The Quality Control Analyst collaborates with management and clinical site staff to develop, verify and implement procedures, in accordance with Good Clinical Practice (GCP) and Federal Regulations, that support Segal Trials in accomplishing its quality management goals. Under the supervision of the Director of Clinical Compliance and/or President, the individual in this role reviews patient and study related data to verify research protocol compliance and adherence to protocol, as well as data integrity, and data control principles. The scope of the Quality Control Analyst extends to all study-related data collection, including Clinical Trial Management Systems (CTMS), Regulatory documentation, Source documentation, Electronic Data Capture, and other systems, as appropriate.

DUTIES & ESSENTIAL JOB FUNCTIONS

• Adhere to the established SOP and Work Instructions when performing quality control review.
• Knowledge of all awarded protocols and applicable supporting manuals (i.e. pharmacy, lab, ECG, etc.) to perform quality control review.
• Perform 100% quality control review of all study related documents and ensure compliance with all study and non-study regulations including, but not limited to, the study protocol, HIPAA, OSHA, GCP, GDP, CRF and ICH Guidelines.

· Perform data comparisons between data collected during a specific clinical trial and the related protocol to ensure that generated during the study adheres to protocol requirements.

· Verify the integrity of all clinical trial data in accordance with ALCOA-C principles (accurate, legible, contemporaneous, original, accurate and complete).

· Maintain thorough documentation to confirm resolution of any issues of concern.

• Participate in study related meetings including, but not limited to, study award meetings, planning meetings, protocol training, and site initiation visits.
• Read and understand each assigned protocol.
• Track general findings from quality control source review for future improvement.
• Maintain an open line of communication on daily and weekly basis with clinical site staff and other department members.
• Escalate any critical or major findings or trends to the Director of Clinical Compliance.

· Provide regular reports to the Director of Clinical Compliance and/or President and Management Teams to advise leadership of quality issues and to guide enterprise process corrections & improvements.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES:

· Possesses exceptional attention to detail.

· Able to work independently with little feedback or direction.

· Functions well under high-pressure conditions.

· Possesses highly effective communication skills.

o Exhibits highly effective verbal and written communication skills through positive interactions with coworkers, managers, clients and vendors.

· Models team collaboration skills.

o Works effectively and collaboratively with team members to accomplish goals.

· Independently displays a passion to learn and innovate and maintains knowledge of industry development through personal readings and individual trainings.

· Balances tasks with competing priorities effectively without direction from supervisor.

· Solicits & responds positively to direction & constructive criticism from supervisors, managers, & peers.

REQUIREMENTS:

· 2+ years of relevant work experience in clinical research

· Minimum 1 year experience working in Quality Assurance or Quality Control preferred

· Previous experience working with Standard Operating Procedures development preferred

· Proficiency in English required

· Proficiency in Spanish preferred

· Training in clinical research courses preferred

· Familiarity with ICH GCP/GDP guidelines

· Proficiency with Microsoft Office, including Outlook and Excel

Who We Are?

Segal Trials, founded in 1998, is a privately held network of five research sites throughout South Florida, conducting phase I-IV research trials with a primary emphasis on psychiatry, neurology, addiction, insomnia, general medicine, vaccinations and more. With a team of over 150 professionals, Segal Trials remains agile and competitive.

Segal Trials is regarded as an innovator and a leader in the advancement of medicine with a strong dedication to the community it serves by spreading awareness about clinical trials as a potential care option.

Why Segal Trials?

When working at Segal Trials, you will be surrounded by passion, diversity, and likeminded individuals who are striving in the pursuit of excellence. We will foster your continued success and you will begin making a difference on your very first day!

For more information, visit www.segaltrials.com

Job Type: Full-time

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• North Miami, FL: Reliably commute or planning to relocate before starting work (Required)

Experience:

• of relevant work in clinical research: 2 years (Preferred)
• QA/QC: 1 year (Preferred)
• Clinical research: 2 years (Preferred)

Work Location: One location

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