Job Title: Clinical Trials Scientific Affairs Specialist

Department: Scientific Affairs

Location: Remote

Hours Per Week: 40

Schedule: Monday - Friday; 8:00 AM - 5:00 PM EST

SUMMARY

The Clinical Trials Scientific Affairs Specialist spports the Clinical Trials Scientific Affairs (CTSA) Director in scientific, technical and business oversight of ACM Reference and Third Party Labs.

RESPONSIBILITIES

• Perform data entry and lab result/tracking of reference laboratory data as assigned on behalf of ACM Global Laboratories. Facilitates information discovery, procurement and maintenance as needed to support ACM Test Catalogue.
• Interact with the CTSA director and as assigned prepares opportunity specific price and service negotiation, and project oversight as it relates to scientific and technical capabilities of the Third Party laboratory operations.
• Monitor reference laboratory communications.
• Lead ACM impact assessment of third party lab change control and integrate reference laboratory change into ACM change control processes.
• With CTSA Director oversight anticipates in strategic sourcing, capabilities development, and financial-related issues as assigned.
• Assist the CTSA Director in study oversight activity as assigned for strategic reference laboratories.
• Oversee new assay / validation progress for reference laboratories.
• Work with ACM QA and CTSA Director in facilitating quality investigation and root cause analysis as it relates to reference lab quality investigation issues.
• With direction and guidance of CTSA Director, participate in the initial and re-qualification of reference laboratories.
• Participate in ACM reference laboratory governance procedures, scheduling and follow-up on action items as assigned.
• Complete technical and scientific related special projects.
• Collaborate with business development, ACM leadership, and clients as well as other internal departments on new business timelines, technical and compliance issues, and project-related matters.
• Participates in sourcing and establishing relationships with reference laboratories consistent with business needs.
• Integrates and maintains reference laboratory information in ACM processes, databases and services.
• Works closely with the CTSA director and leadership team in strategic planning and governance oversight.

REQUIRED QUALIFICATIONS

• 5 years combination of education, training, & experience required

PREFERRED QUALIFICATIONS

• Previous experience with clinical trials, relationship management or procurement preferred
• MT(ASCP) certification or equivalent certification preferred

EDUCATION:

LICENSES / CERTIFICATIONS:

PHYSICAL REQUIREMENTS:

S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

$72,000.00 - $95,000.00Rochester14624

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer.
Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.