Location: Bala Cynwyd, PA
Organization: ACI Clinical
Job Type: Full Time - Regular
Description and Requirements
ACI Clinical is a leader in endpoint adjudication committees. We are seeking highly competent, self-motivated individuals who can support clinical needs in all study phases. The Clinical Specialist is able to collaborate effectively with medical experts, provide leadership and expert guidance, while defining and articulating the study needs in a wide range of therapeutic areas. The Clinical Specialist also possess good judgment with well-developed critical thinking and decision making skills.
RESPONSIBILITIES:
Serves as a clinical resource on multiple projects, assuring quality supporting information is provided to our medical experts.
Perform tasks for assigned projects according to defined budget and timeline for designated workflows
Primary responsibility for clinical review to assure data completeness and accuracy, consistency, logic, medical accuracy, patient safety and protocol compliance
Clinical review of case content that includes source documents such as procedure reports and hospitalization summaries
Provide clinical support for panel meetings, including documentation of decisions, coding and preparation of clinical summary
Perform (serious) adverse event reconciliation
Perform coding of adverse events, concomitant medications and medical history
Provide clinical support in project meetings
Supports and understands the customer’s needs and desired outcomes
Support study close out activities
Assists with the clinical aspects of charter development
Assists in defining event identification processes
REQUIREMENTS:
BS/BA required or equivalent experience; nursing degree preferred.
At least three (3) years pharmaceutical industry research or adjudication experience; CRA or nursing experience preferred.
Experience in technical writing skills preferred.
Superior organizational skills.
Excellent attention to detail.
Outstanding communication skills.
Ability to handle fast-paced environment.
ABOUT US:
ACI Clinical, a member of the WCG Clinical family, is a specialty provider of clinical trial committees and clinical trial advisory services. ACI maintains deep involvement in several public-private thought leadership efforts to improve the quality and effectiveness of clinical trials by enhancing data integrity for regulators and the scientific community to drive efficiencies in clinical research and enable more informed decision-making.