As a socially responsible health care employer and provider, we require our associates to show proof of annual influenza and COVID-19 vaccinations unless approved exemption is provided.
Planned Parenthood of Greater Ohio is seeking a full-time (37.5 Hours) Director of Clinical Research. Must reside in Ohio prior to start date.
SUMMARY
The Director of Clinical Research is a champion of our In This Together ethos with a particular emphasis on We Respect and Honor all People, We Try and We Learn, and We Return to our Mission. They will focus on establishing and leading a robust clinical research department partnering with industry, academic, foundation, and other Affiliates’ and PPFA partners. The Director of Clinical Research will lead high-quality and ethical research ensuring Planned Parenthood of Greater Ohio (PPGOH) is compliant with all accreditation requirements and research standards. Will work to improve and increase research capacity and operations for PPGOH. This position will involve strategic decision-making for research activities including business and protocol/proposal development, staffing models, operations, federal regulations, and study budgeting, as well as training and acting as an ambassador for PPGOH’s Clinical Research Program.
Come make a big impact with a mission driven organization that believes deeply in providing accessible and equitable care for all people. Planned Parenthood is committed to breaking down barriers to care including being available for some evening and weekend (Saturdays) hours.
WHAT YOU WILL BRING
- Bachelor’s degree in a health science or other related field
- Clinical research certificate from an accredited certifying agency required
- A minimum of 5 years’ experience in clinical research and 2 years managing associates
- Excellent written and verbal communication skills
- Exceptional organizational skills and attention to detail
- Strong problem-solving skills
- Proficient with Microsoft Office Suite
- Commitment to the ethos, values, and service standards of Planned Parenthood and ability to communicate these to associates, volunteers, prospective job applicants, and others in the community
WHAT YOU WILL DO
- Direct the PPGOH clinical research program, including the oversight and successful team buildout regarding infrastructure, hiring, training, and evaluation.
- Coordinate all activities and agreements, including proper IRB submissions and approvals between PPGOH, IRB, PPFA, educational institutions, pharmaceutical companies, CRO’s, commercial laboratories, affiliate legal counsel, etc. on all research studies conducted at PPGOH.
- Develop and maintain appropriate internal policies, operating procedures, protocols and workflows associated with the PPGOH Clinical Research Program, ensuring compliance with PPFA and federal, state, local regulations.
- Organize all vendor activities including stipend management system, courier services, and dry ice (not all inclusive).
- Function as the Research Representative at PPGOH meetings/events as needed.
- Ensure that the clinical research department supplies are maintained at adequate levels. Has authorization to order supplies as needed to fulfill this requirement.
- Develop annual budget and revenue goals for the Research Department in collaboration with the Chief Financial Officer.
- Create study-specific budgets that ensure compliance with Fair Market Value stipulations and IRS regulations for non-profit entities.
- Report monthly HC allocations, Research Accounts payable/receivable, HC research RVU’s, stipends and department revenue to PPGOH finance department.
- Effectively manage the research department’s budget in achieving net revenue goals, includes monthly revenue reporting, AR account reconciliation, invoicing to sponsors, check requests, etc.
- Coordinate, train, communicate with the Chief Operating Officer, VP of Patient Services, Director of Clinical Training, Practice Managers, and patient care staff to achieve optimum Health Center participation in Health Center integrated research.
- Manage and coordinate CITI training in compliance with PPFA SOP’s/manual for Research for all HC staff including new hires.
- Coordinate advertising and marketing to promote the PPGOH Clinical Research Department to industry sponsors and other affiliated agencies, or to promote specific studies to the community in collaboration with the Research Recruiter/Trainer and PPGOH Communications and Marketing Department.
- Ensure compliance with applicable PPGOH, PPFA, ODH, state of Ohio and U.S. policies, procedures, regulations, and laws related to human subject research.
- Ensure all medical records, source documents, case report forms and other research and clinical documents are managed and maintained according to all applicable policies, procedures, regulations, and laws with specific focus on confidentiality, privacy, and HIPAA.
- Ensure compliance with PPGOH’s diversity, equity, and inclusion policies in hiring, terminating, transferring, and promoting associates within the Clinical Research Department.
- Ensure research associates are adequately trained on relevant regulations/guidelines such as IATA, Protection of Human Subjects, PPFA SOP’s, Good Clinical Practices, and protocol specific information, and ensures that such documentation is maintained centrally and in study specific files for continuity of communication with regulatory bodies.
- Ensure complete confidentiality of research subjects including proper and prompt transfers, purging, storage, and retention of records.
- Coordinate and communicate with Principal Investigator(s) regarding the feasibility of new studies, status of existing studies, and requests for audits/monitoring visits.
- Collaborate with appropriate parties to develop and implement investigator-initiated research studies.
BENEFITS
- Paid Time Off
- Paid Parental Leave
- Medical 90% employer-paid base medical plans for single coverage
- Dental
- Vision 100% employer paid
- Life Insurance 100% employer paid
- Accidental Death & Disability 100% employer paid
- Long Term/Short Term Disability 100% employer paid
- 401(k) with matching employer contribution up to 4%
- Nine (9) paid holidays per year
- Two (2) paid floating holidays per year
PROMISE TO OUR ASSOCIATES
Planned Parenthood has served Ohioans with safe, accessible, and affordable health care for 100 years and welcomed more than 100,000 patient visits to our health centers in 2020. Every day, we fight to provide this care to everyone, no matter their income level, insurance status, zip code, color, creed, or country of origin.
As a mission-driven health care provider, Planned Parenthood is dedicated to ending health disparities and achieving health equity among all races. We work on all levels through our health centers, educational programming, and public policy to make the greatest impact on the communities we serve.
In order to become the leading organization for high quality reproductive health care, we continuously strive to create a supportive work environment that results in a positive experience for patients and associates alike. We find this support in our In This Together workplace values and service standards that bring associates together and foster an inclusive culture.
Planned Parenthood of Greater Ohio (PPGOH) is an equal opportunity employer. We care for our business by ensuring that all of our decisions regarding the employment relationship, including the terms, conditions, and privileges of employment, are in accordance with our principles of equal opportunity.
As a matter of PPGOH policy we affirm that we respect and honor all people and we will not discriminate against employees or applicants for employment on the basis of sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender, gender identity, gender expression, race, color, ethnicity, religion, national origin, ancestry, age, disability, medical condition, genetic information, marital status, sexual orientation, political affiliation, military and veteran status, or any other legally protected characteristic.
In addition to the above commitments, PPGOH seeks to have employees that reflect the broad diversity of those that we serve and we encourage all who are ready to be In This Together to apply.
