Clinical Research Coordinator

The Clinical Research Coordinator (CRC) is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials. The CRC plans, coordinates, evaluates, and manages the care of both the participants and of the data for their assigned trials. The CRC follows study specific protocol guidelines 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 in accordance with company policies, Standard Operating Procedures (SOP), 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.
• 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.
• Maintain timely internal source documentation as well as sponsor-required information.
• Maintain timely EDC data entry and query resolution.
• Maintain timely internal study tracking metrics of patient visits and study information.
• Complete Verification of subjects before consenting.
• 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 Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed

Recruitment Responsibilities

• Participate in recruitment planning meetings prior to study start
• Communicate all updates to Sponsor and recruitment team
• Maintain weekly communication with recruitment team in order to maximize recruitment in all enrolling trials

Secondary Responsibilities

Maintains Quality and Accuracy Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (SOP)
• Assisting in establishing and enforcing departmental standards
• Contributes to team effort by
• Working with practice staff to resolve issues
• Exploring new opportunities to add value to the organization and departmental processes
• Helping others at the practice to achieve study goals
• Performing other duties as assigned
• Support the organization’s mission and goals
• Maintains Technical and Industry Knowledge by
• Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings

Additional skill set:

• Strong motivational skills and abilities
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain a professional and positive attitude
• Detail oriented
• Strong critical thinking skills
• Strong ability to multi-task
• Strong computer skills
• Ability to support and demonstrate the mission and goals of the company
• Excellent interpersonal and customer service skills
• Knowledge of medical terminology and clinical practices

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.

Experience

• CRC in Clinical Research or relevant clinical role required
• Associate's or Bachelor’s degree required, Foreign trained MD applicable

Job Type: Full-time

Pay: $40,000.00 - $50,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• Clinical research: 1 year (Required)

Work Location: In person