Atlanta Center for Medical Research

Scope

GENERAL SUMMARY OF DUTIES – Responsible for coordinating the screening to randomization component of clinical trials with the strictest adherence to ICH, GCP, protocol, and ACMR guidelines, regulations, and policies; Responsible for the delegation of tasks to Research Assistants ensuring the accurate completion and maintenance of study components and duties.

REPORTS TO – Enrollment Manager

SUPERVISES – N/A

Duties

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Serves as primary Coordinator to facilitate participants are screened into appropriate trials as deemed fit by the Principal Investigator

  • Screens patient records, databases, and physician referral summaries for identification of prospective candidates for research protocols

  • Performs and directs the conduct of all screening visits to ensure adherence to the research protocol, sponsor, GCP and GPP guidelines

  • Interviews prospective subjects for participation in trials available at ACMR and obtains informed consent

  • Educates Research participants for participation and completion of research studies

  • Must have and maintain knowledge of all actively enrolling study protocols, specifically in-depth knowledge of Inclusion/Exclusion criteria needed to randomize appropriately

  • Ensures screened participants are randomized as soon as possible and schedules randomization visit with primary study coordinator

  • Collaborates with the Quality department to ensure EAF completion and submission to sponsor is done accurately

  • Follows participants during screening for transition to study coordinator including ensuring that all safety labs, vendor visits, EAFs, and other requirements needed during the screening phase have been completed, received and submitted appropriately prior to hand off to primary study coordinator

  • Maintains consistent enrollment in protocols and provides monthly written documentation of screening/enrollment/follow-up activities

  • Documents research related examinations, procedures, tests, and other activities in appropriate source charts deemed necessary at the screening visit

  • Ensure the creation of screen books for all actively enrolling studies

  • Identifies strategies to improve patient enrollment in research protocols in collaboration with Principal Investigator, Pre-Enrollment Department and Enrollment Manager

  • Participates in initiation visits/investigator’s meetings for assigned clinical trials

  • Other duties as assigned

Qualifications

KNOWLEDGE, SKILLS & ABILITIES

Demonstrated expertise in:

  • Possessing a thorough understanding of the requirements of each protocol

  • Determining that inclusion/exclusion criteria are applicable to the study population

  • Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials

  • Providing strong leadership and mentor ship to others

  • Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level

  • Crisis management and problem solving; ability to react calmly and effectively in emergent situations

  • Working independently as well as functioning as part of a team

  • Communicating clearly both written and verbally

  • Medical terminology

Highly proficient in:

  • In the use of technology required for the completion of study visits and study conduct

  • Completing paperwork with precision, accuracy, and attention to detail

  • Meeting timelines and attention to detail

  • Prioritizing daily tasks with minimal guidance

  • Using medical equipment and instruments to administer study subject care

  • Established skill in basic clinical skills to obtain patient safety measures (measure pulse, respiration rate, blood pressure, EKG, height and weight, draw and process blood samples)

A successful candidate will be responsible for ensuring participants are cared for by following the guidelines provided by the Protocol and Management. The ideal candidate will be a detail-oriented individual that is adaptable to change and has strong multitasking skills. The ideal person is a team player able to work in a fast-paced environment and is willing to adhere to the guiding principles of ACMR.

EDUCATION -MD

EXPERIENCE
3-5 years experience in the clinical research field required; at least 1 year of direct patient and sponsor interaction;

CERTIFICATE/LICENSE –CPR training provided; other training provided on an as needed basis

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00. to 4:30p.m. CRC’s are often required to see patients or 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 and medical/psychiatric diagnoses disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

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