Clinical Research Lead

Job Profile Summary

Coordinate and participate in clinical research studies ensuring that studies are carried out according to protocol, contracted scope of work, good clinical practice, sponsor and Avacare standard operating procedures (SOPs) and any relevant local guidelines and regulations.

Responsibilities

Provides clinical research support to investigators to prepare for and execute assigned research studiesReviews study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research dataCollects and submits regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the studyRecruits and screens patients for clinical trials and maintain subject screening and enrollment logsOrients research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visitsMaintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principlesSchedules and executes study visits and perform study procedures as delegated and supervised by the Principal InvestigatorHandles lab testing and analysis including preparation of specimen collection tubes and lab logisticsMonitors subject safety and report adverse events and reactions to Principal Investigator, study team members and IRBs as appropriateCorresponds with research subjects to troubleshoot study-related questions or concernsParticipates in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standardsActively involved in study data quality checking and query resolutionPerforms a variety of complex clinical research procedures including but not limited to electrocardiogram (ECG), lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administrationUpdates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical researchAssists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sitesMaintains a safe environment in accordance with site policiesActs as an advocate for research subjectsAddresses subject questions in a pro-active manner and take remedial action as requiredAssists and advise site staff in nursing practices and on the delivery of study care to subjectsReports any deviations from normal research practices to senior staff and implement agreed changes in the study care programAssists investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standardsAssists in providing training to new investigator site staff members on study-specific topics and requirementsMaintains adherence to investigator site staff training requirements by auditing and maintaining training recordsProvides guidance and supervision to lower level site staff to help provide that processes are carried out in line with protocols and SOP's, where applicableParticipates in study process reviews and enhancement efforts to support control of site unit budget, development of the research facilities and site services and the culture towards a high performing research study teamPrepares for and attend study monitoring visits, study audits and regulatory inspections with clinical research regulatory agenciesAdheres to standard operating procedures (SOPs) and other directives throughout this processAssists research site with coverage planning related to staffing and scheduling for research projects

Qualifications

Requires 2 - 3 years of prior relevant experienceRequires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experienceKnowledge of clinical trials.Advanced knowledge of the principals of Good Clinical Practices (GCP).In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.Skill in carrying out required clinical procedures such as spirometry testing or lab sample collection.Knowledge of medical terminology.Applicable certifications and licenses as required by country, state, and/or other regulatory bodies. e.g., Registered Nurse (RN).