WIRB-Copernicus Group

ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.

WHY WE LOVE WCG: At WCG, our employees are our most valuable asset, and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health to help make the most of their future.

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
• Employee Assistance Programs and additional work/life resources
• Referral Bonuses and Tuition Reimbursement
• Flexible PTO
• Volunteer Time Off to benefit the community
• Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement

The expected base salary range for this position is $87,480 to $136,000. This salary range may vary based on the candidate’s qualifications, experience, skills, education, and geographic location.

SUMMARY OF POSITION: The Clinical Scientist-eCOA supports development of electronic clinical outcome assessments (eCOA’s) from a clinical perspective across therapeutic areas in conjunction with IT Development, Operations Management, and Clinical Science. The Clinical Scientist-eCOA will be responsible for ensuring timely completion of electronic scales while adhering to quality standards and clinical validity. This individual will have experience conducting assessments as well as interacting with investigative sites and study sponsors. The incumbent will assist in ensuring the organization’s operational efficacy and excellence by working with the different operational units in translating groups’ business requirements to particular software requirements and/or procedural workflows.

EDUCATION REQUIREMENTS: Graduate degree in psychology, social work, counseling, psychiatric nursing or related field.

QUALIFICATIONS/EXPERIENCE:

• Minimum 4 years’ experience administering standardized assessment tools, psychiatric symptom rating scales and/or Neurocognition scales, experience with structured diagnostic interviews preferred.
• Minimum 2 years’ experience in a clinical trial or research setting or other clinical setting is highly preferred.
• Knowledge of scale development and clinical assessment best practices.

·     Fluent in English, bi-lingual or multi-lingual skills are preferred.

• Basic understanding of GCP.

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.

• Provide clinical subject matter expertise in the development of eCOA’s to meet the client’s business needs.
• Communicate and coordinate effectively with internal teams to deliver requirements for electronic form layout, interface and validation rules/edit checks.
• Provide support to the Business Analyst and Test teams through Clinical validation expertise to test, validate and evaluate work completed by the eCS team.
• Participate in team meetings and communicate regularly with remote staff and other employees.
• Review and evaluate data collected through eCOA platforms, Independent Ratings, Independent Review, internal usability testing, surveys, and marketing research to improve functionality and clinical guidance included in eCOA’s.
• Liaise with sponsors and scale authors, as needed.
• External facing clinical representative responsible for presenting eCOA batteries utilized in large, international clinical trials, to sponsors for approval/adoption.
• Work with the operational groups who test, validate and evaluate new applications and functions, and determine clinical related issues in services and software.
• Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements related to eCOA development.
• Perform other job duties as assigned by management.
• Ability to multi-process, delegate project tasks.
• Advanced skills in MS Word, Excel, and Adobe.

TRAVEL REQUIREMENTS: Ability to travel domestic and internationally, approximately 10% of the time, including overnight stays as necessary, consistent with business needs and office location.

Physical and Sensory Requirements:  The physical and sensory requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding).  Majority of time is spent in a seated position with frequent opportunity to move about at will.  Activities require a variety of easy muscle movements.  Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively.  There will be a need to attend to single or simultaneous tasks where accuracy of details is important.  The need for detailed and precise work is high.