Bernice Edwin, Mph, Ccrp Email & Phone Number

Chicago, Il, Us

Chicago, Il, Us

Morrisville, Nc, Us

Drive the successful selection/activation of trial sites according to timeline, quality/scope and budget parameters.Collaborate with Project Managers to prepare and execute a site and patient recruitment/retention plan to meet project milestones.Create and maintain clinical monitoring plans utilizing approved templates; ensure effective communication and escalation instructions are incorporated in the plan and actioned appropriately. Lead and manage the clinical monitoring team with a focus on quality and timely deliverables.Ensure the timely completion of all visit reports; review them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective resolution of site issues. Monitor clinical operations metrics and timelines on a regular basis; track and analyze open actions, protocol deviations, queries aging reports, and assess the financial health of the clinical aspect of the study. Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock. Work cross functionally with Project Managers, Data Managers, and the Clinical Monitoring Services Team to deliver project deliverables. Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites. Serve as initial point of contact for all clinical management and monitoring concerns, escalating as required. May participate in Bid Defense activities.

Irvine, Ca, Us

• Responsible for study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing, and communicating the status of study progress and activities.• Partner with cross-functional team (e.g., clinical data management) with query management, data reviews and resolution. • Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases.• Lead in assessing current and new processes, identifying opportunities, and implementing solutions to improve process efficiency within and across related functional area.• Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority audits to ensure documents are compliant with all regulations.• Partner with clinical project manager in leading regular team meetings.• Prepare materials for steering and investigator meetings.• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP and regulatory requirements. • Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.• Provide oversight of and insights into trial activities to principal investigators and support staff, and study management and leadership staff.

Durham, North Carolina, Us

o Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. o Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. o Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. o Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Project Manager (PM), Clinical Lead (CL) and/or Site & Resource Manager (SRM). o Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. o Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. o May provide assistance to less experienced clinical staff.

Durham, North Carolina, Us

o Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. o Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. o Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. o Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Project Manager (PM), Clinical Lead (CL) and/or Site & Resource Manager (SRM). o Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. o Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. o May provide assistance to less experienced clinical staff.

Grand Blanc, Mi, Us

o Assist the investigators and clinicians in identifying and enrolling eligible patients into clinical trials. o Assist the physician with the informed consent process. Register, randomize eligible patients and submit accurately completed protocol data forms to the sponsoring group in a timely manner.o Educate patients and their families regarding research protocols, and keep them informed of procedures and changes in the studies in which they are participating.o Acquire and monitor investigational drugs; monitor study specific treatment calculations and dose modifications.o Act as an effective liaison between site investigators, IRB and sponsor.

o Manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met.o Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs. Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning.o Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents.o Perform and/or oversee site monitoring visits for clinical trials as needed. Review monitoring reports, protocol deviations and data queries & discrepancies for studies to ensure reliable quality data are delivered.o Track patient recruitment and progress to study timelines and support safety reporting & IRB submissions.o Coordinate the negotiation of site budgets within guidelines, and provide oversight for site payments per contracts.

Dublin, Ie

o Receives and processes product identification calls. o Determines if all necessary actions and responses have been sufficiently completed and documented which includes the product list database searches, requested correct package insert and MSDS identification and distribution via fax or mailing to the caller. o Responsible for identification and coordination of transfer of any query that is beyond direct approved responses and requires a Medical Communications Dept. staff member to offer a peer medical communications reply.

• Prepare patients for chiropractic physician’s care. • Observe and report the patient’s signs and symptoms to the physicians• Administer patient physiotherapy such as ultrasound and electrical stim as directed by and under the supervision of the physician• Other office duties including word processing, filing, scheduling, ledger entry, posting as instructed by physician or senior staff. • Adhere to ethical and legal standards of professional practice, recognize and respond to emergencies and demonstrate professional characteristics while following instructions.

o Worked on three major projects of the department. o Creating code book for data files. o Data management, cleaning, manipulation and analysis (Using SPSS and NVivo system). o Evaluate both quantitative and qualitative data & develop reports.

Wilmington, De, Us

o Provide assistance to patients in obtaining financial support for health care services, enrolling 100% of the eligible patients in Delaware’s Health Benefits Exchange, Medicaid, CHAP (Community Healthcare Access Program), Screening for Life and Sliding Fee Scale.o Compile completed monthly reports detailing financial status of patients, including collections, in a timely fashion, following up on any discrepancies. o Participate in committees, advocacy and outreach efforts as requested. o Conduct education and outreach to uninsured individuals. o Assist individuals to access and complete online applications, gather needed personal and financial documentation and complete the applications. Maintain contact and offer ongoing assistance as needed during the application process.

Philadelphia, Pennsylvania, Us

o Assist the pharmacist with billing, filling and labeling prescriptions. o Assist the customers with the proper guidance in prompt manner.o Stock control functions including stock level audits, expiry date checking, stock file maintenance, internal stock movements, recycling of stock returned to pharmacy. o Assist the pharmacist in administrating flu shots for patients at the pharmacy and in neighboring communities.o Train new pharmacy associates under the supervision of the pharmacist.

Master'S Degree, Public Health: Management

Bachelor Of Science (Bs), Kinesiology: Health Science