Atlanta Center for Medical Research

Scope

GENERAL SUMMARY OF DUTIES

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

Duties

Supervisory

  • 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

Administrative

  • 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

Qualifications

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

EDUCATION / EXPERIENCE

  • 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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