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 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 to maximize recruitment in all enrolling trials
Minimum Qualifications:
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.
Ready to Kickstart Your Sales Career with Home Genius Exteriors?Are you a recent graduate looking to jump into a dynamic sales career? Do you have a competitive mindset and love interacting with new people? Home Genius Exteriors is expanding and needs ambitious, energetic...
...Job Description Job Description Seeking full-time route driver helper to help pickup donations. The driver helper must be trustworthy, hard-working, and very dependable to help pickup charity donations throughout the surrounding suburbs in the XXX area....
...will be conducted via MS Teams. Job Description: The Recruiter II will utilize a consultative and strategic approach to support... ...responsibilities and forecasting. Ensure policies, processes and legal requirements comply with local labor laws and company standards...
...Customer Service Specialists, Database Engineers, Information Systems Security Officers, Information Systems Security Engineers, SharePoint... .... Job Description: * Our Team is looking for a SQL Database Administrator to maintain the integrity, security, and availability of...
...Job Description Job Description Job overview: We are seeking a detail-oriented and reliable individual to join our team as a Mail and Payment Processing Associate. This vital role is responsible for handling all incoming mail, including patient, insurance and client...