Employment: Full time
ROMTech now seeks an experienced and ambitious Director, Clinical Research. The DCM will be responsible for writing study protocols and other research-related documents and will be expected to have expert-level knowledge in clinical trial practices and regulations.
Duties and Responsibilities
- Review contract, protocol, and Case Report Forms (CRFs) to assist in the development of the scope of the project
- Request project team resourcing, including members of the Medical, Data Management, Regulatory, Monitoring and Clinical Supplies departments as needed
- Coordinate and maintain the history of the project, the objectives of the current phase of the project, the strategies planned to reach the objectives, and directs revisions as necessary
- Assure that all project tasks are performed per SOPs
- Facilitate communication with and within all departments regarding the delegation of study tasks and team(s)
- Provides direction for study issues resolution
- Coordinate communication with management and fiscal personnel to ensure ongoing budget compliance through project completion, to ensure the completion of site budgets and contracts, and to ensure funder invoicing and CRA/monitor reimbursement as needed
- Provide oversight for the collection and quality assurance of all regulatory documentation
- Communicate effectively with the site’s designated clinical research associate to ensure that the clinical research studies are conducted in accordance with the applicable protocol, FDA regulations and GCP guidelines
- Facilitate communications between funders, CRAs, monitors, and sites to ensure that all protocol amendments, revisions to the Investigator’s Brochure and/or significant new adverse effects or risks with respect to study drugs are distributed to all participating sites
Requirements and Qualifications
- A minimum of 5 years of strong health care related background with prior oncology clinical and/or data services experience is required
- 3 years of project management experience is required
- A bachelor’s degree from an accredited college or university or a graduate of an accredited school or possess relevant professional experience
- Project management skills and the ability to interface with cross-functional teams
- Recognize and appropriately handle highly sensitive and confidential material and information
- Flexible and comfortable in a fast-paced environment, dealing with ambiguity, able to make the right decision and execute on tasks in a timely fashion
- Technically strong with advanced Microsoft Office skills: MS Word, Excel, and PowerPoint
- Professional demeanor and presentation
- Excellent verbal and written communication skills
- Strong problem solving and analytical skills; able to troubleshoot issues independently and drive them to closure
- Ability to work a flexible schedule and overtime as needed
- Must be a team player
- Ability to learn procedures and systems quickly
Qualified candidates, please respond and include:
- A cover letter detailing why you are the ideal fit for this job
- An up-to-date resume
Candidates who send resumes without the requested cover letter will not be considered.
Finally, openness, honesty, and candidness are qualities we respond to — as opposed to framing things in the right way with the right words. Please be who you are and let the dice roll.
We are an equal opportunity employer. Qualified Applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other classification protected under applicable Federal, State or Local law.