Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
PRIMARY JOB FUNCTION:
Develops, analyzes and evaluates the execution of moderately complex human clinical research studies required to enter new products into the marketplace or to expand product claims, in compliance with state and federal regulations and corporate policies. Effectively manages multiple clinical sites (10-20) to assure accurate and timely completion of studies, including developing project timelines and budgets.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional policies and procedures.
May independently research background for study and propose study design to manager. Under minimal supervision, may write global clinical plans, protocols, and investigator brochures. May obtain completed prestudy documents from investigative sites. Ensures that all study documentation are properly reviewed, approved and filed. May request manufacture, labeling and shipment of study materials; may approve draft labeling of investigational supplies. May identify and qualify investigators for potential study site. May coordinates Institutional Review Board/ Ethics Committee approvals. May supervise a nonexempt employee or Clinical Research Assistant.
May trains site staff in study conduct and may be a primary contact for site communication. Monitors case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol. Informs manager of adverse events and study progress; ensures that final CRFs are accurate and complete; verifies and approves data listings. Monitors progress of studies by communicating with sites and other CRAs.
Ensures sites complete studies on a timely basis. Ensures stock of clinical supplies is sufficient to meet study needs. May lead a team of CRAs in study execution; may be a member of an R&D project team. Determines the need for and conducts site visits alone or with other CRA to monitor procedures, protocols and progress of studies.
Ensures availability of all final study documentation in case of FDA or other regulatory body, notified body or internal QA audit. May independently review key variables and comments and may present recommendations at technical review meetings. May interpret study results, may write or contribute to final reports, and may obtain approvals. May present or assist in presenting study to FDA.
PROJECT TEAM PARTICIPATION
May represent Clinical Research Department at project teams to which assigned. May provide input relative to study design, risk analysis and appropriate clinical consultation to team relative to therapeutic area.
May participate in the study planning and budgeting process to enhance knowledge in the areas of study management, budget preparation and project management. May support study payment activities or accruals. May be responsible for purchase of study equipment/supplies.
Attends related courses, seminars and meetings. Reads professional journals and publications to stay abreast of regulations and study management and to learn scientific area. Obtains information from the field on relevant new scientific developments and identifies needs for staff training. Arranges for or conducts training on medical or regulatory issues. May write and publish professional papers for the CRA community. May serve as a department resource for general study-related issues.
POSITION ACCOUNTABILITY / SCOPE:
Accountable for the successful execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures. Scope includes communication with investigational sites regarding study conduct, assisting with study design and development of study documents, which may include contracts, protocols and reports. Reports to Clincial Research Manager/Sr. Manager/Director. Works with relative autonomy and very little supervision required.
BioSpace.com - 13 months ago
Filling baby bottles and treating disease... these are the habits of Abbott. Abbott Laboratories is a top health care products manufacturer....