Career Detail

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.

Our lead therapeutics are in the following indications:

• Spinal Fusion
• Long Bone Repair
• Osteochondral Repair
• Dental and Facial Bone Repair
• Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.

POSITION SUMMARY:

We are seeking a capable Jr. Clinical Research Associate (CRA) to be responsible for assisting the clinical team in planning, initiating, and monitoring Clinical trial sites as well as tracking enrollment and site engagement activities. The Jr. CRA will also assist the Sr. CRA’s participation in the conduct of clinical trials to test drugs or devices for their effectiveness, risks, and benefits to ensure that they are safe for their intended use.

The successful candidate will administer authorizations to ship products, organize payment of site and related invoices, and track performance of sites against forecasted enrollments and budgets. Additional activities include working on novel combination products, devices, and drugs as well as writing, reviewing, planning, and executing documents related to the clinical trial, including tracking and planning site visits, SOPs, activity lists, etc.

Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new product to monitor safety and side effects.

RESPONSIBILITIES:

These tasks vary depending on the product under study and the investigational site. Typically, the Jr. CRA will assist the Sr. CRA with these tasks and will QA any reports or documents that go into the trial Master file.

• Maintain the Trial Master File, along with the QA Manager and Clinical Project Manager.
• Assist in developing and writing trial protocols (outlining purpose and methodology)
• Present trial protocols to a potential study site.
• Verify that CRA’s have completed and monitored data collection forms, known as case report forms (CRFs).
• Verify no patient identifiable data in trial records.
• Direct matters for the Clinical Project Manager to coordinate with the ethics committee(s), which safeguards the rights, safety and wellbeing of all trial subjects.
• Assist in the development of Clinical SOPs, forms and other technical writing.
• Identify and assess the suitability of facilities to use as the clinical trial site.
• Secure all required site documents for sites identified as suitable (e.g. CVs, training certificates, licenses, etc.).
• Liaise with coordinators or investigators on conducting the trial.
• Verify CRA documents on set up of trial sites - ensuring each center has the trial materials, including the trial product often known as the investigational medicinal product (IMP).
• Forecast IMP needs for each site.
• Train the site staff to trial-specific industry standards and requirements.
• Assist in monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues.
• Assist in verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
• Enter completed CRFs from hospitals and general practices into the Trial Master File, as appropriate, if they are not in the Electronic Data Capture (EDC). Verify EDC entries against source records.
• Review visit reports, file, and collate trial documentation and reports in accordance with SOPs.
• Meet with team members to discuss on-going trials, results and any trends or adverse events.
• Ensure all unused trial supplies are accounted for.
• Archive study documentation and correspondence in trial TMF.
• Prepare final reports and occasionally manuscripts for publication.
• Assure payments of vendors and sites after verification that invoices are correct.

QUALIFICATIONS:

• Minimum 15 hrs. college credit in life sciences, medical sciences, or nursing. Relevant subjects include anatomy, biochemistry, biology, biomedical science, chemistry, immunology, microbiology, molecular biology, pharmacology or pharmacy, physiology, and toxicology. Experience in lieu of education may be acceptable.
• Two years of similar experience assisting with clinical trials.
• A thorough, working knowledge of Good Clinical Practices. Training will be provided as needed.
• Excellent written, verbal, and interpersonal communication skills.
• The ability to build effective relationships with trial center staff and colleagues.
• The ability to motivate others.
• Strong customer focus, presentation, and project management skills.
• An excellent grasp of numeracy and a keen eye for detail.
• The ability to multitask and think on your feet with a flexible and adaptable approach to work.
• Organizational, IT and administrative skills - the job involves a lot of documenting and recording information through computerized processes, such as clinical trial management systems and electronic data capture.
• A clean driving license may be required for travel between trial sites and your office.

TRAVEL AND SCHEDULE

• This is a full-time position located on-site in our Frederick, MD headquarters but may include opportunities for remote work.
• This role will be a mixture of desk-based work and site visits
• This role may require frequent travel, with the potential for spending three to four days per week away from the office, sometimes including overnight stays. Some companies operate a system whereby the CRA specializes in a specific disease area and covers the whole of the US.
• This position will involve close collaboration with Theradaptive partners.  Our partner companies have varying work schedules, and some evening work will be expected, although weekend or shift work will be uncommon.
• Some trials may be running abroad which will involve international travel.

https://www.theradaptive.com 

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.