Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose:

Support the conduct of clinical research trials at the AbbVie Clinical Pharmacology Research Unit (ACPRU) in accordance with all Regulatory and AbbVie requirements by having responsibility for records management at the ACPRU. This includes managing the GCP clinical site documentation activities, such as facilitating study protocol reviews, drafting informed consent forms, coordinating and submitting the IRB and sponsor trial master files, and managing the essential documents (EDs) at the ACPRU. Provide guidance and oversight to direct reports. Ensure Institutional Review Board (IRB) approvals are received on time for study start up. This role is the liaison for the ACPRU and the sponsor clinical teams as well as between the ACPRU and the IRB.

Description:

• Supervise maintenance of ACPRU Records Room, including creating charts, filing documents, record accountability, and offsite storage processing. Manage the ACPRU Records Room processes. Act as ACPRU Records Coordinator ensuring clinical trial records are complete and stored in controlled storage areas at J50. Work with AbbVie Records Management when changes impact ACPRU processes. Create and implement process changes for the ACPRU.
• Supervise the creation, collection, maintenance, and submission of EDs for clinical studies conducted at the ACPRU. Manage the ED processes. Work with Document Management and SM&M when changes impact ACPRU. SME for the ACPRU electronic ED system.
• Draft ICFs for internal review. Submit ICFs to IRB and make decisions on IRB requested changes. Maintain templated IRB-required language. Ensure all ICFs are reviewed by IP Legal and the PST Lead for appropriate safety language and documentation of acceptance is maintained in the ED. Review protocol amendments and administrative changes for impact on ICF. Ensure revisions are made when necessary. Review all open study ICFs when updated safety language is received for a particular compound.
• Manage draft protocol reviews and combine comments to provide to CPPM/clinical team. Act as liaison between ACPRU and CPPM/clinical teams regarding edits to the protocols; making decisions on changes based on impact to the ACPRU. Ensure consistency in study protocols. Lead project teams for protocol template reviews.
• Prepare and submit documents to the IRB, as well as oversee submission of documents to the IRB. Manage IRB submissions and scheduling by working closely with the IRB and clinical teams and ensure IRB approvals are received on time for study start up. Process IRB documents and approvals. Ensure studies are closed out with the IRB per IRB, SOP and GCP requirements.
• Maintain professional communication and interaction throughout all aspects of work at the ACPRU, with clinical teams and outside customers (i.e., IRB representatives). Effectively communicate with all levels of AbbVie management.
• Continually assess ACPRU records management activities for compliance to the study protocol, departmental SOPs, and ICH GCP and FDA regulations. Review documentation for study files to ensure compliance with SOPs and alert CPPM Quality of noted study issues with potential CAPA requirements. Develop CAPAs. Identify, develop, and implement process improvement changes for records management. Lead records management projects, including electronic systems, and have responsibility for results.
• Facilitate ACPRU process review meetings and develop process flows using Lean Six Sigma (LSS). Generate ACPRU performance metrics reports.
• Achieve the desired outcome of activities with little or no guidance. Work independently as well as in teams. Must be able to make sound decisions based on situation at hand, provide direction to clinic staff and clinical teams and assume responsibility for the outcome of the decision. The job requires knowledge of quality principles, research, and an understanding of the effect of his/her decisions on it.
• Supervise 0-4 non-exempt direct reports. Manage and guide conduct of employees and written communication.

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

*This position will be required to be on-site 4 days / week*

• Bachelor's preferred or Associates Degrees required with relevant work experience
• 5 years’ experience in medical environment or health care organization. • 5 years’ familiarity with clinical research or quality assurance and with AbbVie quality assurance, clinical research or R&D systems.
• 2 years’ experience with using windows-based word processing, spreadsheet, presentation, graph and table software required. Database experience preferred.
  • 2 years' familiarity with CAPA process
  • 5 years' familiarity with medical terminology or regulatory documents. •
  • 5 years' proven ability to work in a team atmosphere required.
• Possess knowledge of records management, excellent attention to detail and strong organizational skills to meet timelines and work on multiple projects simultaneously.
• Must be able to anticipate and adjust to rapidly changing priorities, anticipate the impact of the change on overall project(s), and make decisions on changes needed to obtain the desired outcome.
• Good judgment, professionalism and independence are needed in interacting with coworkers and clinical project teams. Needs to have the ability to show good judgment in trading off the need for more information with the necessity of making timely decisions. Must be able to use good business judgment when implementing solutions independently and be able to use good business judgment to discern which issues should be raised with management for approval.
• Must have a thorough knowledge of the applicable regulations and be able to apply them to a wide variety of situations, propose potential solutions to management and clients and implement accordingly.
• Must take initiative and identify and implement new approaches to resolve problems.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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