Atlanta Center for Medical Research

Scope

JOB TITLE – Research Assistant II (RA II)

GENERAL SUMMARY OF DUTIES – Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals; specifically, the creation and maintenance of source documents; observing strict adherence to ICH, GCP, protocol and ACMR guidelines, regulations and policies.

MANAGER – Clinical Trial Manager

SUPERVISES – None

Duties

DUTIES INCLUDE, BUT ARE NOT LIMITED TO:

  • Creating and maintaining screen books and patient charts for all assigned studies;
  • Preparing visits for the next day, ensuring accuracy of source documents and assessments;
  • Filing of lab results, EKG results, and other communication in designated patient charts;
  • Timely completion of data entry for all eCRF’s, as well as paper CRF completion and transmission;
  • Assisting Coordinators in assessments, including but not limited to, blood pressure and urine collection, EKGs and blood draws
  • Communicating with study participants, caregivers, third party vendors and laboratories as needed
  • Formatting ‘Note to File’ documents and other written communication;
  • Assisting Coordinators with scheduling, copying, faxing and other clerical tasks;
  • Aiding Coordinators in the facilitation of study monitoring visits;
  • Assisting Coordinators with resolution of lab results which may include scheduling retests and/or following up with the Lab Vendor and answering queries
  • Assisting Coordinators with corresponding with sponsors and ensuring sponsor emails are responded to in a timely manner
  • Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants;
  • Assist with completion of Pre-Randomization Forms
  • Other duties as assigned.

Qualifications

KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:

  • Knowledge of psychiatry; including specific study indications;
  • Knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.).
  • Knowledge of medical equipment and instruments to administer study subject care;
  • Skill in organization and record maintenance;
  • Skill in developing and maintaining effective working relationships with supervisors and co-workers;
  • Ability to complete paperwork with precision and attention to detail;
  • Ability to react calmly and effectively in emergency situations;
  • Ability to interpret, adapt and apply guidelines and procedures;
  • Ability to work independently as well as functioning as part of a team;
  • Ability to communicate clearly both orally and verbally.

EDUCATION – BA/BS preferred or 1-year experience in clinical research

EXPERIENCE – One (1) year experience in clinical research preferred

CERTIFICATE/LICENSE – CPR training provided

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00 a.m. to 4:30 p.m. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

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