Medasource
Position:
Clinical Research Data Coordinator Location:
Onsite - Brentwood, TN Duration:
6-month Contract to Hire Schedule:
Day shift; M-F - 8am-4pm Start:
ASAP
Position Summary The Data Coordinator is responsible for EMR data abstraction, EDC data capture, assisting with AE/SAE reporting and study queries. Ensures all activities are conducted according to company SOPs, and all applicable GCP and ICH regulations and guidelines. Major Responsibilities: Duties include but are not limited to: Support data entry activities to meet study data needs and deadlines Data abstraction from diverse sources Obtain source documentation for patients enrolled into clinical trials and data registry Maintain Data Registry as directed Assist with Data validation, conflict resolution and quality assurance Supports Clinical Project Manager to meet industry trial data deadlines Obtain source documentation for patients enrolled into clinical trial Assist Clinical Project Manager with case report form completion Assist Clinical Project Manager with query resolution Assist in SAE reporting and tracking Create and maintain patient visit tracking spreadsheets Maintain and archive study documents Meet with clinical study sponsor representatives as requested Develop and maintain file management and collaboration systems Maintain calendar Initiate improvements, tools, processes, and forms to enhance the efficiency and quality of work Attend meetings as assigned and report on actions Participate in educational activities and programs Maintain strictest confidentiality Work closely and effectively with all other department colleagues Assist other staff as requested and performing other related work as needed. Throughout the conduct of the clinical trial assesses adherence to HRI SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines All other duties as assigned Education & Experience: High School Diploma - Required Bachelor’s Degree - Preferred 1+ years of experience in healthcare, research, or other science related field - Required
Knowledge, Skills, Abilities, Behaviors:
Knowledge: Knowledge of scientific, medical, and regulatory terms Must have an understanding of clinical research process Knowledge of GCP and GMP
Skills: The proficiency to perform a certain task Professional writing and communicating skills required Organizational and prioritization skills required Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel High computer literacy and ability to learn new software if required
Abilities: An underlying, enduring trait useful for performing duties Ability to work both collaboratively and independently Interpersonal skills, detail oriented, and meticulous Ability to multi-task in fast paced environment is essential. Ability to manage, organizes, and makes decisions Travel Required No Travel: The job does not require any travel.
Clinical Research Data Coordinator Location:
Onsite - Brentwood, TN Duration:
6-month Contract to Hire Schedule:
Day shift; M-F - 8am-4pm Start:
ASAP
Position Summary The Data Coordinator is responsible for EMR data abstraction, EDC data capture, assisting with AE/SAE reporting and study queries. Ensures all activities are conducted according to company SOPs, and all applicable GCP and ICH regulations and guidelines. Major Responsibilities: Duties include but are not limited to: Support data entry activities to meet study data needs and deadlines Data abstraction from diverse sources Obtain source documentation for patients enrolled into clinical trials and data registry Maintain Data Registry as directed Assist with Data validation, conflict resolution and quality assurance Supports Clinical Project Manager to meet industry trial data deadlines Obtain source documentation for patients enrolled into clinical trial Assist Clinical Project Manager with case report form completion Assist Clinical Project Manager with query resolution Assist in SAE reporting and tracking Create and maintain patient visit tracking spreadsheets Maintain and archive study documents Meet with clinical study sponsor representatives as requested Develop and maintain file management and collaboration systems Maintain calendar Initiate improvements, tools, processes, and forms to enhance the efficiency and quality of work Attend meetings as assigned and report on actions Participate in educational activities and programs Maintain strictest confidentiality Work closely and effectively with all other department colleagues Assist other staff as requested and performing other related work as needed. Throughout the conduct of the clinical trial assesses adherence to HRI SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines All other duties as assigned Education & Experience: High School Diploma - Required Bachelor’s Degree - Preferred 1+ years of experience in healthcare, research, or other science related field - Required
Knowledge, Skills, Abilities, Behaviors:
Knowledge: Knowledge of scientific, medical, and regulatory terms Must have an understanding of clinical research process Knowledge of GCP and GMP
Skills: The proficiency to perform a certain task Professional writing and communicating skills required Organizational and prioritization skills required Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel High computer literacy and ability to learn new software if required
Abilities: An underlying, enduring trait useful for performing duties Ability to work both collaboratively and independently Interpersonal skills, detail oriented, and meticulous Ability to multi-task in fast paced environment is essential. Ability to manage, organizes, and makes decisions Travel Required No Travel: The job does not require any travel.