Clinical Research Coordinator Assistant

The Clinical Research Coordinator (CRC) Assistant will work collaboratively with a multi-institutional team. The CRC assistant will support the CRC, administrative staff and principal investigators, assist the communications between sponsor and institute, oversee details of clinical studies and ensure compliance with study review board and clinical research regulations. The CRC assistant can be part of multiple research projects and should have the ability to multi-tasks.

Duties:

• Develops and maintains knowledge and proper skills to comply with the protocol, federal regulatory requirements and internal SOPs
• Prepare and attend study meetings.
• Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
• Proactively develops and executes recruitment plans that meet and exceed enrollment goals
• Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
•  Maintains proper skills to update databases, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
• Creates and updates source documents/progress notes, and collects study data via source documents/progress notes as required by the protocol.
• Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
• Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
• Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
• Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
• Dispenses study medication at the direction of the Investigator
• Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
• Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor
• Addresses all queries or data clarifications within the time period specified by the sponsor
• Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in a timely manner during these visits
• Reports protocol violations and significant deviations to the CRCs and the investigators.
• Establishes relationships with participants, and participates through ongoing patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process
• Assists other staff members at the site as determined by the needs and priorities of the organization and as time and abilities permit
• Anticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement

Requirements

Education

• Degree in health-related field/life science with minimum one year experience in clinical research
• -    Clinical research certification GCP and IATA certification are required (or willing to obtain them within the first month of assignment). 

Basic Skills:

• Medical terminology and knowledge of disease processes
• Working knowledge of clinical research design and regulatory requirements
• Excellent interpersonal, verbal, and written communication skills. 
• Organized and detail-oriented individual.
• Comfortable working in a team environment
• Proficient in spreadsheets and clinical research software.
• Understand clinical procedures, regulations and be an excellent team player working with physicians, nurses, non-clinical, laboratory and ancillary staff
• Capability to meet data deadlines and maintain confidentiality
• Ability to travel to INSIGHT local offices when needed

• Paid Sick Time - effective 90 days after employment.
• Paid Vacation Time - effective 90 days after employment.
• Health, vision & dental benefits - eligible at 30 days, following the 1st of the following month.
• Short and long-term disability and basic life insurance - after 30 days of employment.