- The Medical Assistant will manage the clinical research trial process according to specific requirements, regulatory procedures, and protocols. In addition, the MA will help to ensure accuracy of data collection, resolution of queries, patient scheduling, management of study drug, data recording and follow up. Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications. Each Medical Assistant will work with the ultimate goal of ensuring data is collected and documented appropriately.
Primary Job Responsibilities:
- Work with providers including the Principal Investigator, UCCT staff, site staff, and patients as needed
- Adhere to the guidelines of FDA GCP/ICH as well as study protocol and company SOPs
- Coordinate, record and manage subject study data by maintaining accurate and complete source
- Complete case report forms and queries in a timely manner
- Perform quality control on subject data thats collected throughout the study
- Upload data and files to CTMS
- Oversee and maintain records of the proper receipt, storage, distribution and any shipments or transfer of investigational product.
- Work with the Principal Investigator, UCCT staff, site staff, patients, Sponsors, CROs and IRBs.
- Adhere to the guidelines of FDA GCP/ICH as well as study protocol and company SOPs.
- Complete feasibility questionnaires based on site information as well as complete regulatory start up packages
- Responsible for patient recruitment including submitting any advertising for sponsor and IRB approval as well as maintaining records of recruitment efforts and screening.
- Obtain informed consent under the guidance of the PI.
- Coordinate patient visits from screening to follow up.
- Ensure subjects meet all inclusion/exclusion criteria and have been properly consented prior to screening and enrollment into any clinical trial.
- Coordinate, record and manage subject study data by maintaining accurate and complete source.
- Perform physical assessments such as collecting height, weight, vitals, ECGs, etc…
- Perform basic lab procedures such as collecting, preparing, and shipping specimens.
- Communicate with IRBs, Sponsors, CROs, and outside vendors.
Required Experience and Skills:
- Associates/Bachelor Degree or/with equivalent experience in a related field or position
- Knowledge of clinical trials terminology and forms such as 1572, ICFs and SAE reporting
- Excellent written, computer and verbal communication skills
- Ability to organize and prioritize tasks
- Works well in a team but is self-driven
- OSHA certificate
- Experience with electronic data capture (EDC) & interactive response systems (IRT)
- Audit experience
- Prefer 2 years of research experience in a clinical research setting, Phase I-IV
- Current GCP and IATA certification preferred
- Understanding of HIPAA, federal, state and local laws relating to privacy and consent
- Knowledge of clinical trials terminology and forms such as 1572, ICFs and SAE reporting preferred