Job description

Job description

The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the vision and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned trials. The CRC follows study specific protocol guideline and communicates and interacts with Investigators, clinic staff, CROs and Sponsors to effectively perform clinical research and coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, state and federal regulations.

Primary Responsibilities

· Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP and protocol guidelines.

· Identify potential problems or inconsistencies and take action as appropriate.

· Articulate protocol issues to CRO and/or Sponsor, Site Lead, Manager, Principal or Sub-Investigator, and other members of the study team.

· Collect initial subject health and demographic information by interviewing subjects and accessing other appropriate sources.

· Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator.

· Ensure a flow of communication including telephone conferences between subject, study staff, referral sources and recruitment team, Sponsor and/or CRO, Monitor(s) and Auditors, if applicable.

· Perform clinical tasks including, but not limited to: vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging.

· Dispense and maintain accurate records of investigational and study product.

· Educate subject and family members regarding specific studies and clinical drug trials in general.

· Complete all monitor and sponsor queries in a timely manner.

· Perform some phlebotomy

· Perform Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed

Recruitment Responsibilities

· Provide weekly updates to Active Studies Report
· Communicate all advertising needs to recruitment team
· Maintain weekly communication with recruitment team in order to maximize recruitment in all enrolling trials

Minimum Qualifications:

• At least 2 yrs of experience as a CRC in clinical research or relevant clinical role
• CCRC or CCRP certification preferred
• Phase 1 experience preferred

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

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 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:

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

Experience:

• Clinical Research Coordinator: 2 years (Preferred)
• Phase I: 1 year (Preferred)

Work Location: One location

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