JOB SUMMARY:

Clinician Services Engagement Associate works in a pivotal role of managing communication and activities among clinical research sites, and internal stakeholders to prepare for and complete clinical assessments in accordance to the project specific scope of work. The successful incumbent provides quality customer service and assures that activities related to assessments are performed and delivered on time and according to client expectations.

EDUCATION REQUIREMENTS: Bachelor’s Degree in health care, life sciences or related field or equivalent work experience in pharmaceutical/ biotechnology industry.

QUALIFICATIONS/EXPERIENCE:

At least 2 years of previous clinical research trial or related experience.

Experience working directly with sponsors and sites with a proven record of successfully managing clinical assessments related projects preferred.

Experience working with psychiatric (e.g. depression, anxiety) indications is a plus.

Must possess basic knowledge of the clinical trial process, GCPs, FDA, regulations, and related clinical terminology.

Knowledge of IRB regulations is a plus.

Proficient in using office management software with the ability to manage databases, generate reports, and analyze data.

Experience with an eCOA platform is a plus.

Technical skills and ability to troubleshoot hardware, software, and network issues.

Ability to work independently and cross functionally in a fast-paced environment and support multiple projects concurrently.

Excellent organizational, prioritization and time management skills.

Excellent communication, and problem-solving skills.

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.

Partner with external customers such as clinical research sites, and internal customers such as clinical science, and clinician services to successfully deliver the services as outlined in the scope of work related to clinical assessments.

Ensure the Company standards and expectations in the Clinician Services are met and adhered to as measured by visit availability, wait times, clinician utilization, and safety reporting compliance.

Manage multiple clinical trials simultaneously while ensuring that assessments are scheduled, initiated, and completed following the study protocol requirements and design.

Provide study administrative support such as data entry, report generation, and database management.

Develop and maintain positive relationships with study participants, healthcare professionals, and other stakeholders. Provide basic technical support for hardware, software, and network issues to sites, as needed.

May develop project specific manuals for the Assessment Solutions team as outlined in the study scope of work to ensure contracted services are clearly outlined as required.

Independently investigate, resolves, and/or escalates issues to the appropriate internal team members.

Assist with the onboarding of new clinical research sites by helping with tasks such as site training, testing of equipment, and mock assessments.

Monitor query notification and resolution process with sites to ensure and protect data integrity.

Monitor reports to track subject visits and ensure compliance with risk reporting processes.

Review protocols to support custom report generation for monitoring and tracking of data captured in the clinical eCOA system.

Develop and implement new strategies to mitigate any risk that could lead to study protocol deviation.

Monitoring for the alerting of Investigators/Sites, Clients and the Clinical Science team and designated personnel when a patient risk has been reported and ensuring that the risk has been acknowledged by both the Investigator/Site and Client.

May assist with the development of site facing IR documents as well as internal project plans specific to the Assessment Solutions services provided as detailed in the project scope of work.

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.

TRAVEL REQUIREMENTS:  Up to 5% based on business needs.

PHYSICAL DEMANDS:  The physical demands 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 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.

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