Position Title: Clinical Affairs Specialist

Effective Date: 01/01/2024

Reports To: Head of Regulatory Affairs

Position status: Exempt Full Time

Primary Function:

The Clinical Affairs Specialist is responsible for ensuring that our products and procedures adhere to clinical compliance standards. Knowledge of IVD CFR codes and operating within FDA regulatory rulings required.

Essential Duties and Responsibilities:

• Prepare required submission documentation to the IRB.
• Ensure that all safety reporting during and after the clinical trial are complete.
• Support data analyses and publication/presentation generation.
• Assist with enacting communication plan and creating data report template for CRO.
• Participate and coordinate the planning, development, and implementation of clinical protocols, administrative and logistical procedures, and documentation.
• Coordinate the collection, processing, and recording of clinical data and/or specimen samples, as required by established study protocols.
• Undertake any other reasonable duties required of the position in support of Molecular Testing Lab’s submission needs to regulatory bodies.
• Assist with clinical data collection, trial monitoring, and auditing, according to GCP guidelines and study SOPs.
• Assist the planning. Scheduling, and carrying out of day-to-day clinical activities and procedures, ensuring an efficient workflow.
• Maintain proactive and positive working relationship with internal and external personnel to ensure the business is positioned to meet strategic corporate goals.
• Other duties as assigned.

Skills, Knowledge, Abilities:

Mental Abilities and Skills Requirements-

• Excellent interpersonal, written / verbal communication and organizational skills.
• Ability to self-motivate and prioritize required tasks to keep track of and meet deadlines.
• Ability to pivot between multiple projects easily, quickly, and accurately.
• Strong interpersonal and communication skills and the ability to work effectively with a range of constituencies.
• Knowledge of the principles and procedures of clinical research.

Knowledge Needed-

• Comprehensive understanding of applicable GCP, ICH, FDA, and other internal regulations.
• Advanced experience in communication and submission to Institutional Review Boards (IRBs)
• Advanced computer skills including spreadsheet generation, word processing, database management, PowerPoint, and other necessary applications.

Education and Certification:

Education/Experience Requirements-

• A bachelor’s degree in a scientific discipline; advanced degree preferred. Candidates with professional certifications relevant to the studies and with exceptional experience will be considered.
• 1 year minimum experience in clinical research.
• Must be able to work onsite at MTL in Vancouver, WA (some flexibility with work from home days)

Certifications-

• Certified Clinical Research professional (CCRP) or equivalent certification preferred.

Physical Requirements:

• Must be able to sit or stand for up to eight hours per day.
• Occasionally required to lift up to 20 lbs.
• Regularly required to sit, stand, bend, reach and move about facilities.

Work Environment:

VANCOUVER OFFICE - Most work will be performed in an office. However, this position may require some traveling and working between locations. Workweeks usually consist of 40 hours.

Office Environment-

• Several common areas and meeting rooms for collaboration.
• Large windows which let in natural light during working hours.
• Fully equipped break room and bathrooms.

Lab Environment-

• Noise levels vary based on flow of business.
• Most floors are tile or concrete - individuals may stand for extended periods of time on these surfaces.

Tools and Technology:

• Desktop computer and laptop
• Scanners and printers

Hazards:

• Work is performed in an office environment, full manual dexterity and visual acuity required. However, access to the laboratory may be necessary and therefore employee may be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools, and equipment.
• Hep B Vaccination provided at no cost to employee.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by associates assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Molecular Testing Labs embrace diversity and is an Equal Opportunity Employer, and hire without regard to any individual's race, age, color, national origin, ancestry, disability, veteran status, religion, marital status or domestic partnership; pregnancy, childbirth or related medical conditions; other medical conditions or genetic characteristic; sexual orientation, gender, gender identity or transgender status; or any other basis protected by state, federal or local law, regulation or ordinance. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Molecular Testing Labs provides reasonable accommodation upon job seeker request in all steps of the employment process.