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

TBG | The Bachrach Group

Senior Cost Accountant Job at TBG | The Bachrach Group

 ...Bachrach Group is partnered with one of the leading chemical manufacturing companies globally on their search for a SENIOR COST ACCOUNTANT . The ideal candidate will have at least 5 years of accounting experience within the chemical manufacturing industry, oil and gas... 

Guardian Angel Senior Services

PCA - Certified or Will Train Job at Guardian Angel Senior Services

 ...GUARDIAN ANGEL SENIOR SERVICES NOW HIRING Flexible Hours Available! Make your own schedule. *HMK- Homemaker *PCA- Personal Care Assistant *HHA- Home Health Aide *CNA- Certified Nurses Assistance We are looking for 5-Star Caregivers to provide... 

Bolt Medical

Shipping and Receiving Lead Job at Bolt Medical

 ...training certification Ability to invest time, as required, expediting or completing assignments which may necessitate working evening and / or weekend hours as necessary to meet business demands High level computer skills in Microsoft Office Suite Word, Excel, PowerPoint... 

Vitawerks

Nurse Aide Job at Vitawerks

 ...rates. Why sign up? Take charge of your schedule today and embrace the freedom of being your own boss. Explore numerous Certified Nursing Assistant (CNA) shifts across New Jersey . Benefits: Flexible Scheduling No Minimum Hours Commitment Access shifts... 

24 Seven Talent

Recruiter Job at 24 Seven Talent

24 Seven is partnering with a well-known AEC company to help them find a Contract Recruiter to join their team for this remote opportunity. This is a full-time, 4-6 month contract with potential to extend. While on contract you'd be eligible for benefits, including vision...