Job description

Clinical Studies Support Coordinator (12 month contract // Boulder, CO):

Alternate title: Clinical Lab Study Coordinator

Initially it will be on site 5 days/wk, but will likely taper and allow for some hybrid flexibility as the project is up and running smoothly.

Top Skills/Experience needed:

Implement a study subject recruitment and screening plan

Establish key community relationships

Ensure subject compensation

Description:
In this exciting role as a Clinical Lab Study Coordinator, you will have primary responsibility to manage day-to-day operations within the client’s physiology lab. This is a coordinator role reporting to the Clinical Lab Manager. The Clinical Lab Study Coordinator will independently maintain subject recruitment, screening, scheduling and compensation responsibilities including developing and managing community outreach and laboratory advertising programs. The Clinical Lab Study Coordinator will manage clinical study databases and assist with the drafting, distribution and tracking of study paperwork; case report forms, and informed consents and assist in the laboratory and clinical study operations through maintenance of procedures in one or more of the following areas: production, research and development, quality control/assurance, and/or compliance/environmental safety.

Duties:

• Implement a study subject recruitment and screening plan, including establishing key community relationships and ensuring subject compensation.
• Work within the local community to develop a diverse subject pool.
• Establish and maintain regular communication with research management and product managers
• Develop and maintain appropriate study scheduling tools for subjects and projects.
• Conduct laboratory support functions such as ordering, stocking, and distributing supplies and equipment, and collecting, washing, and storing equipment.
• Maintain organizational standards: GCP, GLP, CITI training.
• Prepare and maintain general laboratory quality controls and appropriate auditable documentation
• Collaborate in study conduct and study subject communication, interactions, and ensure confidentiality.

Must Have:

• Bachelor’s degree with 2 years of clinical trials/clinical research/lab experience or advanced degree with of 1 year of clinical trials/clinical research/lab experience

Nice to Have (Preferred Qualifications):

• Advanced degree (Masters, or PhD) preferred. life sciences or related medical/scientific field or communications, marketing, or advertising.
• Experience in pre-market/investigational and post market studies.
• Experience with database management, subject recruitment and consenting, data collection, and clinical reporting.
• Knowledge and familiarity with the operations of a medical research laboratory.
• Ability to follow established guidelines/procedures for the preparation of various administrative forms, as well as learn new tasks independently.
• Able to read and interpret technical procedures and regulatory requirements.
• Experience in medical device clinical product trials and governing regulations.
• Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial.
• Proficient knowledge of clinical research study processes and study design.
• Knowledge of data analysis techniques, including basic statistical methods

Competencies:

• Leadership skills include strong communication, sense of urgency, high accountability, problem solving, quality focus, business integration acumen, and change management.
• Demonstrated ability to work effectively on cross-functional teams.
• Experience in a high-demand and fast-paced environment.
• Strong problem-solving skills.

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Boulder, CO: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• medical device clinical lab: 2 years (Preferred)
• implementing a study subject recruitment and screening plan: 2 years (Preferred)
• establishing key community relationships: 2 years (Preferred)
• ensuring subject compensation: 2 years (Preferred)
• clinical lab operations (GCP, pre-market: 2 years (Preferred)

Work Location: One location

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