Fixed term, Full time
Opened 203 days ago
Closes 27 March 2022
About the Role
The Perron Institute for Neurological and Translational Science is involved in several Huntington’s disease research studies, and requires an experienced study coordinator to join the Clinical Trials team.
The Huntington’s Disease Study Coordinator will be responsible for all aspects of clinical trial coordination across the Huntington’s disease research studies. These include pharmaceutical sponsored trials, observational studies, and investigator led studies. The Huntington’s Disease Study Coordinator will work closely with other coordinators, investigators, nurses, and other professionals to achieve high quality research data and promote excellent outcomes for patients enrolled in clinical trials.
This role is offered on a full-time (1.0 FTE) fixed term basis for 6 months (with a possibility of a further 6 months on a part-time basis (0.5 FTE), dependent on available workload).
- Assist Start-up and HREC coordinator to prepare and submit clinical trial documents for HREC and governance review.
- Prepare study materials including PICF, CRFs, source documents, enrolment logs and drug/device accountability logs.
- Establish, organise and maintain study documents including but not limited to: regulatory binders, study specific source documentation, trackers and other materials in adherence with study protocols.
- Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Coordinate participant screening tests and procedures.
- Conduct study assessments and collect data as required by the protocol in line with relevant standard operating procedures and policies.
- Ensure timely completion of eCRFs and responses to queries.
- Liaise with study sponsors, medical staff, other hospital departments, study participants and third-party providers.
- Assist the PI with submission of accurate annual reports and timely close-out documents to HREC and applicable governing bodies.
- Prepare study documents for archiving.
- Coordinate and facilitate monitoring and auditing visits.
Skills and Experience
- Degree qualified in science, nursing, pharmacy, or a related discipline (or demonstrated equivalent competency).
- A minimum of 2 years’ experience coordinating clinical trials.
- Excellent communication and interpersonal skills with the ability to work both independently and as part of a team in an effective, pro-active and cooperative manner.
- High level of initiative and flexibility, and the ability to meet deadlines while balancing multiple priorities.
- Knowledge of Good Clinical Practice and applicable national and international laws and regulations.
- Ability to communicate effectively and sensitively with people with cognitive impairments.
- Good IT skills and proficient in the use of Microsoft Office applications.
- Knowledge or experience in dementia/neurological conditions would be highly regarded.