Atlanta Center for Medical Research



Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and ACMR guidelines, regulations, and policies; assists PI(s) and Sub-I(s). Responsible for the delegation of tasks to Research Assistants ensuring the accurate completion and maintenance of study components and duties



  • Assessing the daily performance and productivity of RAs and Coordinators-in-Training along with the Research Project Manager

  • Delegating tasks to RAs and ensuring goals of accuracy and timeliness are met

  • On-going education and training of RAs regarding protocol specific tools, updates, roles, responsibilities, and expectations

  • Monitoring and tracking the completion of queries and providing prompt resolution

  • Assisting management in maintaining a positive and productive work environment

  • Maintaining patient safety and confidentiality

  • Keeping manager updated on the growth and progress of the RAs

  • Assisting the RAs in sponsor interactions

  • Other duties as assigned

Study Coordination

  • Successfully coordinating all aspects of participant involvement from study initiation until study completion

  • Ensuring necessary staff/departments are available to complete all portions of study visits

Study start-up:

  • Reviewing source documents and ensuring all required documents are thorough and accounted for

  • Responsible for study start approval

  • Participating in site initiation visits (SIVs) and review

  • Making sure assistance from outside vendors is accurate and received in a timely fashion

  • Making sure to get accurate information and supplies from sponsors (ie: source, protocol, scales, supplies, approvals, contacts, etc.) in accordance with applicable deadlines

  • Helping to ensure that recruitment deadlines and quotas are met and/or exceeded

  • Screening subjects for actively enrolling studies

  • Reviewing all subject history from Intake/Recruiters; Utilizing medical records for chart review

  • Confirming information with potential subject and study physician

  • Educating potential subjects, caregivers, and referral sources on protocol specific details and expectations

  • Working with the physician to address all medically-related questions and concerns as part of the informed consent process

  • Maintaining thorough knowledge of study specific inclusion/exclusion criteria

  • Gather and prepare all remote monitored data

  • QA all forms for accuracy upon completion

  • Coordinating scheduled visits and adhering to protocol visit windows and timelines

  • Performing safety and efficacy assessments per protocol

  • Vital signs, EKGs, and other assessments as assigned

  • Collaborating with the Research Pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen

  • Accurate completion of all study-related paperwork

  • Completion of source within 24 hours of subject visit

  • Completion of CRFs within 48 hours of subject visit

  • Prompt resolution of all study-related queries

  • Completion of “lab trackers”

  • Ensuring proper and timely QA review of source and making changes as needed

  • Timely reporting of study events (SAEs, protocol deviations, etc) to appropriate departments and other outside agencies (Sponsors, CRO’s, etc.)

  • Following subjects through study completion and creating follow-up care plan with physician, study subject and primary care provider

  • Attending SIVs and Investigator/Coordinator Meetings, as required

  • Ensuring preparation for and facilitating of all study monitoring visits

  • Prompt and professional communication with monitors and sponsors

  • Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members

  • Interacting with nursing/unit staff on a daily basis to ensure communication and accurate completion of source through daily chart review

  • Keeping management informed of study status and any study-related issues

  • Weekly communication of results as requested by manager

  • Other duties as assigned


  • Ensuring the effective management of Clinical Conductor (CC)

  • Coordinating length and location of visits

  • Creating ‘Note to File’ documents and other written communication

  • Scheduling and informing all departments of needed functions during patient visits

  • Scheduling necessary participant transportation

  • Properly managing and responding to voicemail and email

  • Alerting managers of any deficiencies noticed with work product, participants, staff, or facility

  • Other duties as assigned


Demonstrated expertise in:

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

  • Providing strong leadership and mentorship 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 emergency situations

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

  • Communicating clearly both written and verbally

Highly proficient in:

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

  • Meeting timelines and attention to detail

  • Prioritizing daily tasks with minimal guidance

  • Using electronic equipment (e.g., e-mail, computer, fax machine, copier, etc.)

  • Using medical equipment and instruments to administer study subject care

Established skill in:

  • Basic clinical skills to obtain patient vitals (measure pulse, respiration rate, blood pressure, EKG, height and weight, draw and process blood samples)

  • Medical terminology

  • Available to travel up to 25% of time (nationally and internationally) to include weekends as required


  • BA/BS strongly preferred

  • CCRC preferred but not required

  • 5 years’ experience in the clinical research field required without BA/BS

  • 1-2 years experience in clinical research preferred with BA/BS

  • At least 1 year of direct patient and sponsor interaction preferred

  • Previous experience as a Research Assistant at ACMR preferred, but not required

  • Previous supervisory experience strongly preferred

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