PH- Clinical Research Associate Job at ACL Digital, King of Prussia, PA

U0V3NUZGbm5weklGQm03alhhYW1wUjc0N3c9PQ==
  • ACL Digital
  • King of Prussia, PA

Job Description

The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product. Responsibilities

  • Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol.
  • Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research.
  • Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects
  • Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies
  • Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits
  • Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance
  • Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
  • The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
  • Skills:*
CRA, Monitoring, Medical Device, CRO, ICH, GCP, FDA, Clinical Research, Clinical Trials

  • Top Skills Details:*
CRA,Monitoring,Medical Device

  • dditional Skills & Qualifications:*
Bachelor of Science Degree 4-5 Years + experience with a Sponsor or CRO Site Monitoring Experience Work experience at more than 1 company Experience with set-up monitoring plan, conducted site monitoring, and conducted site close-out. Medical Device preferred, Pharma OK, CRO OK

  • Experience Level:* - Entry Level

Job Tags

Work experience placement, Interim role, Local area,

Similar Jobs

Emergent Financial Group

Remote Life Insurance Producer — High Pay, Leads & Training Job at Emergent Financial Group

 ...can start earning residuals from day one. Candidates must be at least 18 years old, pass a background check, and have no prior sales experience required. Join us to become part of a supportive team and succeed without cold calling.#J-18808-Ljbffr Emergent Financial Group

University of Georgia

Tree Surgeon I Job at University of Georgia

 ...This is a manual labor position on a tree care crew, involving the safe operation of various equipment, including but not limited to mini skid steers, skid steers, manual transmission tractors, dump trucks, bucket trucks, and chainsaws. The individua Surgeon, Healthcare... 

Minnesota Department of Employment and Economic Development

Fraud Risk and Audit Supervisor - State Program Administrator, Director-Paid Leave Job at Minnesota Department of Employment and Economic Development

 ...communities throughout Minnesota. Working Title: Fraud Risk and Audit Supervisor Job Class: State Program Administrator, Director...  ...Classified Bargaining Unit/Union : 216 - Middle Management Association/MMA FLSA Status : Exempt - Executive Designated in... 

CoolSys - Refrigeration and HVAC Systems

Foreman Installation Refrigeration - Commercial & Industrial Job at CoolSys - Refrigeration and HVAC Systems

 ...offer more than just a job-we provide stability, growth, and industry-leading benefits for our employees. No wonder Newsweek named...  ...your career while working with top-tier clients in the HVAC and refrigeration industry! Responsibilities This position is... 

Jackson Nurse Professionals

Travel Outpatient Clinic RN Job at Jackson Nurse Professionals

 ...Job Description Jackson Nurse Professionals is seeking a travel nurse RN PreOp / PACU - Post Anesthesia Care for a travel nursing...  ...travel nurse staffing solutions to over 500 hospitals, outpatient clinics, and home health clients nationwide. Awarded Best of Staffing...