Trial Documentation Services Associate II

ClinForce, Inc. is currently seeking a Trial Documentation Services Associate II in Malvern, PA. Successful candidate will be responsible for distributing, collecting, reviewing, approving, tracking, bar-code, and filing of initial set of site regulatory documentation required for shipment of study drug to investigative sites in conformance to all relevant laws, regulations, guidelines and internal SOPs and other procedural documents according to established timelines. Other duties include:
Establish and Maintain strong communication line between CTM study representatives and TDS group to understand study specific details that affect TDS functions.Be the primary site contact or local CRA for coordination of flow of site regulatory documents Lead the interaction with sites and other company departments to resolve regulatory document issues.
Review and approval of site-specific informed consent forms in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies according to established timelines.Ensure, if appropriate, that any procedural or medical or safety change within a site-specific informed consent form is acceptable to the study’s CTM and Therapeutic Area representatives.Ensure, if appropriate, that any modifications to legal wording within a site-specific informed consent form is acceptable to company's Legal Department.
Review and approval of updated/revised site regulatory documents, including site-specific ICFs, during the course of the clinical trial.
Input data into TDS database to track essential site regulatory documents on a study level. Assist CTM study team to maintain current study progress by providing regular status updates. Inform CTM study team of any outstanding documents required to complete the site’s initial regulatory document package. Inform CTM of any documents with an expiry date of pending expiration within set timelines
Forward copies of specific site regulatory documents to other departments within company, as required.
Coordinate translations of required documents, if applicable.
Review and approval of country-specific informed consent forms in conformance to all relevant laws, regulations, guidelines and internal SOPs and other procedural documents according to established timelines. Ensure, if appropriate, that any procedural or medical or safety change within a country-specific informed consent form is acceptable to the study’s CTM and Therapeutic Area representatives.Ensure, if appropriate, that any modifications to legal wording within a country-specific informed consent form is acceptable to company's Legal Department.
Assist Manager of TDS with any or all of the following: Develop and maintain applicable TDS documents, worksheets, and workflows related to the conduct of TDS activities at study-specific level. Ensure consistency in review of regulatory site documents within a trial and from trial to trial through training of other members of TDS. Measure cycle time of site regulatory and CTM required documents that pass through the TDS group through the collection and reporting of established metrics.
REQUIREMENTS
4-7 years of clinical or operative experience in clinical trials with a pharmaceutical company and/or CRO
Willingness to travel 10%
Bachelor's degree preferably in life science and/or health science disciplines