Senior Clinical Research Associate (Western Based CRA) Job at Tigermed, Washington DC

aEpGSGZWM2FrT1BCbDhySTQwa1JzbjNjdWc9PQ==
  • Tigermed
  • Washington DC

Job Description

1. Job Purpose:

  • This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations;
  • The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2. Responsibilities:

  • Planning of project activities and study timelines based on project goal and sponsor's expectation;
  • Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project;
  • Develop the project management plan, monitoring plan etc as required for the study;
  • Develop study specific tools/forms, study templates as required for the study;
  • Develop and manage project budget;
  • Order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period;
  • Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc);
  • Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval;
  • Track study progress and ensure project is conducted according to the plan;
  • Communicate to monitors new study information, study timelines and goals, study requirements. Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management);
  • Submit the weekly project report to management (e.g. Project Director, Senior Management);
  • Study site selection, initiation (SIV) and clinical monitoring;
  • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience;
  • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations;
  • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol, and requirements;
  • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files;
  • Finalize budget and obtain signed contract from site, prior to site initiation visit;
  • Provide guidance and training to entry-level CRA/CRA I/CRA II in collaboration with Line Manager.

3. Qualifications:

  • Bachelor degree or above in Medical, Pharmacology or Biology related major;
  • Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
  • At least 1-3 years of CRA experiences;
  • Good command of written and verbal English;
  • Good skills on Microsoft Word, Excel, PPT and Outlook, etc.;
  • Other abilities such as Communication skills/Information-gathering skills. Knowledge and/or experience in medical practice is a plus.

Welcome passion and creative ideas' friends! Look forward to receiving your profiles.

Job Tags

Contract work,

Similar Jobs

SF Research Institute

Clinical Research Coordinator Job at SF Research Institute

 ...for business and financial management of our research site, as well as oversight of day-to-day operations. Responsibilities Perform...  ...Regulatory Documents Collection tracker, eTMF tracker, Health Canada submission tracker, Central IRB Submission tracker, Site... 

Ethos Veterinary Health

Oncology Veterinary Technician Job at Ethos Veterinary Health

 ...services including anesthesiology, cardiology, critical care, dentistry, emergency care, integrative medicine, internal medicine, neurology, oncology, physical rehabilitation, radioactive iodine therapy, surgery, and urgent care. About the job: Oncology team... 

CalOpps

Library Page (20591402) Job at CalOpps

 ...Mill Valley, 94941 Description PART-TIME PAGING STAFFMill Valley Public Library...  ...15 pm.Occasional availability to work evening events on some Wednesdays, Fridays, and...  ...numerically~Ability to work evenings and weekends, with some flexibility to cover shifts... 

Maverick Solutions Inc

Athlete / Sports Minded - Entry Level Marketing Assistant Job at Maverick Solutions Inc

 ...Join our dynamic team as an Entry-Level Marketing Assistant , where your drive, passion, and background in sports can fuel your success in the marketing industry . We offer a supportive atmosphere, paid training , and ample growth opportunities, perfect for individuals... 

Ultimate Staffing

Weekend Receptionist Job at Ultimate Staffing

Part-time weekend receptionist needed for busy Luxury automtive dealership in North Scottsdale. Must be available Saturday from 8:30AM to 6:30PM and Sunday from 11:00AM to 5:00PM Responsibilities Answers multi-line phone system Is responsible for greeting...