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
Spanish Speaking Candidate Needed

Job Type: Full-time

Pay: From $30.00 per hour

Benefits:

Health insurance
Paid time off

Work Location: In person

SCLA Management

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Clinical Research Coordinator