Clinical Research Associate

Overland Park, KS, USA Req #1144
Wednesday, October 21, 2020
Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS, Seattle, WA and Philadelphia, PA.
 
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.
The Clinical Research Associate (CRA) will report to the Director, Monitoring Services. The CRA will perform monitoring and site management activities for clinical research projects to assess the progress of clinical projects at assigned investigative sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Clinical Monitoring Plan, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. 

Identify investigators.
Create Clinical Monitoring Plans (CMP)
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance. 
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP
Assesses site processes
Conducts Source Document Review of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required/appropriate. 
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Perform investigational product (IP) inventory, reconciliation and reviews storage and security. 
Facilitate audits and audit resolution.
Process and track SAEs.
Review study protocols and Informed Consent forms.
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.

Minimum of 2 years of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring or equivalent experience.
Knowledge of clinical research industry, terminology and practices.
Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Strong verbal and written communication skills.
Familiarity with EDC systems; ability to learn required systems quickly and to train others, especially site staff. 
Ability to meet deadlines, multitasks, and prioritize based on study needs. 
Ability to make sound decisions based on available information. 
Ability to establish and maintain a good working relationship with site personnel/ colleagues. 
Ability to work both in a team and independently. 
Ability to facilitate team meetings and teleconferences. 
Ability to present at internal study team meeting(s). 
Proficient with Microsoft Office Word, Excel and Power Point.
Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. 
Ability to travel 

Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

Altasciences  uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.gov.

Other details

  • Job Family Valide Positions
  • Pay Type Salary
  • Overland Park, KS, USA