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

WebFX

Remote Copywriter - Health Job at WebFX

 ...to very competitive base pay, we offer company profit-sharing, performance bonuses, and health insurance (including dental, vision, remote doctor, etc.). To aid in your success, we provide world-class digital marketing training (Organic SEO, Local SEO, PPC, Google... 

VitalCore Health Strategies

Psychiatric Nurse Practitioner Job at VitalCore Health Strategies

 ...Thanksgiving Day, and Christmas Day ~ Medical ~ Dental ~ Vision ~ Health Savings...  ...Protection ~ Pet Insurance ~ Employee Assistance Program and Discount Center ~401K & Plan...  ...PRACTITIONER SCHEDULE Full-Time PRN PSYCHIATRIC NURSE PRACTITIONER POSITION... 

Northeast Healthcare Recruitment, Inc.

Locum Tenens Opportunity for Nurse Practitioners Job at Northeast Healthcare Recruitment, Inc.

We are seeking dedicatedNurse Practitioners (NPs) and Physician Assistants (PAs) for locum tenenspositions in the Greenville, NC area.This position requires working 2-3 days per week and focuses on providing high-quality care to patients.This role focuses on conducting... 

ProCare Therapy

Education Account Executive Job at ProCare Therapy

 ...healthcare staffing brand supporting school districts nation-wide to fill a variety of healthcare roles (paraprofessionals, special education teachers, therapist, etc.). Is this something you want to be a part of? The ideal candidate will be experienced and/or passionate... 

Concierge Care- St. Augustine, FL

Join Our Team as Certified Nursing Assistant -HHA Job at Concierge Care- St. Augustine, FL

Be Your Own Boss and Start this week as a Certified Nursing Assistant - CNA - Nurses Aide! Our response time is usually within a few hours and our goal is to help get you in process and working this week!Pay between $16-20 per hour depending on the location, client,...