Associate Director Clinical Research
Posted on Aug 2, 2022 by Cleveland Diagnostics
Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Find out more about us on the website.
Cleveland Diagnostics offers an extremely robust benefits package that includes:
- 100% Employer paid employee medical coverage effective on your date of hire and 50% employer-paid spouse/dependent coverage.
- 100% Employer paid Medical, Dental, Vision, Group Term Life, Short term Disability, Long Term Disability.
- 4% retirement contribution match
- Incentive Performance Plan
- 15 days of paid vacation accrue in your first year
- 10 paid sick days
- 8 paid Holidays
- Flexible work schedule
As our R&D program expands and develops new cancer diagnostic assays using platform technologies, we currently have an immediate opening for a Sr. Clinical Research Coordinator. This is an excellent opportunity to be actively involved in the design, development, and performance of current and future clinical studies in a fast-paced and collaborative team environment.
The Sr. Clinical Research Coordinator will be responsible for coordinating the implementation and conduct of clinical research projects including negotiating clinical study agreements (CSA) and study budgets; developing and writing clinical study protocols under the direction of the study PI; IRB submissions; and data management; maintaining regulatory documents and binders; assisting and liaising with audits and regulatory agencies; conducting study site initiation, audit, and close-out visits. The Sr. Clinical Research coordinator will also be responsible for ensuring ethical conduct of clinical studies; compliance with research protocols and all regulatory standards.
Responsibilities and Duties
- Under the direction of the PI develop study objectives and design clinical studies to meet those objectives:
- Perform background literature reviews
- Develop comprehensive statistical analysis plans for each clinical study objective, including determination of adequate sample size and hypotheses as appropriate
- Prepare and submit protocols and other supporting documents to academic or commercial IRBs and any other regulatory submission documents as required by the protocol, including continuing review/modification submissions. Maintain IRB compliance for all studies
- Negotiate and finalize clinical study agreements (CSA) or clinical trial agreements (CTA) including study budgets.
- Analyze study data, and compile research findings.
- Develop and prepare study materials including informed consent documents, case report forms (CRFs), enrollment logs, sample collection kits, and shipping materials.
- Manage Regulatory Binders.
- Coordinate shipping of study materials and study samples.
- Develop procedures for patient screening, sample collection and processing.
- Manage sample collection, storage, and shipping materials.
- Maintain research records of study activity, including case report forms, clinical study database, testing, and storage in compliance with GCP and FDA guidelines.
- Maintain and manage clinical sample inventory.
- Train study personnel; maintain training and delegation of duties records
- Perform study site initiation, monitoring, and closeout visits.
- Seek out and cultivate working relationships with other clinical research organizations including biobanking facilities.
- BA/BS in a biological or medical field required. Master's degree in public health, clinical research, or other medical research field Preferred.
- Chemistry, biology, statistics, and writing courses preferred.
- Clinical Research Coordinator (CRC) certification required.
- At least seven years of related experience including IRB-regulated clinical research, protocol development statistical analysis, and report writing; or an equivalent combination of education and experience.
- Experience with Good Laboratory Practices (GLP), Good Documentation Practice (GDP), and Good Clinical Practice (GCP) required
- Experience with statistical software preferred
- Project management experience preferred
- Requires critical thinking skills and decisive judgment skills
- Must be a self-starter with high motivation level and eagerness to learn.
- Proficient computer skills especially with Microsoft applications (Word, Excel, PowerPoint, etc.).
- Effective written and verbal communication skills
- Works well in a collaborative and team-oriented environment
- Ability to manage and prioritize workload effectively
- Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens and repair equipment.
- May be required to stand for long periods of time.
- Visual acuity to examine specimens and reagents.
- Light lifting may be required.
- May be exposed to hazardous chemicals, biohazards, etc.
- Valid driver's license
- Occasional need to use personal vehicle for visits to local study sites
- Occasional out of state visits to remote study sites
- This position may require involvement outside of standard business hours
*This is NOT a remote position**
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
- 8 hour shift
- Monday to Friday
- Bonus pay
COVID-19 considerations: Full COVID-19 vaccination is required.