We are hiring a QC and Data Management Specialist II in Walnut Creek, CA. This is a full-time, in person role.
Responsibilities
ESSENTIAL JOB FUNCTIONS:
- Conduct a thorough and precise review of study charts utilizing SOPs, policies, GCP, GDP, and sponsor protocols. Indicate data points that are missing or discrepant and identify and report any trends to the QC Manager, Team Leads, and upper management.
- Accurately enter data into an eCRF/CRF system according to the sponsor provided eCRF/CRF guidelines in a timely manner.
- Identify and report missing data points or inconsistencies to the clinical research coordinator,
- investigators, and QC Manager, Team Leads, and/or upper management as soon as possible.
- Attend SIV meetings.
- Report any discrepancies between the source and CRF/eCRF immediately to the CRC and the QC
- Manager, Team Leads, and upper management.
- Resolve open queries thoroughly, accurately and in a timely manner.
- Assist in sponsor monitor visits to resolve queries in a timely manner.
- Work closely with other staff members and sponsor representatives in a professional manner.
- Assist with training and mentoring department new hires.
- Assist with developing and implementing key initiatives in the department.
- Assist with identifying, developing, and implementing process improvements.
- Perform all duties in a timely and cost-effective manner.
- Additional duties as assigned by management.
Required Skills
Requirements
- Bachelor’s degree or commensurate experience.
- Minimum of 2-3+ years’ relevant experience within the field of clinical or biological research.
Preferred Skills
Knowledge and Skills:
- Working knowledge of routine QC principles in a clinical research or closely related field.
- Basic knowledge of Good Clinical Practice (GCP) standards and clinical research industry guidelines/regulations.
- Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications.
- Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task.
- Must have strong written and verbal communication skills.
- Must have good critical thinking, decision-making, and problem-solving skills.
- Must be professional and have a strong work ethic.
- Must have the ability to adapt and take-on additional tasks as requested.
- Must have the ability to understand medical terminology and research concepts.
- Must have ability to identify appropriate subject care, relate in a professional and knowledgeable manner to physicians, pharmaceutical sponsors/CROs, and IRBs.
- Ability to work extended hours as required.
Schedule/Shift
HOURS: Monday to Friday, Day Shift, 40 hours per week
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
