired. Minimum of 5 years of clinically-related experience of which 3 years must be in clinical research monitoring (on-site monitoring of nutritional, investigational drug or device trials).

Skills

• Team leadership skills. Proven track record of successful management of all activities from pre-study activities to study completion for a multi-center domestic or international study or multiple smaller studies of less complexity (delivered on time, within budget, and with high quality).
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Good written and verbal communication skills, acute observational skills, analytical and conceptual capabilities.
• Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications, electronic data capture systems, clinical trial management systems, and Sharepoint.

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