Clinical Research Coordinator Ii-Osseo-Integration

Overview Join the HJF Team! HJF is seeking a Clinical Research Coordinator II to perform clinical research and patient treatment in conjunction with one or more specified clinical research protocols.

Supervised by either a Clinical Site Manager or designee. The Department of Defense Limb Optimization and Osseointegration Program (LOOP) located at the Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD, was initiated in 2015 and with the goal of advancing the field of osseointegration as a capability within the Military Health System (MHS). Osseointegration (direct skeletal attachment of prosthetic limbs) has the potential of delivering improved functionality and quality of life to patients with major limb amputations. Walter Reed National Military Medical Center is the lead surgical institution to examine and advance osseointegration capabilities into the MHS to benefit our combat veterans and other beneficiaries.

The applicant would work closely with DoD LOOP's principal investigators to coordinate and contributes to new grant and funding applications and help with conducting clinical research and patient treatment in conjunction with osseointegration and advanced surgical interventions for amputees. The applicant will be responsible for screening patients for eligibility in participation of research protocols, educating the patients about the research protocol, and consenting patients.

Acts as a liaison between the patients and physicians and serves as a resource for the patients.

Acts as a research case manager for the patient where appropriate. Helps schedule patients for appointment and visits. Will be responsible for Good Clinical Practices, following established regulatory protocols and managing and entering data for clinical trials.

Assist with regulatory submissions and actions and with monitoring audits/visits for protocols. They will be responsible for implementing SOPs, research protocols and polices for all assigned projects. They will be responsible for creating SOPs to train new clinical research coordinators.

They will help the principal investigators process and interprets experimental data, formulates hypotheses and design experimental protocols. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine.

We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

Responsibilities Monitors and assesses the clinical research site's patient recruitment and retention success. Reviews new patient records and screens patients for eligibility in participation of research protocol. Interviews patients for protocols and collects and analyzes appropriate data for recruitment purposes, determine patient commitment and obtains informed consent.

Educates patients about the research protocol, their roles in the protocols, and any other vital information. Acts as a liaison between patients and physicians and serves as a resource for the patients. Schedules patients for appointments and visits.

Assists with monitoring audits/visits for protocols. Travels from their assigned workplace to support protocols at other sites as needed Collects, organizes, catalogs, disseminates, and maintains appropriate files of current data. Maintains weekly/monthly status reports on all patients.

Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads. Performs research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring GCP are being adhered to and communicationg protocol deviations approriately per SOPs, GCP, and applicable regulatory requirements. Acts as a liaison between patients and physicians and serves as a resource for the patients.

Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practices. Schedules patients for appointments and visits.

Assists with monitoring audits/visits for protocols. Travels from their assigned workplace to support protocols at other sites as needed. Qualifications Education and Experience Bachelor's Degree.

Minimum of 3-5 years experience required. Required Knowledge, Skills, and Abilities Knowledge of federal and local regulations and policies pertinent to research involving human subjects. Excellent interpersonal and computer skills.

Ability to communicate effectively and to work with individuals of all levels. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Physical Capabilities Lifting:

Requires lifting materials up to 25 lbs. objects. Work Environment This position will take place primarily in a clinic setting. Some HJF employees are required to be fully vaccinated against COVID-19.

Proof of vaccination or an approved religious or medical accommodation will be required. Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.