Clinical Specialist, Research & Adjudication at WIRB-Copernicus Group in Bala Cynwyd, Pennsylvania

Job Description:

SUMMARY OF POSITION:

ACI Clinical is a leader in endpoint adjudication committees. The Clinical Specialist is a highly competent, self-motivated individual 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 possesses good judgment, with well-developed communication skills and the ability to understand the perspective of key stakeholders.

EDUCATION REQUIREMENTS:

BS/BA required or equivalent experience, nursing degree preferred.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

None

QUALIFICATIONS/EXPERIENCE:

• At least three (3) years industry experience, CRA experience preferred.


• Superior organizational skills.


• Excellent attention to detail.


• Outstanding communication skills.


• Ability to handle fast-paced environment.


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ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

• 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.


• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.


• Attendance and punctuality are essential functions of the position.

SUPERVISORY RESPONSIBILITIES:

None

TRAVEL REQUIREMENTS:

None

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successful y perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Position Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.