Clincial Research Program Coordinator Non RN- CRO
Clincial Research Program Coordinator Non RN- CRO
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Salary Not Disclosed
1 Vacancy
Job Description
Overview:
The CONNECT Site Coordinators primary responsibility is the overall administrative coordination and management of open clinical trials in the research portfolio for the COllaborative Network for NEurooncology Clinical Trials (CONNECT). CONNECT is a 24 site international collaborative whose mission is to expand access and develop novel therapies for children with highrisk brain tumors. As primary study contact the scope of this role spans from study startup activities site trainings and activation subject enrollments tracking study data communications with all sites working with protocol writers to facilitate amendments and updates to study manuals working with the IRB and general study team.
Job Description Summary:
Job Description:
- Responsible for administrative management organization of and participation in program meetings and teleconferences including scientific meetings with corporate and nonprofit partners teaching conferences grand rounds journal club research seminars and CME programs.
- Works with Sponsored Projects Officer to manage program and project funds and dissemination of funding to collaborations sites in addition to the subcontracts with other sites.
- Provides funding opportunity notifications to PIs.
- Collaborates with department/center investigators in the development of IRB protocols grant submissions and scientific publications.
- Coordinates personnel needs for the program and projects; oversees and organizes training.
- Track projects and initiatives to ensure they move forward based on both timelines and budget; report to PI when progress is lacking and identifies needed action.
- May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (i.e. Data Management Biostats Medical Writing Regulatory Compliance etc..
- Manages and oversees IRB process for program projects and associated sites ensuring sites are submitting accurate and timely IRB submissions and maintain associated regulatory documents.
- Helps facilitate creation of source documents that ensure systematic data collection and/or aid in protocol and management and record keeping.
- Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects.
- Provides monitoring review and tracking of clinical data and preparation of study specific documents according to FDA regulations QA process implementation maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols.
- Work with principal investigators at each site to establish multisite monitoring plans for investigatorinitiated projects.
Education Requirement:
Bachelors degree preferred or Associate degree with two years clinical research experience or project management experience.
Licensure Requirement:
(not specified)
Certifications:
ACRP or SOCRA certification preferred within 12 months of hire and maintained throughout employment.
Skills:
- Demonstrated leadership skills
- Strong organizational skills
- Exceptional interpersonal written and verbal communication
- Ability to filter information discern importance and initiate plan for project completion
- Selfdirected results driven with the ability to manage workload.
- Ability to work independently and as part of a team.
- Working knowledge of data management software.
Experience:
Two years clinical research experience or project management experience.
Physical Requirements:
OCCASIONALLY: Bend/twist Lifting / Carrying: 010 lbs Lifting / Carrying: 1120 lbs Lifting / Carrying: 2140 lbs Pushing / Pulling: 025 lbs Pushing / Pulling: 2640 lbs Pushing / Pulling: 4160 lbs Reaching above shoulder Squat/kneel
FREQUENTLY: Sitting Standing Walking
CONTINUOUSLY: Audible speech Computer skills Decision Making Depth perception Flexing/extending of neck Hand use: grasping gripping turning Hearing acuity Interpreting Data Peripheral vision Problem solving Repetitive hand/arm use Seeing Far/near
Additional Physical Requirements performed but not listed above:
(not specified)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified nor is it intended to limit or modify the right of any supervisor to assign direct and control the work of employees under their supervision. EOE M/F/Disability/Vet
Required Experience:
Chief
Employment Type
Full-Time
