Clinical Research Coordinator - Full-Time, Non-Exempt

This position requires verification of Covid-19 vaccination and vaccination booster

Cosmetic Laser Dermatology, a subsidiary of West Dermatology, is seeking a Clinical Research Coordinator in the Research department of a fast-paced dermatology practice. This Clinical Research Coordinator will be responsible for all aspects of clinical research studies from patient recruitment to study close out in coordination with clinic and surgery center practices. This candidate must be committed to executing exceptional customer service with excellent listening, oral and written communication skills. This individual must be professional, tactful, mature, and able to interact effectively with diverse personalities. Time management skills and the ability to maintain confidentiality of privileged and sensitive information are also critical to this position.

Education and Experience:

• 2+ years Clinical Research Coordinator experience
• Must have subject recruitment Clinical Trial experience
• Regulatory experience preferred
• Medical Assistant or equivalent training desirable
• CPR Certified
• Knowledge of CFR ICH GCP Guidelines
• Clinical Research Certifications a plus
• Dermatology experience a plus

Essential Skills and Abilities :

• Experienced in IRB regulatory submission process and related maintenance documents
• Knowledge of GCP’s (Good Clinical Practices).
• Knowledge of Federal Guidelines
• Knowledge of the California Experimental Subject’s Bill of Rights
• Knowledge of CFR (code of federal regulations).
• Knowledge of phlebotomy technique.
• Knowledge of basic medical assisting techniques.
• Superior ability in exercising a relatively high degree of initiative, judgment and problem resolution.
• Strong organizational skills and the ability to multi-task and manage multiple clinical trials
• Possess excellent interpersonal skills and effectively communicate with patients for study recruitment
• Team player, detail oriented and self-confident with the ability to work with minimal supervision or independently
• Proficient computer skills, especially Windows, MS Office, the Internet, and medical software
• Ability to operate basic office equipment such as a phone, fax, copier, printer etc.

RESPONSIBILITIES:

• Responsible for overseeing and maintaining all aspects of clinical research trials to ensure adherence to FDA guidelines and study protocols
• Subject recruitment, screening and enrollment.
• Schedules and conducts study visits per study protocol.
• Directly collects data from subject.
• Obtains informed consent.
• Provide patient education and literature.
• Maintains source documents.
• CRF (case report form) completion and review for accuracy
• Conducts site monitoring visits and audits.
• IRB (Institutional Review Board) and Sponsor interaction.
• Work directly with P.I. or Sub-I physicians.
• Collection of laboratory specimens and documentation of laboratory and histological procedures.
• Ensures accurate labeling of slide photos.
• Documents lab results and follows up.
• Filing and maintenance of all study related documents.
• Documents adverse events and notifies principal investigator and appropriate agencies.
• Notifies sponsor and IRB of any serious adverse events.
• Assist physician with all procedures.
• Take pre and post-treatment pictures.
• Clean pack and sterilize instruments.
• Assists in cleaning rooms.
• Monitor physician’s schedule to maintain timely flow.
• Check voice mail and triage calls according to protocol the same day.
• Travels to investigator meetings.
• Participates and contributes in staff meetings.
• Other duties as assigned.

WORKING CONDITIONS:

Must be able to work with very minimal supervision in a normal medical and office environment with minimal exposure to dust, noise, etc., and be able to lift up to 25 pounds.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
All patients, staff and visitors are required to wear a mask in the practice.

Ability to commute/relocate:

• San Diego, CA 92121: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Preferred)

Experience:

• Clinical trials: 1 year (Required)
• Clinical Study Subject Recruiting: 1 year (Required)

License/Certification:

• CCRC (Preferred)

Work Location: One location

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