Assistant Screening Manager

About Company

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Job Description

The Assistant Screening Manager assists the Screening Manager and is the secondary recruitment contact for prospective study volunteers for awarded clinical studies; data-base review to identify volunteers that meet the required inclusion/ exclusion to ensure provision of quality research data to meet CPMI goals.

Responsibilities

• Thorough reading and understanding of study protocol volunteer’s inclusions and exclusions enrollment requirements.
• Assist the screening manager to ensure quality recruitment based on review of volunteer demographics for assignment to the appropriate clinical study.
• Notify the screening manager of recruitment status, trends, and unusual incidents.
• Assist with the preparation of the protocol specific screening package (i.e., medical history form, vitals form, inclusion/ exclusion form, etc.)
• Assist the screening manager with ensuring that potential subject meets the base protocol specific inclusions and exclusions.
• Provide top quality customer service and concurrently handle high levels of stress.
• Assist with ensuring the adequacy and accuracy of legible data obtained in source documents.
• Ensure and maintain safety and well-being of study participants.
• Participate in collaborative team efforts with other departments.
• Assist with the review of recruitment sheets and study schedules to advise supervisor of any issue that might cause delays in meeting the enrollment requirement, including stipends or study procedures.
• Assist with the accurate maintenance of records with regards to contact and enrollment logs for each protocol.
• Recognize the need to seek assistance or inform supervisor of specific issues.
• Follow the current OSHA, FDA and GCP/ICH regulations and guidelines.
• Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
• Discuss and administer Informed Consent Form.
• Maintains all current licensure required.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.
  
  

Skills And Qualifications

• Education and experience
• Certification in a clinical or allied health field with a minimum of six months experience in a medical facility
• Customer Service experience required.
• Clinical research experience preferred but not required.
• Good working knowledge of medical terminology and the clinical research process
• Bilingual skills are preferred but not required.
• Requirements
• Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Knowledgeable in medical terminology
• Excellent communication skills (interpersonal, written, verbal)
• Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)