Clinical Research Associate
T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony forming unit per milliliter, or CFU/ml. Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis. Upon receiving regulatory clearance, we intend to commercialize T2Dx and T2 Candida and our goal is to launch these product candidates commercially in the United States in the first half of 2015.
T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.
We are seeking a talented and highly motivated individual to join our team as a Clinical Research Associate. This position will report directly to the Vice President, Clinical, Regulatory & Quality Assurance.
Responsible for site management in the conduct of clinical trials, inclusive of the following:
- Assists in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
- Acts as the key liaison between the company, clinical investigators and study site personnel.
- Initiates, monitors and conducts Study Close Out procedures at clinical study centers; inclusive of training of study site personnel, oversight of protocol adherence, data verification of source documents and accountability of all study supplies. Must be able to troubleshoot and resolve routine study conduct issues.
- Prepares project status and study reports.
- Provides prompt reporting and follow through of regulatory deviations and adverse event reporting.
- Assures compliance of clinical studies with Good Clinical Practice (GCP), Federal regulatory requirements, and T2Biosystems’ Standard Operating Procedures (SOPs). Timely reporting and follow up of compliance deviations.
- Responsible for the management of all clinical study supplies.
- Responsible for the preparation and maintenance of study master files.
- Responsible for study enrollment tracking and reporting at individual study centers.
- Coordinates all data entry activities with data management team including data clarification processing, review, and verification of investigator clarification responses.
- Works with clinical sites and data management team to facilitate resolution of all data management queries.
- Interfaces with clinical, regulatory, sales, marketing and administrative staff.
Skills and Experience:
- BS degree in in biology, physical sciences, nursing or other related field.
- Minimum of five years experience with clinical trials, either in industry or academic setting.
- Knowledge of FDA guidelines and regulations governing conduct of clinical trials.
- Interpersonal and communication skills necessary to interact with study site personnel and physicians.
- Ability to travel approximately 30%-40% of time.
- Strong organizational skills and ability to handle multiple priorities in a fast-paced environment.
- Must have excellent computer skills including Microsoft Office, Word, Power Point, Excel, Access, and clinical database management software.
Interested? Say hello to us and send a cover letter, along with your resume, to email@example.com. Please write the job title in the subject line.
- T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.