The coordinator is responsible for designing, updating, and controlling electronic and paper source documents for clinical trials in compliance with GCP and 21 CFR Part 11. They collaborate with site teams to ensure all protocol-defined data is accurately captured and maintained throughout the study lifecycle.
Requirements summary
Requires an Associate's degree in technology, biological science, or business, combined with at least one year of clinical research experience. Proficiency in computer applications and strong knowledge of clinical trial source design are highly preferred.
associate degreeQuality ControlOrganizational SkillsHIPAA ComplianceInterpersonal CommunicationElectronic Health RecordsMicrosoft OfficeTechnical WritingVersion ControlGCP GuidelinesClinical Trial Coordination21 CFR Part 11 ComplianceSource Document Design
Job description
Clinical Research Source Development Coordinator Department
Clinical
Systems
Employment
Type:
Full
Time
Location:
Alcanza
Corporate
Reporting To: Jordan Barker
Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, SC, TX, VA, and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
Position Summary
The Clinical Source Development Coordinator is an integral part of the Clinical team and will work closely with the Site teams and other key stakeholders in designing, updating, controlling, and releasing source (electronic or paper) for clinical trials.
Key Responsibilities In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies. Responsibilities may include but are not limited to:
Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs.
Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit.
Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents.
Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
Coordinating initial source review and update process.
Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial.
Benefits
Dental Insurance
Life Insurance
Vision Insurance
Medical Insurance
Long-term Disability Insurance
Short-term Disability Insurance
Health Savings Accounts
Supplemental Insurances
401k Plan With Safe Harbor Match
Updating current source documents according to new clinical study protocol amendments.
Activating studies and visits at the appropriate time.
Supporting Quality Control (QC) of source documents before it goes to the users.
Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out.
Maintaining a single tracker for the department to track source document design activities and the status of the activities.
Maintaining version control of all source documents.
Managing daily communication with site staff and other internal departments Remaining up to date with all assigned Clinical Study Protocol for study.
Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures.
Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork.
Participating in continuing education activities to maintain current knowledge of source document design and relevant software.
Performing all other duties that may be requested or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications
An Associate’s degree in technology, biological science, business, or related field, AND 1+ years of clinical research experience, OR and equivalent combination of education and experience is required. Strong knowledge of clinical trials and designing source documents (paper and electronic) is highly preferred. Experience as a CRC with diverse and complex clinical trials preferred.
Required Skills
· Proficiency with computer applications such as Microsoft applications, email, electronic health records, and web applications and the ability to type proficiently (40+ wpm).
· Strong organizational skills, attention to detail, and math proficiency.
· Well-developed written and verbal communication skills.
· Well-developed interpersonal and listening skills and the ability to work independently as well as with co-workers, subjects, managers, and external customers.
· Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
· Ability to be professional, respectful of others, self-motivated, and exemplify a strong work ethic.
· A high degree of integrity and dependability.
· Ability to work under minimal supervision, identify problems and implement solutions.
· Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
