Job Description
Job DescriptionSalary: $16-$19
Hillcrest Medical Research is looking for a Clinical Research QA/ Data Entry Coordinator. The QA/Data Entry Coordinator provides data quality expertise in relation to all clinical research trials. Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, HMR SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.
Essential Functions & Responsibilities:
Duties include but not limited to:
- Experience with clinical trial data
- Excellent data quality and management skills
- Excellent organizational and time management skills
- Excellent oral communication skills
- Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis.
- Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.
- Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
- Prepares for internal and external audits and FDA inspections.
- Attends staff meetings.
- Attends site initiation visits as needed.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Duties:
- Transcribe patient research data from source documents into sponsor data management systems (e.g., eCRFs)
- Manage data entry timelines according to sponsor requirements
- Manage data query resolution
- Proactively identify data discrepancies and work with research coordinators to prevent recurrence
- Perform QC activities when reviewing source documentation. Inform supervisor and research coordinator of findings and items that require resolution
- Translate data quality results into clear business impact statements to help understanding and adoption of data management practices
- Maintain compliance with all company policies and procedures
- Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills both written and oral.
- Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.
- Must be able to clearly communicate through written and verbal means with sponsors and staff.
Qualifications:
- Knowledge of ICH/GCP preferred
- Experience with various electronic data entry systems
- Detail-oriented
- Strong critical thinking skills
- Strong ability to multitask
- Strong computer skills
- Ability to communicate clearly and effectively (written and oral)
- Excellent interpersonal and customer service skills
Hillcrest Medical Research is an equal opportunity employer. Decisions of employment are made based on business needs, job requirements and applicants qualifications without regard to race, color, religion, gender, national origin, disability status, protected veteran status, genetic information and testing, family and medical leave, sexual orientation, gender identity or expression or any other status protected by law. Hillcrest Medical Research is a drug-free work place and all offers of employment are contingent upon passing a pre-employment drug screen.