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Clinical Research Coordinator

EPW Curesearch LLC

Plano, texas


Job Details

Full-time


Full Job Description

A multi-year Clinical Research Coordinator (CRC) position is available at our research site in Plano, TX with an initial focus on an active pulmonary study from a major pharmaceutical sponsor. Working independently under the Research Program Manager, the CRC will be responsible for carrying out clinical research studies, including but not limited to participant recruitment and enrollment, scheduling study visits, carrying out study procedures, data collection and transfer to data repositories, and maintaining study records. The CRC must be able to work in a medical clinic setting supporting the principal investigator (PI) with protocol requirements, display a high degree of initiative, and have excellent interpersonal, organizational, and time management skills.

The company is hiring full-time and part-time positions.

Interested candidates should send a current resume and introductory cover letter to [email protected]

May perform some or all the following:

  • Directly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth, or in-person. 
  • Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, company policies, FDA requirements or other medical site policies. 
  • Coordinate and schedule study procedures as per protocol. 
  • Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI. 
  • When outside of protocol, presents evidence and provides options (within scope of protocol) to PI. 
  • Screen, recruit, enroll and follow subjects according to protocol guidelines. 
  • May also assist with the consent process maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools. Assist in developing and implementing research studies to include new study application and enrollment planning, IRB submission, eReg, eConsent processes.
  • Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work requires familiarity with research budgets to assist with or develop study budgets. 
  • May perform research billing activities, as needed, based on size of department (including linking patient calendars). 
  • May review and abstract information from medical records for verification of eligibility for trials, as needed.
  • Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. 
  • Review research study protocols to ensure feasibility. 
  • Assist in developing website or other social media for marketing/recruiting of clinical research study. 
  • Develop proficiency in the clinical trial management system, electronic medical record, and other required data entry systems. 
  • Maintain subject level documentation duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing, or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. 
  • Performs other duties as assigned. 

EPW Curesearch LLC as part of an integrated healthcare company is developing into a leading provider of clinical trials and research solutions in the U.S. With deep experience in health clinic management, the company has established itself as a Site Management Organization (SMO) with active operations in large markets including Los Angeles, CA, Dallas, TX and Houston, TX. EPW Curesearch LLC partners with leading pharmaceutical brands and top medical specialists facilitating phase II & phase III interventional drug clinical trials in key therapeutic areas.

As an equal opportunity employer, EPW Curesearch prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

The company is hiring full-time and part-time positions.

Requirements

  • Bachelor’s or higher degree in medical or science related field and one-year clinical research experience. 
  • May consider additional years of experience or advanced degree in lieu of education or experience, respectively. 
  • ACRP or SOCRA certification a plus.

    • Work requires knowledge of basic and clinical research terminology, regulations, and procedures. 
    • Work requires strong computer skills (spreadsheets, databases, and interactive web-based software). 
    • Work requires ability to communicate effectively with various levels of internal and external contacts. 
    • Work requires ability to work with confidential information on daily basis. 
    • Proactively works to maximize results of the team and organization. 
    • Follows and understands the regulations for Protected Health Information (PHI) 
    • Work requires good communication skills. 
    • Work requires the ability to problem solve. 

Benefits

  • Paid Time Off (Vacation, Sick & Public Holidays)
  • Family Leave (Maternity, Paternity)
  • Training & Development
  • Work From Home
  • Wellness Resources

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