Planned Parenthood of Southern New England has an opening for a full time (37.5) Clinical Research Specialist to work out of our New Haven, CT Administrative Office
Areas of Responsibility:
- Participates in all activities of the Clinical Research department, both in the administrative offices and in the Health Centers
- Acts as a liaison between the Clinical Research department and the Health Centers, performing and facilitating the work of Health Center staff in recruiting and enrolling subjects
- Performs all specific study activities in accordance with Good Clinical Practices, Standard Operating Procedures, study protocols and compliance with all agency regulations including (but not limited to) universal precautions, OSHA regulations, sterile technique, hazardous waste disposal and HIPAA protections
- Performs a range of activities in support of clinical research studies such as: preparation of study materials, including document packets, binders and lab kits
- Recruits and screens potential study subjects, including obtaining consent
- Performs components of medical workup as needed, including obtaining blood and urine specimens from patients
- Assists in the processing and shipping of laboratory specimens per study protocols
- Follows procedures to protect and maintain the rights and confidentiality of all human study participants
- Provides care for subjects and data collection procedures in adherence with the assigned study protocol and in accordance with Good Clinical Practices and PPSNE Research Standard Operating Procedures
- Maintains financial tracking of subject compensation and preparation of invoices for study activities
- Maintains documentation required by study sponsors including source documentation, case report forms (print and electronic), study, regulatory, and patient binders, and maintains databases/spreadsheets to track study process and research data
- Participates in monitor visits and audits conducted by study sponsors, CROs, and the FDA as assigned by the Director, Clinical Research
- Works with study sponsor(s) as needed to facilitate daily operations and goals
- Works with Health Center management and staff to facilitate incorporation of clinical research into clinic operations and flow
- Must demonstrate flexibility and teamwork; understands the interaction between this position and others with whom the position works directly and indirectly
Educational Background:
Bachelor degree.
Skills/Experience:
- Must be willing and able to travel to various Health Centers 60-80% of time may be required and expected
- Must have a college degree, particularly in a health care discipline
- Must have a minimum of one year experience in research and/or health care
- Preference for experience as a research coordinator is requested
- Must have a certification in Human Subject Protection (NIH or other), IATA certification, and Cardiopulmonary Resuscitation Certificate (can be obtained following hire)
- Must have proficiency in Excel, Word, Outlook, internet, and ability to enter, track and manage data in various databases
Compensation/Benefits:
PPSNE offers a comprehensive benefit package which includes; Health, dental and vision insurance, retirement savings, tuition reimbursement, generous paid time off, a flexible spending account, wellness program and more.
Job Function:
Organization Info
Listing Stats
Post Date:
Nov 30 2017
Active Until:
Dec 30 2017
Hiring Organization:
Planned Parenthood Federation of America
industry:
Nonprofit