CLINICAL TRIALS STUDY COORDINATOR

Hamzavi Dermatology•Fort Gratiot Charter Township, MI

1d•Onsite

About The Position

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.

Requirements

At least 2 years of experience as a CRC in clinical research or relevant clinical role
Strong motivational skills and abilities – promoting a team-based approach
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

Nice To Haves

CCRC or CCRP certification preferred

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.
May be asked to draw blood occasionally.
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.
Maintain timely internal source documentation as well as sponsor-required information.
Maintain timely EDC data entry and query resolution.
Maintain timely CTMS data entry of patient visits and study information.
Complete Verification of subjects before consenting.
Report hospital census data, if applicable.
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.
Send “All Users” email upon enrollment activation or enrollment closure
Participate in recruitment planning meetings prior to study start
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
Communicate the need for study or company flyers
Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
Assisting in establishing and enforcing departmental standards
Working with internal staff to resolve issues
Exploring new opportunities to add value to the organization and departmental processes
Helping others at the site to achieve site goals
Performing other duties as assigned
Support the organization’s mission and goals
Attending and participating in applicable company-sponsored training
Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings