Manager, Clinical Research
We are seeking a qualified Clinical Research Manager to join our Parkinson's and Movement Disorder research team. We participate in a number of interesting Parkinson's and Movement Disorder studies and are looking for someone with clinical research and supervision experience.
Manages the daily operations of a clinical trial or research study. Implements standard operating procedures and ensures institutional and federal compliance. Manages financial aspects of clinical trials. Oversees data collection and documentation activities.
- Implements/maintains standard operating procedures (SOPs) for clinical research updating as required, ensures quality control of clinical trial enterprise, and maintains site certifications such as IATA, Blood Borne Pathogens, GCP, CITI and others as required by studies.
- Responsible for financial management of grants and clinical trials including budget planning and negotiations, resource allocation, invoicing, billing reconciliation and preparation of reports.
- Serves as point of contact for sponsors for new study participation, initiates the CDA process and discuss with potential PI so Pre-Study Site Visits can be arranged.
- Schedules, coordinates, and participates in the internal feasibility meeting, pre-site visit and site initiation visits.
- Supports investigators and clinical research staff with reporting, study monitoring, and site visits.
- Develops, implements, and monitors research protocols, procedures, and processes.
- May serve as back-up coordinator for study staff on any of their studies.
- May serve as study coordinator for studies as appropriate.
- Works with Senior Research Coordinator to maintain all regulatory documents required for studies as well as oversight and submissions to multiple IRBs (Advarra, WIRB, BCM, WUSTL).
- Oversees data collection and documentation activities; queries databases and prepares reports; manages compliance documents.
- Oversees the staff to ensure daily collection of temperature control logs for refrigerators and freezers used for I/P and blood, urine & CSF samples.
- Acts as a liaison between PI, and sponsors on regulatory quality control and quality assurance matters.
- Interfaces with regulatory bodies and other departmental or institutional management as needed.
- Supervises clinical research and administrative staff; provides training and guidance on regulations and best practices.
- May prepare research presentations such as posters and draft manuscripts.
- Oversees the maintenance of research equipment ensuring compliance with annual inspections and providing documentation to study sponsors or designees.
- Liaison with external partners with our Centers of Excellence for Parkinson Foundation, Tourette Association of America Centers, Wilson's Disease and other programs and prepares annual progress reports as requested.
- Consult with and assist faculty regarding the preparation of industry sponsored contracts, sponsored research agreements, Business Agreements and material transfer agreements.
- Bachelor's degree.
- Four years of relevant experience. Degrees in lieu of experience will not be accepted.
- Knowledge of Clinical Research processes a must.
- In depth experience with study management including IRB and grants & contracts.
- Effective communication skills, both orally and in writing.
- Experience with computer spreadsheets.
- Ability to understand and implement patient studies and protocols.
- Interpersonal skills necessary to coordinate research studies.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.